S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01598298
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 299
• Locations: 714
• Arms: 2
• Actual Duration (Months): 56.6
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.

PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Musculoskeletal Complications; Pain	Drug: duloxetine hydrochloride; Other: placebo	Phase 3

Detailed Description

OBJECTIVES:

Primary

• To assess whether daily duloxetine hydrochloride (duloxetine) decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), as measured at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF).

Secondary

• To assess whether daily duloxetine decreases worst joint pain in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.

• To assess whether daily duloxetine decreases pain interference in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.

• To investigate whether daily duloxetine improves functioning, pain, and stiffness in the knees/hips according to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale. (Exploratory)

• To investigate whether daily duloxetine improves function, pain, and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). (Exploratory)

• To investigate whether daily duloxetine improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES). (Exploratory)

• To investigate whether daily duloxetine improves the proportion of patients reporting changes for the better versus worst as measured by the Global Rating of Change Scale. (Exploratory)

• To investigate whether daily duloxetine decreases analgesic use.

• To investigate whether daily duloxetine increases adherence to, and reduces the discontinuation rate for, aromatase inhibitor (AI) therapy. (Exploratory)

• To assess whether patients receiving duloxetine as compared to placebo have improved depression as measured by the Patient Health Questionnaire (PHQ-9) at Weeks 6 and 12. (Exploratory)

• To explore the relationship between inherited variants in genes responsible for duloxetine metabolism and activity (COMT, HTR3A, SLC6A2, SLC6A4, CYP1A2, CYP2D6) and aromatase (CYP19A1) and change in pain with 12 weeks of treatment. (Exploratory)

• To explore the impact of treatment on serum inflammatory cytokine levels with 12 weeks of treatment at baseline and 12 weeks. (Exploratory)

• To bank blood samples for future correlative analyses. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to baseline pain score (4-6 vs 7-10), and prior taxane use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

• Arm II: Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

Patients complete the modified Brief Pain Inventory Short Form (BPI-SF) questionnaire at baseline and periodically during study treatment. Patients may also complete the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale, the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES), Global Rating of Change Scale, and the patient Health Questionnaire (PHQ-9).

Patients undergo blood sample collection at baseline and periodically during treatment for correlative studies, including biomarker and genetic studies.

After completion of study treatment, patients are followed up for 168 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 299 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
• Actual Study Start Date: May 15, 2013
• Actual Primary Completion Date: Mar 20, 2016
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.	Drug: duloxetine hydrochloride; Given PO; Other Names: NSC-744012
Placebo Comparator: Arm II Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.	Other: placebo; Given PO

Outcome Measures

Primary Outcome Measures

1. Average Joint Pain According to BPI-SF [Weeks 2, 6, 12, and 24; Week 12 reported]

   Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".

Secondary Outcome Measures

1. Worst Joint Pain According to the BPI-SF [Weeks 2, 6, 12, and 24; Week 12 reported]

   Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".

2. Pain Interference According to the BPI-SF [Weeks 2, 6, 12, and 24; Week 12 reported]

   Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating "Does not interfere" and 10 indicating "Completely interferes".

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Patients must be women with histologically confirmed estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive invasive carcinoma of the breast with no evidence of metastatic disease (M0)

• Patients must have completed mastectomy or breast-sparing surgery and must have recovered from all side effects of the surgery

• Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that began or increased after starting AI therapy; new musculoskeletal pain must not be due specifically to fracture or traumatic injury

• Patients must have completed the S1202 Brief Pain Inventory-Short Form (BPI-SF) within 7 days prior to registration; patients must have an "average pain" of at least 4 on the BPI-SF

PATIENT CHARACTERISTICS:

• Patients must be post-menopausal, as defined by at least one of the following:

• At least 12 months since the last menstrual period

• Prior bilateral oophorectomy

• Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the post menopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration OR

• Have been on LHRH agonist therapy for at least 3 months and estradiol levels drawn within 28 days prior to registration are consistent with the institutional normal values for post-menopausal state.

• Patients must have Zubrod performance status of 0-2

• Patients must have no known allergy or hypersensitivity to duloxetine or any of the inactive ingredients in the matching placebo

• Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:

• Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder

• History of alcohol or other substance abuse or dependence within 365 days prior to registration

• Chronic liver disease

• End-stage renal disease

• Uncontrolled narrow-angle glaucoma

• Clinically significant coagulation disorder

• Creatinine clearance > 30 mL/min

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both within 3 x upper limit of normal

• Total bilirubin within the upper limit of normal

• Patients must be able to complete study questionnaires in English or Spanish

• Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), or cancer involving the bone

• Patients must be willing to submit blood samples for correlative studies; baseline samples must be obtained prior to beginning protocol treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• If patients were treated with chemotherapy and/or radiation therapy, these treatments must be completed at least 28 days prior to study registration

• Concurrent bisphosphonate and trastuzumab therapies are allowed

• Patients should have recovered from all Grade 2 or higher side effects of chemotherapy and/or radiation therapy with the exception of alopecia and peripheral neuropathy

• Patients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days, but no longer than 12 months, prior to registration and plans to continue for at least an additional 180 days after registration

• Anastrozole (Arimidex®) 1 mg daily

• Letrozole (Femara®) 2.5 mg daily

• Exemestane (Aromasin®) 25 mg daily

• Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: treatment with phenothiazines, propafenone, flecainide, or linezolid; treatment with monoamine oxidase (MAO)-inhibitor within 14 days prior to registration; or current use of anticoagulation medication (e.g., heparin, warfarin)

• Patients must not require selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephirine reuptake inhibitors (SNRIs), or tricyclic antidepressants during study participation; patients must have been able to taper and discontinue treatment with these medications at least 7 days prior to registration; patients must not have taken duloxetine or milnacipran within 90 days prior to registration

• Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Breast Care and Surgery LLC	Anchorage	Alaska	United States	99508
2	Anchorage Oncology Centre	Anchorage	Alaska	United States	99508
3	Katmai Oncology Group	Anchorage	Alaska	United States	99508
4	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
5	Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
6	Fowler Family Center for Cancer Care	Jonesboro	Arkansas	United States	72401
7	Kaiser Permanente-Deer Valley Medical Center	Antioch	California	United States	94531
8	Sutter Auburn Faith Hospital	Auburn	California	United States	95602
9	Alta Bates Summit Medical Center-Herrick Campus	Berkeley	California	United States	94704
10	Mills - Peninsula Hospitals	Burlingame	California	United States	94010
11	East Bay Radiation Oncology Center	Castro Valley	California	United States	94546
12	Eden Hospital Medical Center	Castro Valley	California	United States	94546
13	Valley Medical Oncology Consultants-Castro Valley	Castro Valley	California	United States	94546
14	Sutter Davis Hospital	Davis	California	United States	95616
15	Epic Care-Dublin	Dublin	California	United States	94568
16	Bay Area Breast Surgeons Inc	Emeryville	California	United States	94608
17	Epic Care Partners in Cancer Care	Emeryville	California	United States	94608
18	Kaiser Permanente-Fremont	Fremont	California	United States	94538
19	Valley Medical Oncology Consultants-Fremont	Fremont	California	United States	94538
20	Kaiser Permanente	Fresno	California	United States	93720
21	Loma Linda University Medical Center	Loma Linda	California	United States	92354
22	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
23	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
24	Memorial Medical Center	Modesto	California	United States	95355
25	Kaiser Permanente-Modesto	Modesto	California	United States	95356
26	El Camino Hospital	Mountain View	California	United States	94040
27	Palo Alto Medical Foundation-Camino Division	Mountain View	California	United States	94040
28	Palo Alto Medical Foundation-Gynecologic Oncology	Mountain View	California	United States	94040
29	Sutter Cancer Research Consortium	Novato	California	United States	94945
30	Highland General Hospital	Oakland	California	United States	94602
31	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
32	Bay Area Tumor Institute	Oakland	California	United States	94609
33	Hematology and Oncology Associates-Oakland	Oakland	California	United States	94609
34	Tom K Lee Inc	Oakland	California	United States	94609
35	Kaiser Permanente-Oakland	Oakland	California	United States	94611
36	Palo Alto Medical Foundation Health Care	Palo Alto	California	United States	94301
37	Huntington Memorial Hospital	Pasadena	California	United States	91105
38	Valley Medical Oncology Consultants	Pleasanton	California	United States	94588
39	Kaiser Permanente-Redwood City	Redwood City	California	United States	94063
40	Kaiser Permanente-Richmond	Richmond	California	United States	94801
41	Kaiser Permanente-Roseville	Roseville	California	United States	95661
42	Sutter Roseville Medical Center	Roseville	California	United States	95661
43	Sutter General Hospital	Sacramento	California	United States	95816
44	Kaiser Permanente-South Sacramento	Sacramento	California	United States	95823
45	Kaiser Permanente - Sacramento	Sacramento	California	United States	95825
46	California Pacific Medical Center-Pacific Campus	San Francisco	California	United States	94115
47	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
48	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
49	Kaiser Permanente San Leandro	San Leandro	California	United States	94577
50	Doctors Medical Center- JC Robinson Regional Cancer Center	San Pablo	California	United States	94806
51	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
52	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
53	Palo Alto Medical Foundation-Santa Cruz	Santa Cruz	California	United States	95065
54	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
55	Sutter Pacific Medical Foundation	Santa Rosa	California	United States	95403
56	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
57	Kaiser Permanente-Stockton	Stockton	California	United States	95210
58	Palo Alto Medical Foundation-Sunnyvale	Sunnyvale	California	United States	94086
59	Northbay Cancer Center	Vacaville	California	United States	95687
60	Kaiser Permanente Medical Center-Vacaville	Vacaville	California	United States	95688
61	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
62	Sutter Solano Medical Center/Cancer Center	Vallejo	California	United States	94589
63	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
64	Presbyterian Intercommunity Hospital	Whittier	California	United States	90602
65	Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado	United States	80012
66	The Medical Center of Aurora	Aurora	Colorado	United States	80012
67	Boulder Community Hospital	Boulder	Colorado	United States	80301
68	Rocky Mountain Cancer Centers-Boulder	Boulder	Colorado	United States	80304
69	Penrose-Saint Francis Healthcare	Colorado Springs	Colorado	United States	80907
70	Rocky Mountain Cancer Centers-Penrose	Colorado Springs	Colorado	United States	80907
71	Porter Adventist Hospital	Denver	Colorado	United States	80210
72	Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
73	Presbyterian - Saint Lukes Medical Center - Health One	Denver	Colorado	United States	80218
74	Rocky Mountain Cancer Centers-Midtown	Denver	Colorado	United States	80218
75	SCL Health Saint Joseph Hospital	Denver	Colorado	United States	80218
76	Rocky Mountain Cancer Centers-Rose	Denver	Colorado	United States	80220
77	Rose Medical Center	Denver	Colorado	United States	80220
78	Colorado Cancer Research Program NCORP	Denver	Colorado	United States	80222
79	Mercy Medical Center	Durango	Colorado	United States	81301
80	Southwest Oncology PC	Durango	Colorado	United States	81301
81	Comprehensive Cancer Care and Research Institute of Colorado LLC	Englewood	Colorado	United States	80113
82	Swedish Medical Center	Englewood	Colorado	United States	80113
83	Mountain Blue Cancer Care Center	Golden	Colorado	United States	80401
84	North Colorado Medical Center	Greeley	Colorado	United States	80631
85	Rocky Mountain Cancer Centers-Greenwood Village	Greenwood Village	Colorado	United States	80111
86	Rocky Mountain Cancer Centers-Lakewood	Lakewood	Colorado	United States	80228
87	Saint Anthony Hospital	Lakewood	Colorado	United States	80228
88	Rocky Mountain Cancer Centers-Littleton	Littleton	Colorado	United States	80120
89	Littleton Adventist Hospital	Littleton	Colorado	United States	80122
90	Rocky Mountain Cancer Centers-Sky Ridge	Lone Tree	Colorado	United States	80124
91	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
92	Longmont United Hospital	Longmont	Colorado	United States	80501
93	Rocky Mountain Cancer Centers-Longmont	Longmont	Colorado	United States	80501
94	McKee Medical Center	Loveland	Colorado	United States	80539
95	Parker Adventist Hospital	Parker	Colorado	United States	80138
96	Rocky Mountain Cancer Centers-Parker	Parker	Colorado	United States	80138
97	Saint Mary Corwin Medical Center	Pueblo	Colorado	United States	81004
98	Rocky Mountain Cancer Centers - Pueblo	Pueblo	Colorado	United States	81008
99	Rocky Mountain Cancer Centers-Thornton	Thornton	Colorado	United States	80260
100	SCL Health Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
101	University of Connecticut	Farmington	Connecticut	United States	06030
102	Greenwich Hospital	Greenwich	Connecticut	United States	06830
103	Smilow Cancer Hospital Care Center at Saint Francis	Hartford	Connecticut	United States	06105
104	Middlesex Hospital	Middletown	Connecticut	United States	06457
105	Kaiser Permanente-Capitol Hill Medical Center	Washington	District of Columbia	United States	20002
106	Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
107	Jupiter Medical Center	Jupiter	Florida	United States	33458
108	Cancer Center of South Florida-Lake Worth	Lake Worth	Florida	United States	33461
109	The Watson Clinic	Lakeland	Florida	United States	33805
110	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
111	Florida Hospital Orlando	Orlando	Florida	United States	32803
112	Sacred Heart Hospital	Pensacola	Florida	United States	32504
113	University Cancer and Blood Center LLC	Athens	Georgia	United States	30607
114	Augusta University Medical Center	Augusta	Georgia	United States	30912
115	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
116	South Georgia Medical Center/Pearlman Cancer Center	Valdosta	Georgia	United States	31602
117	Hawaii Oncology Inc-Pali Momi	'Aiea	Hawaii	United States	96701
118	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
119	Hawaii Cancer Care Inc-POB II	Honolulu	Hawaii	United States	96813
120	Queen's Medical Center	Honolulu	Hawaii	United States	96813
121	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
122	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
123	Hawaii Cancer Care Inc-Liliha	Honolulu	Hawaii	United States	96817
124	Hawaii Oncology Inc-Kuakini	Honolulu	Hawaii	United States	96817
125	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii	United States	96819
126	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
127	Castle Medical Center	Kailua	Hawaii	United States	96734
128	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii	United States	96766
129	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
130	Kootenai Medical Center	Coeur d'Alene	Idaho	United States	83814
131	Kootenai Cancer Center	Post Falls	Idaho	United States	83854
132	Kootenai Cancer Clinic	Sandpoint	Idaho	United States	83864
133	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
134	Mac Neal Hospital	Berwyn	Illinois	United States	60402
135	Saint Joseph Medical Center	Bloomington	Illinois	United States	61701
136	Illinois CancerCare-Bloomington	Bloomington	Illinois	United States	61704
137	Illinois CancerCare-Canton	Canton	Illinois	United States	61520
138	Memorial Hospital of Carbondale	Carbondale	Illinois	United States	62902
139	Illinois CancerCare-Carthage	Carthage	Illinois	United States	62321
140	Centralia Oncology Clinic	Centralia	Illinois	United States	62801
141	University of Illinois	Chicago	Illinois	United States	60612
142	Weiss Memorial Hospital	Chicago	Illinois	United States	60640
143	Carle on Vermilion	Danville	Illinois	United States	61832
144	Cancer Care Center of Decatur	Decatur	Illinois	United States	62526
145	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
146	Heartland Cancer Research NCORP	Decatur	Illinois	United States	62526
147	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
148	Crossroads Cancer Center	Effingham	Illinois	United States	62401
149	AMITA Health Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
150	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
151	Illinois CancerCare-Eureka	Eureka	Illinois	United States	61530
152	Little Company of Mary Hospital	Evergreen Park	Illinois	United States	60805
153	Illinois CancerCare-Galesburg	Galesburg	Illinois	United States	61401
154	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
155	Hinsdale Hematology Oncology Associates Incorporated	Hinsdale	Illinois	United States	60521
156	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois	United States	61443
157	Illinois CancerCare-Macomb	Macomb	Illinois	United States	61455
158	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
159	Loyola University Medical Center	Maywood	Illinois	United States	60153
160	Illinois CancerCare-Monmouth	Monmouth	Illinois	United States	61462
161	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
162	Community Cancer Center Foundation	Normal	Illinois	United States	61761
163	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
164	Radiation Oncology of Northern Illinois	Ottawa	Illinois	United States	61350
165	Illinois CancerCare-Pekin	Pekin	Illinois	United States	61554
166	OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center	Pekin	Illinois	United States	61554
167	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61603
168	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
169	OSF Saint Francis Radiation Oncology at Peoria Cancer Center	Peoria	Illinois	United States	61615
170	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
171	Illinois CancerCare-Peru	Peru	Illinois	United States	61354
172	Valley Radiation Oncology	Peru	Illinois	United States	61354
173	Illinois CancerCare-Princeton	Princeton	Illinois	United States	61356
174	West Suburban Medical Center	River Forest	Illinois	United States	60305
175	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62702
176	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
177	Springfield Clinic	Springfield	Illinois	United States	62702
178	Memorial Medical Center	Springfield	Illinois	United States	62781
179	Cancer Care Specialists of Illinois-Swansea	Swansea	Illinois	United States	62226
180	Carle Cancer Center	Urbana	Illinois	United States	61801
181	The Carle Foundation Hospital	Urbana	Illinois	United States	61801
182	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois	United States	60555
183	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
184	Michiana Hematology Oncology PC-Crown Point	Crown Point	Indiana	United States	46307
185	Elkhart Clinic	Elkhart	Indiana	United States	46514-2098
186	Michiana Hematology Oncology PC-Elkhart	Elkhart	Indiana	United States	46514
187	Elkhart General Hospital	Elkhart	Indiana	United States	46515
188	Community Hospital East	Indianapolis	Indiana	United States	46219
189	Community Regional Cancer Care-North	Indianapolis	Indiana	United States	46256
190	Community Howard Regional Health	Kokomo	Indiana	United States	46904
191	IU Health La Porte Hospital	La Porte	Indiana	United States	46350
192	Premier Oncology Hematology Associates	Merrillville	Indiana	United States	46410
193	Franciscan Saint Anthony Health-Michigan City	Michigan City	Indiana	United States	46360
194	Woodland Cancer Care Center	Michigan City	Indiana	United States	46360
195	Memorial Regional Cancer Center Day Road	Mishawaka	Indiana	United States	46544
196	Michiana Hematology Oncology PC-Mishawaka	Mishawaka	Indiana	United States	46545
197	Saint Joseph Regional Medical Center-Mishawaka	Mishawaka	Indiana	United States	46545
198	Michiana Hematology Oncology PC-Plymouth	Plymouth	Indiana	United States	46563
199	Reid Health	Richmond	Indiana	United States	47374
200	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
201	Michiana Hematology Oncology PC-South Bend	South Bend	Indiana	United States	46601
202	Northern Indiana Cancer Research Consortium	South Bend	Indiana	United States	46628
203	Porter Memorial Hospital	Valparaiso	Indiana	United States	46383
204	Michiana Hematology Oncology PC-Westville	Westville	Indiana	United States	46391
205	Mary Greeley Medical Center	Ames	Iowa	United States	50010
206	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa	United States	50010
207	McFarland Clinic PC-Boone	Boone	Iowa	United States	50036
208	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
209	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
210	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
211	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
212	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa	United States	50309
213	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
214	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
215	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
216	JCHC McCreery Cancer Center	Fairfield	Iowa	United States	52556
217	McFarland Clinic PC-Trinity Cancer Center	Fort Dodge	Iowa	United States	50501
218	McFarland Clinic PC-Jefferson	Jefferson	Iowa	United States	50129
219	McFarland Clinic PC-Marshalltown	Marshalltown	Iowa	United States	50158
220	Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
221	Ottumwa Regional Health Center	Ottumwa	Iowa	United States	52501
222	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
223	Mercy Medical Center-Sioux City	Sioux City	Iowa	United States	51104
224	Saint Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
225	Methodist West Hospital	West Des Moines	Iowa	United States	50266-7700
226	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
227	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
228	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
229	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
230	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
231	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
232	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
233	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67905
234	Cancer Center of Kansas-Manhattan	Manhattan	Kansas	United States	66502
235	Cancer Center of Kansas - McPherson	McPherson	Kansas	United States	67460
236	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
237	Menorah Medical Center	Overland Park	Kansas	United States	66209
238	Saint Luke's South Hospital	Overland Park	Kansas	United States	66213
239	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
240	Kansas City NCI Community Oncology Research Program	Prairie Village	Kansas	United States	66208
241	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
242	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
243	Stormont-Vail Regional Health Center	Topeka	Kansas	United States	66604
244	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
245	Associates In Womens Health	Wichita	Kansas	United States	67208
246	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
247	Cancer Center of Kansas - Wichita	Wichita	Kansas	United States	67214
248	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
249	Wichita NCI Community Oncology Research Program	Wichita	Kansas	United States	67214
250	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
251	Baptist Health Corbin	Corbin	Kentucky	United States	40701
252	Oncology Hematology Care Inc-Crestview	Crestview Hills	Kentucky	United States	41017
253	Hardin Memorial Hospital	Elizabethtown	Kentucky	United States	42701
254	Baptist Health Lexington	Lexington	Kentucky	United States	40503
255	Baptist Health Louisville	Louisville	Kentucky	United States	40207
256	Baptist Health Madisonville/Merle Mahr Cancer Center	Madisonville	Kentucky	United States	42431
257	Owensboro Health Mitchell Memorial Cancer Center	Owensboro	Kentucky	United States	42303
258	Baptist Health Paducah	Paducah	Kentucky	United States	42003
259	Christus Saint Frances Cabrini Hospital	Alexandria	Louisiana	United States	71301
260	University Health-Conway	Monroe	Louisiana	United States	71202
261	Louisiana State University Health Sciences Center Shreveport	Shreveport	Louisiana	United States	71103
262	CHRISTUS Highland Medical Center	Shreveport	Louisiana	United States	71105
263	Harold Alfond Center for Cancer Care	Augusta	Maine	United States	04330
264	Eastern Maine Medical Center	Bangor	Maine	United States	04401
265	Central Maine Medical Center	Lewiston	Maine	United States	04240
266	Penobscot Bay Medical Center	Rockport	Maine	United States	04856
267	Kaiser Permanente-Woodlawn Medical Center	Baltimore	Maryland	United States	21244
268	Suburban Hospital	Bethesda	Maryland	United States	20814
269	Frederick Memorial Hospital	Frederick	Maryland	United States	21701
270	Kaiser Permanente-Gaithersburg Medical Center	Gaithersburg	Maryland	United States	20879
271	Kaiser Permanente - Largo Medical Center	Largo	Maryland	United States	20774
272	Sturdy Memorial Hospital	Attleboro	Massachusetts	United States	02703
273	Boston Medical Center	Boston	Massachusetts	United States	02118
274	Steward Saint Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135
275	Saint Anne's Hospital	Fall River	Massachusetts	United States	02721
276	Simonds-Sinon Regional Cancer Center	Fitchburg	Massachusetts	United States	01420
277	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
278	Norwood Hospital	Norwood	Massachusetts	United States	02062
279	Baystate Medical Center	Springfield	Massachusetts	United States	01199
280	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
281	Bixby Medical Center	Adrian	Michigan	United States	49221
282	Hickman Cancer Center	Adrian	Michigan	United States	49221
283	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
284	Michigan Cancer Research Consortium NCORP	Ann Arbor	Michigan	United States	48106
285	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
286	Bronson Battle Creek	Battle Creek	Michigan	United States	49017
287	McLaren-Bay Region	Bay City	Michigan	United States	48706
288	Spectrum Health Big Rapids Hospital	Big Rapids	Michigan	United States	49307
289	Great Lakes Cancer Institute	Clarkston	Michigan	United States	48346
290	Beaumont Hospital-Dearborn	Dearborn	Michigan	United States	48124
291	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
292	Henry Ford Hospital	Detroit	Michigan	United States	48202
293	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
294	Green Bay Oncology - Escanaba	Escanaba	Michigan	United States	49829
295	Weisberg Cancer Treatment Center	Farmington Hills	Michigan	United States	48334
296	Hurley Medical Center	Flint	Michigan	United States	48502
297	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
298	Singh and Arora Hematology Oncology PC	Flint	Michigan	United States	48532
299	Cancer Research Consortium of West Michigan NCORP	Grand Rapids	Michigan	United States	49503
300	Mercy Health Saint Mary's	Grand Rapids	Michigan	United States	49503
301	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
302	Green Bay Oncology - Iron Mountain	Iron Mountain	Michigan	United States	49801
303	Allegiance Health	Jackson	Michigan	United States	49201
304	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
305	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
306	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
307	McLaren-Greater Lansing	Lansing	Michigan	United States	48910
308	Sparrow Hospital	Lansing	Michigan	United States	48912
309	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
310	Mid-Michigan Medical Center - Midland	Midland	Michigan	United States	48670
311	Mercy Memorial Hospital	Monroe	Michigan	United States	48162
312	Toledo Clinic Cancer Centers-Monroe	Monroe	Michigan	United States	48162
313	McLaren Cancer Institute-Macomb	Mount Clemens	Michigan	United States	48043
314	McLaren Cancer Institute-Central Michigan	Mount Pleasant	Michigan	United States	48858
315	Mercy Health Mercy Campus	Muskegon	Michigan	United States	49444
316	Lakeland Community Hospital	Niles	Michigan	United States	49120
317	McLaren Cancer Institute-Northern Michigan	Petoskey	Michigan	United States	49770
318	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
319	Lake Huron Medical Center	Port Huron	Michigan	United States	48060
320	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
321	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan	United States	48073
322	Saint Mary's of Michigan	Saginaw	Michigan	United States	48601
323	Lakeland Hospital	Saint Joseph	Michigan	United States	49085
324	Marie Yeager Cancer Center	Saint Joseph	Michigan	United States	49085
325	Providence Hospital-Southfield Cancer Center	Southfield	Michigan	United States	48075
326	Munson Medical Center	Traverse City	Michigan	United States	49684
327	William Beaumont Hospital - Troy	Troy	Michigan	United States	48098
328	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
329	Sanford Clinic North-Bemidgi	Bemidji	Minnesota	United States	56601
330	Essentia Health Saint Joseph's Medical Center	Brainerd	Minnesota	United States	56401
331	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
332	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
333	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
334	Essentia Health Saint Mary's Medical Center	Duluth	Minnesota	United States	55805
335	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
336	Fairview-Southdale Hospital	Edina	Minnesota	United States	55435
337	Lake Region Healthcare Corporation-Cancer Care	Fergus Falls	Minnesota	United States	56537
338	Unity Hospital	Fridley	Minnesota	United States	55432
339	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
340	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
341	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
342	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
343	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
344	Health Partners Inc	Minneapolis	Minnesota	United States	55454
345	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
346	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
347	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota	United States	55416
348	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
349	Regions Hospital	Saint Paul	Minnesota	United States	55101
350	United Hospital	Saint Paul	Minnesota	United States	55102
351	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
352	Lakeview Hospital	Stillwater	Minnesota	United States	55082
353	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
354	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
355	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
356	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
357	Family Cancer Center-Oxford	Oxford	Mississippi	United States	38655
358	Singing River Hospital	Pascagoula	Mississippi	United States	39581
359	Family Cancer Center-Southhaven	Southaven	Mississippi	United States	38671
360	Baptist Memorial Hospital-Desoto	Southhaven	Mississippi	United States	38671
361	Parkland Health Center-Bonne Terre	Bonne Terre	Missouri	United States	63628
362	CoxHealth Cancer Center	Branson	Missouri	United States	65616
363	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
364	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
365	University of Missouri - Ellis Fischel	Columbia	Missouri	United States	65212
366	Centerpoint Medical Center LLC	Independence	Missouri	United States	64057
367	Capital Region Medical Center-Goldschmidt Cancer Center	Jefferson City	Missouri	United States	65109
368	Freeman Health System	Joplin	Missouri	United States	64804
369	Mercy Hospital-Joplin	Joplin	Missouri	United States	64804
370	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
371	Heartland Hematology and Oncology Associates Incorporated	Kansas City	Missouri	United States	64118
372	Research Medical Center	Kansas City	Missouri	United States	64132
373	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
374	Liberty Radiation Oncology Center	Liberty	Missouri	United States	64068
375	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
376	Saint John's Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
377	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
378	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri	United States	63109
379	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
380	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
381	Sainte Genevieve County Memorial Hospital	Sainte Genevieve	Missouri	United States	63670
382	Cancer Research for the Ozarks NCORP	Springfield	Missouri	United States	65804
383	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
384	CoxHealth South Hospital	Springfield	Missouri	United States	65807
385	Missouri Baptist Sullivan Hospital	Sullivan	Missouri	United States	63080
386	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri	United States	63127
387	Billings Clinic Cancer Center	Billings	Montana	United States	59101
388	Montana Cancer Consortium NCORP	Billings	Montana	United States	59101
389	Saint Vincent Healthcare	Billings	Montana	United States	59101
390	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
391	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
392	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
393	Saint Peter's Community Hospital	Helena	Montana	United States	59601
394	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
395	Montana Cancer Specialists	Missoula	Montana	United States	59802
396	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
397	Community Medical Hospital	Missoula	Montana	United States	59804
398	CHI Health Good Samaritan	Kearney	Nebraska	United States	68847
399	Nebraska Hematology and Oncology	Lincoln	Nebraska	United States	68506
400	Nebraska Cancer Research Center	Lincoln	Nebraska	United States	68510
401	Southeast Nebraska Cancer Center	Lincoln	Nebraska	United States	68510
402	Faith Regional Medical Offices West	Norfolk	Nebraska	United States	68701
403	Great Plains Regional Medical Center	North Platte	Nebraska	United States	69103
404	Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
405	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
406	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
407	Oncology Hematology West	Omaha	Nebraska	United States	68124
408	Alegent Health Lakeside Hospital	Omaha	Nebraska	United States	68130
409	Oncology Hematology West PC	Omaha	Nebraska	United States	68130
410	Urology Cancer Center PC	Omaha	Nebraska	United States	68130
411	Creighton University Medical Center	Omaha	Nebraska	United States	68131
412	Regional West Medical Center	Scottsbluff	Nebraska	United States	69361
413	Cancer and Blood Specialists-Henderson	Henderson	Nevada	United States	89052
414	Comprehensive Cancer Centers of Nevada - Henderson	Henderson	Nevada	United States	89052
415	Las Vegas Cancer Center-Henderson	Henderson	Nevada	United States	89052
416	21st Century Oncology - Henderson	Henderson	Nevada	United States	89074
417	Comprehensive Cancer Centers of Nevada-Southeast Henderson	Henderson	Nevada	United States	89074
418	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
419	Cancer and Blood Specialists-Shadow	Las Vegas	Nevada	United States	89106
420	Nevada Cancer Research Foundation CCOP	Las Vegas	Nevada	United States	89106
421	Radiation Oncology Centers of Nevada Central	Las Vegas	Nevada	United States	89106
422	21st Century Oncology	Las Vegas	Nevada	United States	89109
423	HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway	Las Vegas	Nevada	United States	89109
424	HealthCare Partners Medical Group Oncology/Hematology-San Martin	Las Vegas	Nevada	United States	89113
425	Radiation Oncology Centers of Nevada Southeast	Las Vegas	Nevada	United States	89119
426	Cancer Therapy and Integrative Medicine	Las Vegas	Nevada	United States	89121
427	Cancer and Blood Specialists-Tenaya	Las Vegas	Nevada	United States	89128
428	Comprehensive Cancer Centers of Nevada - Northwest	Las Vegas	Nevada	United States	89128
429	HealthCare Partners Medical Group Oncology/Hematology-Tenaya	Las Vegas	Nevada	United States	89128
430	Comprehensive Cancer Centers of Nevada-Summerlin	Las Vegas	Nevada	United States	89144
431	Las Vegas Cancer Center-Medical Center	Las Vegas	Nevada	United States	89148-2405
432	21st Century Oncology - Fort Apache	Las Vegas	Nevada	United States	89148
433	Cancer and Blood Specialists-Fort Apache	Las Vegas	Nevada	United States	89148
434	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89148
435	HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills	Las Vegas	Nevada	United States	89149
436	Comprehensive Cancer Centers of Nevada - Central Valley	Las Vegas	Nevada	United States	89169
437	21st Century Oncology - Vegas Tenaya	Las Vegas	Nevada	United States	89182
438	Renown Regional Medical Center	Reno	Nevada	United States	89502
439	Alpine Hematology-Oncology	Reno	Nevada	United States	89503
440	Saint Mary's Regional Medical Center	Reno	Nevada	United States	89503
441	Reno Oncology Consultants	Reno	Nevada	United States	89519
442	Wentworth-Douglass Hospital	Dover	New Hampshire	United States	03820
443	Portsmouth Regional Hospital	Portsmouth	New Hampshire	United States	03802
444	AtlantiCare Surgery Center	Egg Harbor Township	New Jersey	United States	08234
445	Saint Peter's University Hospital	New Brunswick	New Jersey	United States	08901
446	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
447	Capital Health Medical Center-Hopewell	Pennington	New Jersey	United States	08534
448	Inspira Medical Center Vineland	Vineland	New Jersey	United States	08360
449	Inspira Medical Center Woodbury	Woodbury	New Jersey	United States	08096
450	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
451	Hematology Oncology Associates of Central New York-Auburn	Auburn	New York	United States	13021
452	Lincoln Medical and Mental Health Center	Bronx	New York	United States	10451
453	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
454	Mary Imogene Bassett Hospital	Cooperstown	New York	United States	13326
455	Hematology Oncology Associates of Central New York-East Syracuse	East Syracuse	New York	United States	13057
456	Elmhurst Hospital Center	Elmhurst	New York	United States	11373
457	Arnot Ogden Medical Center/Falck Cancer Center	Elmira	New York	United States	14905
458	Queens Hospital Center	Jamaica	New York	United States	11432
459	Orange Regional Medical Center	Middletown	New York	United States	10940
460	Columbia University/Herbert Irving Cancer Center	New York	New York	United States	10032
461	Highland Hospital	Rochester	New York	United States	14620
462	University of Rochester	Rochester	New York	United States	14642
463	Hematology Oncology Associates of Central New York-Rome	Rome	New York	United States	13440
464	Staten Island University Hospital	Staten Island	New York	United States	10305
465	State University of New York Upstate Medical University	Syracuse	New York	United States	13210
466	Hematology Oncology Associates of Central New York-Onondaga Hill	Syracuse	New York	United States	13215
467	Dickstein Cancer Treatment Center	White Plains	New York	United States	10601
468	Randolph Hospital	Asheboro	North Carolina	United States	27203
469	Cancer Care of Western North Carolina	Asheville	North Carolina	United States	28801
470	Mission Hospital-Memorial Campus	Asheville	North Carolina	United States	28801
471	Hope Women's Cancer Centers-Asheville	Asheville	North Carolina	United States	28816
472	Gaston Hematology and Oncology Associates-Belmont	Belmont	North Carolina	United States	28012
473	Southeastern Medical Oncology Center-Clinton	Clinton	North Carolina	United States	28328
474	CaroMont Regional Medical Center	Gastonia	North Carolina	United States	28054
475	Gaston Hematology and Oncology Associates	Gastonia	North Carolina	United States	28054
476	Southeastern Medical Oncology Center-Goldsboro	Goldsboro	North Carolina	United States	27534
477	Wayne Memorial Hospital	Goldsboro	North Carolina	United States	27534
478	Cone Health Cancer Center	Greensboro	North Carolina	United States	27403
479	Hendersonville Hematology and Oncology at Pardee	Hendersonville	North Carolina	United States	28791
480	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
481	Park Ridge Hospital Breast Health Center	Hendersonville	North Carolina	United States	28792
482	Southeastern Medical Oncology Center-Jacksonville	Jacksonville	North Carolina	United States	28546
483	Novant Health Oncology Specialists-Kernersville	Kernersville	North Carolina	United States	27284
484	Kinston Medical Specialists PA	Kinston	North Carolina	United States	28501
485	Cape Fear Cancer Specialists-Leland	Leland	North Carolina	United States	28451
486	Novant Health Oncology Specialists-Mount Airy	Mount Airy	North Carolina	United States	27030
487	FirstHealth of the Carolinas-Moore Regional Hosiptal	Pinehurst	North Carolina	United States	28374
488	Annie Penn Memorial Hospital	Reidsville	North Carolina	United States	27320
489	Carolina Oncology Associates PA	Salisbury	North Carolina	United States	28144
490	Cleveland Hematology and Oncology Associates PC	Shelby	North Carolina	United States	28150
491	Novant Health Oncology Specialists-Statesville	Statesville	North Carolina	United States	28625
492	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
493	Novant Health Oncology Specialists-Davidson County	Thomasville	North Carolina	United States	27360
494	Marion L Shepard Cancer Center at Vidant Beaufort Hospital	Washington	North Carolina	United States	27889
495	Novant Health Oncology Specialists-Wilkesboro	Wilkesboro	North Carolina	United States	28659
496	Cape Fear Cancer Specialists	Wilmington	North Carolina	United States	28401
497	New Hanover Regional Medical Center/Zimmer Cancer Center	Wilmington	North Carolina	United States	28401
498	Southeastern Medical Oncology Center-Wilson	Wilson	North Carolina	United States	27893
499	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
500	Novant Health Oncology Specialists	Winston-Salem	North Carolina	United States	27103
501	Winston-Salem Health Care	Winston-Salem	North Carolina	United States	27103
502	Southeast Clinical Oncology Research (SCOR) Consortium NCORP	Winston-Salem	North Carolina	United States	27104
503	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
504	Essentia Health Cancer Center-South University Clinic	Fargo	North Dakota	United States	58103
505	Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
506	Sanford Clinic North-Fargo	Fargo	North Dakota	United States	58122
507	Sanford Medical Center-Fargo	Fargo	North Dakota	United States	58122
508	Altru Cancer Center	Grand Forks	North Dakota	United States	58201
509	Trinity Cancer Care Center	Minot	North Dakota	United States	58701
510	Akron General Medical Center	Akron	Ohio	United States	44307
511	Strecker Cancer Center-Belpre	Belpre	Ohio	United States	45714
512	Toledo Clinic Cancer Centers-Bowling Green	Bowling Green	Ohio	United States	43402
513	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
514	Oncology Hematology Care Inc-Eden Park	Cincinnati	Ohio	United States	45202
515	Oncology Hematology Care Inc-Mercy West	Cincinnati	Ohio	United States	45211
516	Oncology Hematology Care Inc - Anderson	Cincinnati	Ohio	United States	45230
517	Oncology Hematology Care Inc-Kenwood	Cincinnati	Ohio	United States	45236
518	Oncology Hematology Care Inc-Blue Ash	Cincinnati	Ohio	United States	45242
519	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio	United States	43214
520	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
521	Columbus NCI Community Oncology Research Program	Columbus	Ohio	United States	43215
522	Grant Medical Center	Columbus	Ohio	United States	43215
523	The Mark H Zangmeister Center	Columbus	Ohio	United States	43219
524	Mount Carmel Health Center West	Columbus	Ohio	United States	43222
525	Doctors Hospital	Columbus	Ohio	United States	43228
526	Grandview Hospital	Dayton	Ohio	United States	45405
527	Good Samaritan Hospital - Dayton	Dayton	Ohio	United States	45406
528	Miami Valley Hospital	Dayton	Ohio	United States	45409
529	Samaritan North Health Center	Dayton	Ohio	United States	45415
530	Dayton NCI Community Oncology Research Program	Dayton	Ohio	United States	45420
531	Delaware Health Center-Grady Cancer Center	Delaware	Ohio	United States	43015
532	Delaware Radiation Oncology	Delaware	Ohio	United States	43015
533	Grady Memorial Hospital	Delaware	Ohio	United States	43015
534	Oncology Hematology Care Inc-Healthplex	Fairfield	Ohio	United States	45014
535	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
536	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
537	Wayne Hospital	Greenville	Ohio	United States	45331
538	Kettering Medical Center	Kettering	Ohio	United States	45429
539	Fairfield Medical Center	Lancaster	Ohio	United States	43130
540	Lancaster Radiation Oncology	Lancaster	Ohio	United States	43130
541	Saint Rita's Medical Center	Lima	Ohio	United States	45801
542	Lima Memorial Hospital	Lima	Ohio	United States	45804
543	Marietta Memorial Hospital	Marietta	Ohio	United States	45750
544	OneHealth Marion General Hospital	Marion	Ohio	United States	43302
545	Toledo Clinic Cancer Centers-Maumee	Maumee	Ohio	United States	43537
546	Toledo Radiation Oncology at Northwest Ohio Onocolgy Center	Maumee	Ohio	United States	43537
547	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
548	Licking Memorial Hospital	Newark	Ohio	United States	43055
549	Newark Radiation Oncology	Newark	Ohio	United States	43055
550	Saint Charles Hospital	Oregon	Ohio	United States	43616
551	Toledo Clinic Cancer Centers-Oregon	Oregon	Ohio	United States	43616
552	Southern Ohio Medical Center	Portsmouth	Ohio	United States	45662
553	Springfield Regional Medical Center	Springfield	Ohio	United States	45505
554	Flower Hospital	Sylvania	Ohio	United States	43560
555	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
556	The Toledo Hospital/Toledo Children's Hospital	Toledo	Ohio	United States	43606
557	Saint Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
558	University of Toledo	Toledo	Ohio	United States	43614
559	Toledo Community Hospital Oncology Program CCOP	Toledo	Ohio	United States	43617
560	Mercy Saint Anne Hospital	Toledo	Ohio	United States	43623
561	Toledo Clinic Cancer Centers-Toledo	Toledo	Ohio	United States	43623
562	Upper Valley Medical Center	Troy	Ohio	United States	45373
563	Fulton County Health Center	Wauseon	Ohio	United States	43567
564	Saint Ann's Hospital	Westerville	Ohio	United States	43081
565	Greene Memorial Hospital	Xenia	Ohio	United States	45385
566	Genesis Healthcare System Cancer Care Center	Zanesville	Ohio	United States	43701
567	Natalie Warren Bryant Cancer Center at Saint Francis	Tulsa	Oklahoma	United States	74136
568	Warren Clinic Oncology-Tulsa	Tulsa	Oklahoma	United States	74146
569	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
570	Good Samaritan Hospital	Corvallis	Oregon	United States	97330
571	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
572	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
573	Providence Willamette Falls Medical Center	Oregon City	Oregon	United States	97045
574	Providence Portland Medical Center	Portland	Oregon	United States	97213
575	Providence Saint Vincent Medical Center	Portland	Oregon	United States	97225
576	Kaiser Permanente Northwest	Portland	Oregon	United States	97227
577	Oregon Health and Science University	Portland	Oregon	United States	97239
578	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	United States	18103
579	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
580	Doylestown Hospital	Doylestown	Pennsylvania	United States	18901
581	Easton Hospital	Easton	Pennsylvania	United States	18042
582	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania	United States	18201
583	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
584	Geisinger Medical Oncology-Lewisburg	Lewisburg	Pennsylvania	United States	17837
585	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
586	Holy Redeemer Hospital and Medical Center	Meadowbrook	Pennsylvania	United States	19046
587	Phoenixville Hospital	Phoenixville	Pennsylvania	United States	19460
588	Pottstown Memorial Medical Center	Pottstown	Pennsylvania	United States	19464
589	Geisinger Medical Oncology-Pottsville	Pottsville	Pennsylvania	United States	17901
590	Geisinger Medical Group	State College	Pennsylvania	United States	16801
591	Chester County Hospital	West Chester	Pennsylvania	United States	19380
592	Reading Hospital	West Reading	Pennsylvania	United States	19611
593	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
594	Susquehanna Cancer Center	Williamsport	Pennsylvania	United States	17701
595	AnMed Health Cancer Center	Anderson	South Carolina	United States	29621
596	Beaufort Memorial Hospital	Beaufort	South Carolina	United States	29902
597	Roper Hospital	Charleston	South Carolina	United States	29401
598	Charleston Hematology Oncology Associates-Roper	Charleston	South Carolina	United States	29403
599	Lowcountry Hematology Oncology PA-North Charleston	Charleston	South Carolina	United States	29406
600	Charleston Hematology Oncology Associates PA-St. Francis	Charleston	South Carolina	United States	29414
601	Lowcountry Hematology Oncology PA-West Ashley	Charleston	South Carolina	United States	29414
602	Greenville Health System Cancer Institute-Easley	Easley	South Carolina	United States	29640
603	McLeod Regional Medical Center	Florence	South Carolina	United States	29506
604	Saint Francis Hospital	Greenville	South Carolina	United States	29601
605	Greenville Health System Cancer Institute-Andrews	Greenville	South Carolina	United States	29605
606	Greenville Health System Cancer Institute-Butternut	Greenville	South Carolina	United States	29605
607	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina	United States	29605
608	Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
609	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina	United States	29615
610	Self Regional Healthcare	Greenwood	South Carolina	United States	29646
611	Greenville Health System Cancer Institute-Greer	Greer	South Carolina	United States	29650
612	Gibbs Cancer Center-Pelham	Greer	South Carolina	United States	29651
613	Lowcountry Hematology Oncology PA-Mount Pleasant	Mount Pleasant	South Carolina	United States	29464
614	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina	United States	29672
615	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
616	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina	United States	29307
617	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
618	Sanford Cancer Center-Oncology Clinic	Sioux Falls	South Dakota	United States	57104
619	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
620	Boston Baskin Cancer Center-Bartlett	Bartlett	Tennessee	United States	38133
621	Baptist Memorial Hospital and Cancer Center-Memphis	Memphis	Tennessee	United States	38120
622	Family Cancer Center-Memphis	Memphis	Tennessee	United States	38120
623	The Don and Sybil Harrington Cancer Center	Amarillo	Texas	United States	79106
624	Texas Technology University	El Paso	Texas	United States	79905
625	Doctor's Hospital of Laredo	Laredo	Texas	United States	78041
626	American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	United States	84003
627	Sandra L Maxwell Cancer Center	Cedar City	Utah	United States	84720
628	Logan Regional Hospital	Logan	Utah	United States	84321
629	Intermountain Medical Center	Murray	Utah	United States	84107
630	McKay-Dee Hospital Center	Ogden	Utah	United States	84403
631	Utah Valley Regional Medical Center	Provo	Utah	United States	84604
632	Dixie Medical Center Regional Cancer Center	Saint George	Utah	United States	84770
633	Utah Cancer Specialists-Salt Lake City	Salt Lake City	Utah	United States	84106
634	LDS Hospital	Salt Lake City	Utah	United States	84143
635	Central Vermont Medical Center/National Life Cancer Treatment	Berlin	Vermont	United States	05602
636	University of Vermont College of Medicine	Burlington	Vermont	United States	05405
637	Kaiser Permanente-Burke Medical Center	Burke	Virginia	United States	22015
638	Sentara Martha Jefferson Hospital	Charlottesville	Virginia	United States	22901
639	IMG Hematology Oncology 8501	Fairfax	Virginia	United States	22031
640	Fredericksburg Oncology Inc	Fredericksburg	Virginia	United States	22401
641	Kaiser Permanente Tysons Corner Medical Center	McLean	Virginia	United States	22102
642	Bon Secours Saint Francis Medical Center	Midlothian	Virginia	United States	23114
643	Bon Secours Saint Mary's Hospital	Richmond	Virginia	United States	23226
644	Cancer Care Center at Island Hospital	Anacortes	Washington	United States	98221
645	MultiCare Auburn Medical Center	Auburn	Washington	United States	98001
646	Virginia Mason Bainbridge Island Medical Center	Bainbridge Island	Washington	United States	98110
647	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
648	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	United States	98225
649	Harrison HealthPartners Hematology and Oncology-Bremerton	Bremerton	Washington	United States	98310
650	Highline Medical Center-Main Campus	Burien	Washington	United States	98166
651	Swedish Medical Center-Edmonds	Edmonds	Washington	United States	98026
652	Virginia Mason Federal Way Medical Center	Federal Way	Washington	United States	98002
653	Tacoma/Valley Radiation Oncology Centers-Gig Harbor	Gig Harbor	Washington	United States	98332
654	MultiCare Gig Harbor Medical Park	Gig Harbor	Washington	United States	98335
655	Swedish Cancer Institute-Issaquah	Issaquah	Washington	United States	98029
656	Kadlec Clinic Hematology and Oncology	Kennewick	Washington	United States	99336
657	Northwest Cancer Clinic	Kennewick	Washington	United States	99336
658	PeaceHealth Saint John Medical Center	Longview	Washington	United States	98632
659	Virginia Mason Lynnwood Medical Center	Lynnwood	Washington	United States	98036
660	Skagit Valley Hospital	Mount Vernon	Washington	United States	98274
661	Harrison HealthPartners Hematology and Oncology-Poulsbo	Poulsbo	Washington	United States	98370
662	Peninsula Cancer Center	Poulsbo	Washington	United States	98370
663	MultiCare Good Samaritan Hospital	Puyallup	Washington	United States	98372
664	Tacoma/Valley Radiation Oncology Centers-Puyallup	Puyallup	Washington	United States	98372
665	Virginia Mason Medical Center	Seattle	Washington	United States	98101
666	Harborview Medical Center	Seattle	Washington	United States	98104
667	Minor and James Medical PLLC	Seattle	Washington	United States	98104
668	Swedish Medical Center-Ballard Campus	Seattle	Washington	United States	98107
669	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
670	Group Health Cooperative-Seattle	Seattle	Washington	United States	98112
671	Swedish Medical Center-First Hill	Seattle	Washington	United States	98122-4307
672	University of Washington Medical Center	Seattle	Washington	United States	98195
673	United General Hospital	Sedro-Woolley	Washington	United States	98284
674	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
675	Evergreen Hematology and Oncology PS	Spokane	Washington	United States	99218
676	Tacoma/Valley Radiation Oncology Centers-Jackson Hall	Tacoma	Washington	United States	97405
677	MultiCare Tacoma General Hospital	Tacoma	Washington	United States	98405
678	Northwest NCI Community Oncology Research Program	Tacoma	Washington	United States	98405
679	Tacoma/Valley Radiation Oncology Centers-Saint Joe's	Tacoma	Washington	United States	98405
680	PeaceHealth Southwest Medical Center	Vancouver	Washington	United States	98664
681	Compass Oncology Vancouver	Vancouver	Washington	United States	98684
682	Wenatchee Valley Hospital and Clinics	Wenatchee	Washington	United States	98801
683	Langlade Hospital and Cancer Center	Antigo	Wisconsin	United States	54409
684	Marshfield Clinic-Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
685	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin	United States	54701
686	Saint Agnes Hospital/Agnesian Cancer Center	Fond Du Lac	Wisconsin	United States	54935
687	Green Bay Oncology at Saint Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
688	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin	United States	54301
689	Green Bay Oncology Limited at Saint Mary's Hospital	Green Bay	Wisconsin	United States	54303
690	Saint Vincent Hospital Cancer Center at Saint Mary's	Green Bay	Wisconsin	United States	54303
691	Mercy Health System	Janesville	Wisconsin	United States	53547
692	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
693	Holy Family Memorial Hospital	Manitowoc	Wisconsin	United States	54221
694	Bay Area Medical Center	Marinette	Wisconsin	United States	54143
695	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
696	Wheaton Franciscan Healthcare - Saint Joseph	Milwaukee	Wisconsin	United States	53210
697	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
698	Cancer Center of Western Wisconsin	New Richmond	Wisconsin	United States	54017
699	Green Bay Oncology - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
700	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin	United States	54501
701	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin	United States	54868
702	HSHS Saint Nicholas Hospital	Sheboygan	Wisconsin	United States	53081
703	Marshfield Clinic Cancer Care at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
704	Green Bay Oncology - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
705	Aspirus Regional Cancer Center	Wausau	Wisconsin	United States	54401
706	Marshfield Clinic-Wausau Center	Wausau	Wisconsin	United States	54401
707	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
708	Aspirus UW Cancer Center	Wisconsin Rapids	Wisconsin	United States	54494
709	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
710	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
711	Cheyenne Regional Medical Center-West	Cheyenne	Wyoming	United States	82001
712	Big Horn Basin Cancer Center	Cody	Wyoming	United States	82414
713	Billings Clinic-Cody	Cody	Wyoming	United States	82414
714	Welch Cancer Center	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: N. Lynn Henry, MD, PhD, University of Michigan Rogel Cancer Center
• Study Chair: Anne F. Schott, MD, University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Dec 15, 2017

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT01598298
• Other Study ID Numbers: S1202; S1202; U10CA037429; NCI-2012-01960
• First Posted: May 15, 2012
• Last Update Posted: Jan 7, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Southwest Oncology Group: estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; pain; musculoskeletal complications
• Additional relevant MeSH terms: Breast Neoplasms; Duloxetine Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Arm I: Duloxetine	Arm II: Placebo
Arm/Group Description	Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Period Title: Overall Study
STARTED	150	149
Patients Evaluable for Primary Endpoint	127	128
Patients Evaluable for Adverse Events	138	141
COMPLETED	110	108
NOT COMPLETED	40	41

Baseline Characteristics

Arm/Group Title	Arm I: Duloxetine	Arm II: Placebo	Total
Arm/Group Description	Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO	Total of all reporting groups
Overall Participants	145	144	289
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60	60	60
Sex: Female, Male (Count of Participants)
Female	145 100%	144 100%	289 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 3.4%	6 4.2%	11 3.8%
Not Hispanic or Latino	140 96.6%	137 95.1%	277 95.8%
Unknown or Not Reported	0 0%	1 0.7%	1 0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 1.4%	2 0.7%
Asian	6 4.1%	3 2.1%	9 3.1%
Native Hawaiian or Other Pacific Islander	1 0.7%	0 0%	1 0.3%
Black or African American	10 6.9%	17 11.8%	27 9.3%
White	128 88.3%	120 83.3%	248 85.8%
More than one race	0 0%	1 0.7%	1 0.3%
Unknown or Not Reported	0 0%	1 0.7%	1 0.3%
Baseline pain score (Count of Participants)
4-6	110 75.9%	110 76.4%	220 76.1%
7-10	35 24.1%	34 23.6%	69 23.9%
Prior taxane use (Count of Participants)
No	68 46.9%	65 45.1%	133 46%
Yes	77 53.1%	79 54.9%	156 54%

Outcome Measures

1. Primary Outcome

Title	Average Joint Pain According to BPI-SF
Description	Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
Time Frame	Weeks 2, 6, 12, and 24; Week 12 reported

Outcome Measure Data

Analysis Population Description

Patients evaluable for primary endpoint

Arm/Group Title	Arm I: Duloxetine	Arm II: Placebo
Arm/Group Description	Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Measure Participants	127	128
Mean (Standard Deviation) [units on a scale]	2.9 (2.1)	3.5 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I: Duloxetine, Arm II: Placebo
	Comments	The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.
	Type of Statistical Test	Other
	Comments	Two-sided test at the alpha=0.05 level
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Two-sided p-value; alpha=0.05
	Method	Mixed Models Analysis
	Comments	Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)
Method of Estimation	Estimation Parameter	Coefficient for treatment term
	Estimated Value	-0.82
	Confidence Interval	(2-Sided) 95%; -1.24 to -0.40
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.

2. Secondary Outcome

Title	Worst Joint Pain According to the BPI-SF
Description	Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
Time Frame	Weeks 2, 6, 12, and 24; Week 12 reported

Outcome Measure Data

Analysis Population Description

Patients evaluable for primary endpoint

Arm/Group Title	Arm I: Duloxetine	Arm II: Placebo
Arm/Group Description	Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Measure Participants	127	128
Mean (Standard Deviation) [units on a scale]	4.0 (2.8)	4.9 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I: Duloxetine, Arm II: Placebo
	Comments	The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.
	Type of Statistical Test	Other
	Comments	Two-sided test at the alpha=0.05 level
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two-sided p-value; alpha=0.05
	Method	Mixed Models Analysis
	Comments	Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).
Method of Estimation	Estimation Parameter	Coefficient for treatment term
	Estimated Value	-1.06
	Confidence Interval	(2-Sided) 95%; -1.57 to -0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.

3. Secondary Outcome

Title	Pain Interference According to the BPI-SF
Description	Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating "Does not interfere" and 10 indicating "Completely interferes".
Time Frame	Weeks 2, 6, 12, and 24; Week 12 reported

Outcome Measure Data

Analysis Population Description

Patients evaluable for primary endpoint

Arm/Group Title	Arm I: Duloxetine	Arm II: Placebo
Arm/Group Description	Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Measure Participants	127	128
Mean (Standard Deviation) [units on a scale]	1.9 (2.2)	2.6 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I: Duloxetine, Arm II: Placebo
	Comments	The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.
	Type of Statistical Test	Other
	Comments	Two-sided test at the alpha=0.05 level
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two-sided p-value; alpha=0.05
	Method	Mixed Models Analysis
	Comments	Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).
Method of Estimation	Estimation Parameter	Coefficient fro treatment term
	Estimated Value	-0.95
	Confidence Interval	(2-Sided) 95%; -1.35 to -0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.

Adverse Events

Time Frame	Up to 24 weeks
Adverse Event Reporting Description	Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Arm/Group Title	Arm II: Placebo		Arm I: Duloxetine
Arm/Group Description	Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO		Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO
All Cause Mortality
	Arm II: Placebo		Arm I: Duloxetine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0%)		0/138 (0%)
Serious Adverse Events
	Arm II: Placebo		Arm I: Duloxetine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0%)		0/138 (0%)
Other (Not Including Serious) Adverse Events
	Arm II: Placebo		Arm I: Duloxetine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	83/141 (58.9%)		115/138 (83.3%)
Ear and labyrinth disorders
Vertigo	6/141 (4.3%)		10/138 (7.2%)
Gastrointestinal disorders
Abdominal pain	6/141 (4.3%)		11/138 (8%)
Constipation	9/141 (6.4%)		23/138 (16.7%)
Diarrhea	10/141 (7.1%)		21/138 (15.2%)
Dry mouth	20/141 (14.2%)		38/138 (27.5%)
Nausea	12/141 (8.5%)		47/138 (34.1%)
Vomiting	2/141 (1.4%)		7/138 (5.1%)
General disorders
Fatigue	25/141 (17.7%)		52/138 (37.7%)
Flu like symptoms	1/141 (0.7%)		12/138 (8.7%)
Pain	23/141 (16.3%)		27/138 (19.6%)
Metabolism and nutrition disorders
Anorexia	3/141 (2.1%)		13/138 (9.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	26/141 (18.4%)		31/138 (22.5%)
Joint range of motion decreased	13/141 (9.2%)		15/138 (10.9%)
Myalgia	18/141 (12.8%)		32/138 (23.2%)
Pain in extremity	5/141 (3.5%)		8/138 (5.8%)
Nervous system disorders
Dizziness	5/141 (3.5%)		20/138 (14.5%)
Headache	30/141 (21.3%)		35/138 (25.4%)
Lethargy	1/141 (0.7%)		9/138 (6.5%)
Paresthesia	10/141 (7.1%)		7/138 (5.1%)
Somnolence	4/141 (2.8%)		14/138 (10.1%)
Tremor	0/141 (0%)		11/138 (8%)
Psychiatric disorders
Agitation	7/141 (5%)		10/138 (7.2%)
Insomnia	12/141 (8.5%)		22/138 (15.9%)
Respiratory, thoracic and mediastinal disorders
Cough	6/141 (4.3%)		8/138 (5.8%)
Nasal congestion	8/141 (5.7%)		7/138 (5.1%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	5/141 (3.5%)		13/138 (9.4%)
Vascular disorders
Hot flashes	22/141 (15.6%)		33/138 (23.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.