S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer
Sponsor
Southwest Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT02137837
Collaborator
AstraZeneca (Industry), Novartis (Industry)
37
223
3
68
0.2
0
Study Details
Study Description
Brief Summary
This randomized Phase III trial studies how well the combination of fulvestrant and everolimus together or the combination of anastrozole, fulvestrant and everolimus together, improve progression-free survival (PFS) versus fulvestrant alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
Primary
-
To test the benefit of interfering with the function of the estrogen receptor (ER) and providing downstream target inhibition (PI3K/AKT/mTOR) with a combination of optimal dose fulvestrant and everolimus (Arm 2) to improve progression-free survival compared to the optimal dose fulvestrant alone (Arm 1).
-
To test the benefit of adding the non-steroidal aromatase inhibitor anastrozole to optimal dose fulvestrant and everolimus (Arm 3) in order to improve progression free survival over optimal dose fulvestrant (Arm 1).
Secondary
-
To compare progression-free survival among those receiving fulvestrant + everolimus + anastrozole (Arm 3) versus fulvestrant + everolimus (Arm 2).
-
To compare overall survival among the treatment arms in post-menopausal patients with hormone-receptor positive (HR+) Stage IV breast cancer.
-
To assess and compare toxicities, feasibility and compliance among the study regimens.
-
To compare response rates and clinical benefit rates among the study regimens.
-
To test molecular determinants of response to endocrine therapy and everolimus in circulating tumor cells:
-
CTC-Endocrine Therapy Index (CTC ETI) on the CellSearch® platform.
-
CTC-Next Generation Sequencing Analysis (CTC-NGS) of single cells captured on the HD-CTC® platform.
OUTLINE:
This is a multicenter study. Patients will be stratified according to the following factors:
-
Measurable versus evaluable non-measurable disease
-
Prior adjuvant hormonal therapy completed more than 5 years ago vs. prior adjuvant hormonal therapy completed 1-5 years ago vs. de novo presentation of metastatic disease or no prior adjuvant hormonal therapy.
ARMS:
-
Arm 1: fulvestrant + placebo (everolimus) + placebo (anastrozole)
-
Arm 2: fulvestrant + everolimus + placebo (anastrozole)
-
Arm 3: fulvestrant + everolimus + anastrozole
Blood and tissue samples are collected for correlative science studies.
After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients
Study Start Date
:
May 1, 2014
Actual Primary Completion Date
:
Dec 31, 2019
Actual Study Completion Date
:
Dec 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Arm 1: fulvestrant + everolimus placebo + anastrozole placebo Patients receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. |
Drug: Fulvestrant
Other Names:
Drug: Placebo - Anastrozole
Drug: Placebo - Everolimus
|
| Experimental: Arm 2: fulvestrant + everolimus + anastrozole placebo Patients receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. |
Drug: Fulvestrant
Other Names:
Drug: Everolimus
Other Names:
Drug: Placebo - Anastrozole
|
| Experimental: Arm 3: fulvestrant + everolimus + anastrozole Patients receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. |
Drug: Fulvestrant
Other Names:
Drug: Anastrozole
Other Names:
Drug: Everolimus
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus ) [up to 5 years]
From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive are censored at date of last contact.
- Progression-free Survival (Fulvestrant Versus Fulvestrant + Everolimus + Anastrozole) [up to 5 years]
From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
Secondary Outcome Measures
- Progression Free Survival (Fulvestrant + Everolimus vs Fulvestrant + Everolimus + Anastrozole) [up to 5 years]
From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
- Overall Survival [up to 5 years]
From date of registration to date of death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
- Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs [Duration of treatment and follow up until death or 5 years post registration]
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
- Response Rate [assessed every 12 weeks, up to 5 years]
Proportion of participants who have confirmed or unconfirmed partial or complete response to therapy
- Clinical Benefit Rate [assessed every 12 weeks, up to 5 years]
Proportion of participants who have confirmed and unconfirmed partial response, complete response or stable disease.
- Molecular Determinants of Response in Circulating Tumor Cells: CTC-ETI [Day 1, Day 29, time of progression (Day 29 to be collected only if Day 1 CTC was elevated.)]
CTC-Endocrine Therapy Index (CTC-ETI) on the CellSearch® platform. Based on enumeration of CTC/7.5 mL of whole blood, with >= 5 being elevated. (Due to limited samples collected, full analysis was not able to be performed as planned, so outcome measure reported here is number with elevated Day 1 CTC.)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
-
Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative human epidermal growth factor receptor (HER-2), for whom endocrine therapy is planned.
-
The HER-2 test result is negative (and should be reported as such), if a single test (or all tests)performed in a tumor specimen show:
-
Immunohistochemistries (IHC) 1+ negative or IHC 0 negative or
-
in situ hybridization (ISH) negative using a single probe ISH or dual probe ISH.
-
Estrogen receptor (ER) and progesterone receptor (PgR) positivity must be assessed according to American Society of Clinial Oncology (ASCO)/College of American Physicians (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining. If HER2 IHC is 2+, an evaluation for gene amplification must be performed and the gene must not be amplified. Gene amplification evaluation is not required if evaluation by IHC is 0 or 1+ by institutional standards.
-
Patients must be post-menopausal women with a confirmed diagnosis of metastatic breast cancer (M1). Pathologic confirmation of histology is preferable. In the case of bone metastases only, biopsy-proven metastatic disease of solitary site, or multiple sites of involvement are required. Post-menopausal is defined by one of the following criteria as per National Comprehensive Cancer Network (NCCN) guidelines Version 3. 2013:
-
Prior bilateral oophorectomy and/or hysterectomy
-
Patients ≥ 60 years of age
-
Patients < 60 years of age and amenorrheic for ≥ 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone (FSH) and estradiol in the post-menopausal range
-
Patients < 60 years of age taking tamoxifen or toremifene must have FSH and plasma estradiol levels within post-menopausal ranges
-
Patients must have measurable or evaluable disease. Patients must have a chest and abdominal computerized tomography (CT) and bone scan within 28 days prior to registration. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Evaluable disease must be assessed within 28 days prior to registration
-
Patients with a history of prior chemotherapy or hormone therapy or immunotherapy for recurrent or metastatic disease are NOT eligible. Prior adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to registration is acceptable. Any number of prior hormonal therapy regimens for the adjuvant setting but not for metastatic or recurrent disease is allowed; prior adjuvant or neoadjuvant treatment with an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane) is allowed, if completed more than 12 months prior to randomization.
-
Patients who have taken luteinizing hormone-releasing hormone (LHRH) analogue as adjuvant therapy are eligible provided they have a) discontinued such therapy at least 12 months prior to registration AND b) have not resumed their menstrual periods.
-
Patients must not have had prior exposure to fulvestrant or mTOR inhibitors (e.g., rapamycin, everolimus, temsirolimus, deforolimus). Concurrent bisphosphonate therapy is allowed. Patients must not have prior treatment with any investigational drug within 28 days prior to registration and must not be planning to receive any other investigational drug for the duration of the study.
-
Patients must have an International Normalized Ratio (INR) ≤ 1.6 within 28 days prior to registration.
-
Patients must have adequate bone marrow function, as defined by Absolute Neutrophil Count (ANC) of ≥ 1,500/mL, hemoglobin ≥ 9 g/dL and a peripheral platelet count ≥ 100,000/ mL, all within 28 days prior to registration.
-
Patients must have adequate hepatic function obtained within 28 days prior to registration and documented by all of the following:
-
Bilirubin ≤ 1.5 mg/dL (or ≤ 3.0 mg/dL if due to Gilbert's Syndrome)
-
alanine aminotransferase (ALT) (SGPT) and aspartate aminotransferase (AST) (SGOT) ≤ 2.5 x Institutional Upper Limit of Normal (IULN), or ≤ 5 x IULN if hepatic metastases are present.
-
Patients must have adequate renal function with serum creatinine level ≤ IULN within 28 days prior to registration.
-
Patients must have a fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 x IULN obtained within 28 days prior to registration. Patients may be on lipid lowering agents to reach these values.
-
Patients must have a complete history and physical examination within 28 days prior to registration.
-
Patients with bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or long-term anti-coagulant therapy (other than antiplatelet therapy) are NOT eligible.
-
Patients with presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread are not eligible. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease in the opinion of the investigator.
-
Patients must have a performance status of 0 - 2 by Zubrod criteria.
-
Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
-
Patients must not have uncontrolled diabetes (defined as an Hg A1C >7% within 28 days prior to registration).
-
Patients must not have an organ allograft or other history of immune compromise. Patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
-
Patients known to be HIV positive may be enrolled if baseline CD4 count is > 500 cells/mm3 AND not taking anti-retroviral therapy. Patients with known chronic or active hepatitis are not eligible. Patients must not have any known uncontrolled underlying pulmonary disease.
-
Patients must be able to take oral medications. Patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
-
Patients must not have received immunization with an attenuated live vaccine (e.g. intranasal influenza, MMR, oral polio, varicella, zoster, yellow fever and BCG vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment.
-
Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors, and/or CYP3A4 inducers.
-
No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Breast Care and Surgery LLC | Anchorage | Alaska | United States | 99508 |
| 2 | Alaska Women's Cancer Care | Anchorage | Alaska | United States | 99508 |
| 3 | Anchorage Oncology Centre | Anchorage | Alaska | United States | 99508 |
| 4 | Katmai Oncology Group | Anchorage | Alaska | United States | 99508 |
| 5 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 6 | Virginia G. Piper Cancer Center | Scottsdale | Arizona | United States | 85258 |
| 7 | University of Arizona Cancer Center - Orange Grove | Tucson | Arizona | United States | 85704 |
| 8 | University of Arizona Cancer Center - North Campus | Tucson | Arizona | United States | 85719 |
| 9 | Southern Arizona VA Health Care System | Tucson | Arizona | United States | 85723 |
| 10 | University of Arizona Medical Center - Univ Campus | Tucson | Arizona | United States | 85724 |
| 11 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 12 | Providence St. Joseph Medical Ctr/Disney Family CC | Burbank | California | United States | 91505 |
| 13 | City of Hope-Corona | Corona | California | United States | 92879 |
| 14 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
| 15 | City of Hope Antelope Valley | Lancaster | California | United States | 93534 |
| 16 | Bay Area Tumor Institute | Oakland | California | United States | 94609 |
| 17 | Summit Medical Center | Oakland | California | United States | 94609 |
| 18 | Epic Care - Oakland | Oakland | California | United States | 94612 |
| 19 | City of Hope South Pasadena | South Pasadena | California | United States | 91030 |
| 20 | Bridgeport Hospital | Bridgeport | Connecticut | United States | 06610 |
| 21 | St. Francis Hospital and Medical Center | Hartford | Connecticut | United States | 06105 |
| 22 | Yale University | New Haven | Connecticut | United States | 06520 |
| 23 | Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut | United States | 06473 |
| 24 | Sacred Heart Hospital | Pensacola | Florida | United States | 32504 |
| 25 | Cleveland Clinic - Weston | Weston | Florida | United States | 33331 |
| 26 | South Georgia Medical Center - Pearlman Cancer Ctr | Valdosta | Georgia | United States | 31602 |
| 27 | Oncare Hawaii, Inc - Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 28 | Pali Momi Medical Center | 'Aiea | Hawaii | United States | 96701 |
| 29 | Oncare Hawaii Inc-POB I | Honolulu | Hawaii | United States | 96813 |
| 30 | Oncare Hawaii, Inc - POB II | Honolulu | Hawaii | United States | 96813 |
| 31 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813 |
| 32 | University of Hawaii Cancer Center | Honolulu | Hawaii | United States | 96813 |
| 33 | Oncare Hawaii, Inc - Kuakini | Honolulu | Hawaii | United States | 96817 |
| 34 | Oncare Hawaii, Inc - Liliha | Honolulu | Hawaii | United States | 96817 |
| 35 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 36 | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii | United States | 96766 |
| 37 | St. Alphonsus Regional Medical Center | Boise | Idaho | United States | 83706 |
| 38 | Kootenai Medical Center | Coeur d'Alene | Idaho | United States | 83814 |
| 39 | Kootenai Cancer Center | Post Falls | Idaho | United States | 83854 |
| 40 | Kootenai Cancer Clinic | Sandpoint | Idaho | United States | 83864 |
| 41 | Centralia Oncology Clinic | Centralia | Illinois | United States | 62801 |
| 42 | Cancer Care Specialists of Central Illinois | Decatur | Illinois | United States | 62526 |
| 43 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 44 | Heartland Cancer Research NCORP | Decatur | Illinois | United States | 62526 |
| 45 | Kishwaukee Community Hospital | DeKalb | Illinois | United States | 60115 |
| 46 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 47 | Loyola University Stritch School of Medicine | Maywood | Illinois | United States | 60153 |
| 48 | Marjorie Weinberg Cancer Center | Melrose Park | Illinois | United States | 60160 |
| 49 | Good Samaritan Regional Health Center | Mount Vernon | Illinois | United States | 62864 |
| 50 | Central Illinois Hematology Oncology Center | Springfield | Illinois | United States | 62702 |
| 51 | Springfield Clinic | Springfield | Illinois | United States | 62703 |
| 52 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 53 | Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois | United States | 62226 |
| 54 | Reid Hospital and Health Care Services | Richmond | Indiana | United States | 47374 |
| 55 | Cancer Center of Kansas - Chanute | Chanute | Kansas | United States | 66720 |
| 56 | Cancer Center of Kansas - Dodge City | Dodge City | Kansas | United States | 67801 |
| 57 | Cancer Center of Kansas - El Dorado | El Dorado | Kansas | United States | 67042 |
| 58 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
| 59 | Cancer Center of Kansas - Independence | Independence | Kansas | United States | 67301 |
| 60 | Cancer Center of Kansas - Kingman | Kingman | Kansas | United States | 67068 |
| 61 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
| 62 | Cancer Center of Kansas - Liberal | Liberal | Kansas | United States | 67901 |
| 63 | Cancer Center of Kansas - Newton | Newton | Kansas | United States | 67114 |
| 64 | Cancer Center of Kansas - Parsons | Parsons | Kansas | United States | 67357 |
| 65 | Cancer Center of Kansas - Pratt | Pratt | Kansas | United States | 67124 |
| 66 | Cancer Center of Kansas - Salina | Salina | Kansas | United States | 67401 |
| 67 | Cancer Center of Kansas - Wellington | Wellington | Kansas | United States | 67152 |
| 68 | Associates in Women's Health | Wichita | Kansas | United States | 67208 |
| 69 | Cancer Center of Kansas - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 70 | Cancer Center of Kansas - Wichita | Wichita | Kansas | United States | 67214 |
| 71 | Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
| 72 | Wichita NCI Community Oncology Research Program | Wichita | Kansas | United States | 67214 |
| 73 | Cancer Center of Kansas - Winfield | Winfield | Kansas | United States | 67156 |
| 74 | De Soto Regional Medical Center | Mansfield | Louisiana | United States | 71052 |
| 75 | University Health Conway | Monroe | Louisiana | United States | 71210 |
| 76 | Highland Clinic | Shreveport | Louisiana | United States | 71105 |
| 77 | Louisiana State University Health Sciences Center | Shreveport | Louisiana | United States | 71130 |
| 78 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 79 | Beverly Hospital | Beverly | Massachusetts | United States | 01915 |
| 80 | Lahey Hospital and Medical Center | Burlington | Massachusetts | United States | 01805 |
| 81 | Addison Gilbert Hospital | Gloucester | Massachusetts | United States | 01930 |
| 82 | Winchester Hospital | Winchester | Massachusetts | United States | 01890 |
| 83 | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | United States | 48106 |
| 84 | St. Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 85 | University of Michigan Medical Center | Ann Arbor | Michigan | United States | 48109 |
| 86 | Oakwood Healthcare, Inc. | Dearborn | Michigan | United States | 48123 |
| 87 | Wayne State University Medical Center | Detroit | Michigan | United States | 48202 |
| 88 | St. John Hospital and Medical Center | Detroit | Michigan | United States | 48236 |
| 89 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 90 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 91 | William Beaumont Hospital-Grosse Pointe | Grosse Pointe | Michigan | United States | 48230 |
| 92 | Allegiance Health | Jackson | Michigan | United States | 49201 |
| 93 | Sparrow Health System | Lansing | Michigan | United States | 48909 |
| 94 | St. Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
| 95 | MidMichigan Medical Center - Midland | Midland | Michigan | United States | 48670 |
| 96 | St Joseph Mercy Hospital - Oakland | Pontiac | Michigan | United States | 48341 |
| 97 | St. Joseph Mercy Port Huron | Port Huron | Michigan | United States | 48060 |
| 98 | Beaumont Children's Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 99 | Beaumont NCI Community Oncology Research Program | Royal Oak | Michigan | United States | 48073 |
| 100 | St. Mary's Health System | Saginaw | Michigan | United States | 48601 |
| 101 | Beaumont Hospital, Troy Campus | Troy | Michigan | United States | 48085 |
| 102 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
| 103 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 104 | Central Care Cancer Ctr-Carrie J. Babb Cancer Ctr | Bolivar | Missouri | United States | 65613 |
| 105 | Cox Cancer Center Branson | Branson | Missouri | United States | 65616 |
| 106 | St. Francis Medical Center | Cape Girardeau | Missouri | United States | 63701 |
| 107 | Mercy Hospital - Joplin | Joplin | Missouri | United States | 64804 |
| 108 | Mercy Clinic Care and Hematology - Rolla | Rolla | Missouri | United States | 65401 |
| 109 | PCRMC Bond Clinic | Rolla | Missouri | United States | 65401 |
| 110 | Phelps County Regional Medical Center | Rolla | Missouri | United States | 65401 |
| 111 | St. Louis Cancer and Breast Institute-South City | Saint Louis | Missouri | United States | 63109 |
| 112 | Christian Hospital | Saint Louis | Missouri | United States | 63136 |
| 113 | Mercy Hospital St. Louis | Saint Louis | Missouri | United States | 63141 |
| 114 | Cancer Research for the Ozarks NCORP | Springfield | Missouri | United States | 65804 |
| 115 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
| 116 | CoxHealth South Hospital | Springfield | Missouri | United States | 65807 |
| 117 | Mercy Hospital Washington | Washington | Missouri | United States | 63090 |
| 118 | Montana Cancer Consortium NCORP | Billings | Montana | United States | 59101 |
| 119 | Billings Clinic Cancer Center | Billings | Montana | United States | 59107 |
| 120 | Bozeman Deaconess Hospital | Bozeman | Montana | United States | 59715 |
| 121 | St. James Community Hosp and Cancer Treatment Center | Butte | Montana | United States | 59702 |
| 122 | Benefis Healthcare West Campus | Great Falls | Montana | United States | 59405 |
| 123 | St. Peter's Community Hospital | Helena | Montana | United States | 59601 |
| 124 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
| 125 | Community Medical Center | Missoula | Montana | United States | 59801 |
| 126 | St. Patrick Hospital | Missoula | Montana | United States | 59806 |
| 127 | CHI Health Good Samaritan Hospital | Kearney | Nebraska | United States | 68847 |
| 128 | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | United States | 28328 |
| 129 | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | United States | 27534 |
| 130 | Wayne Memorial Hospital | Goldsboro | North Carolina | United States | 27534 |
| 131 | Hendersonville Hematology and Oncology at Pardee | Hendersonville | North Carolina | United States | 28739 |
| 132 | Margaret R. Pardee Memorial Hospital | Hendersonville | North Carolina | United States | 28791 |
| 133 | Park Ridge Health | Hendersonville | North Carolina | United States | 28792 |
| 134 | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | United States | 28546 |
| 135 | Southeastern Medical Oncology Center-Wilson | Wilson | North Carolina | United States | 27893 |
| 136 | Wilson Medical Center | Wilson | North Carolina | United States | 27893 |
| 137 | Cleveland Clinic Cancer Center - Beachwood | Beachwood | Ohio | United States | 44122 |
| 138 | Strecker Cancer Center-Belpre | Belpre | Ohio | United States | 45714 |
| 139 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
| 140 | VA Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 141 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45267 |
| 142 | Cleveland Clinic Cancer Center - Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 143 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 144 | Mount Carmel East Hospital | Columbus | Ohio | United States | 43213 |
| 145 | Columbus NCI Community Oncology Research Program | Columbus | Ohio | United States | 43215 |
| 146 | The Mark H. Zangmeister Center | Columbus | Ohio | United States | 43219 |
| 147 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
| 148 | Good Samaritan Hospital and Health Center | Dayton | Ohio | United States | 45406 |
| 149 | Samaritan North Health Center | Dayton | Ohio | United States | 45415 |
| 150 | Dayton NCI Community Oncology Research Program | Dayton | Ohio | United States | 45420 |
| 151 | VA Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
| 152 | Wayne Hospital | Greenville | Ohio | United States | 45331 |
| 153 | Cleveland Clinic Cancer Center - Independence | Independence | Ohio | United States | 44131 |
| 154 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
| 155 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
| 156 | Cleveland Clinic Cancer Center - Mansfield | Mansfield | Ohio | United States | 44906 |
| 157 | Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
| 158 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
| 159 | Knox Community Hospital | Mount Vernon | Ohio | United States | 43050 |
| 160 | Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
| 161 | Southern Ohio Medical Center | Portsmouth | Ohio | United States | 45662 |
| 162 | North Coast Cancer Care, Inc. | Sandusky | Ohio | United States | 44870 |
| 163 | Springfield Regional Medical Center | Springfield | Ohio | United States | 45501 |
| 164 | Springfield Regional Cancer Center | Springfield | Ohio | United States | 45504 |
| 165 | Cleveland Clinic Strongsville Family Health Center | Strongsville | Ohio | United States | 44136 |
| 166 | Upper Valley Medical Centers | Troy | Ohio | United States | 45373 |
| 167 | South Pointe Hospital | Warrensville Heights | Ohio | United States | 44122 |
| 168 | St. Ann's Hospital | Westerville | Ohio | United States | 43081 |
| 169 | Cleveland Clinic Cancer Center - Wooster | Wooster | Ohio | United States | 44691 |
| 170 | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | United States | 43701 |
| 171 | St. Charles Health System | Bend | Oregon | United States | 97701 |
| 172 | Clackamas Radiation Oncology Center | Clackamas | Oregon | United States | 97015 |
| 173 | Providence Oncology and Hematology Care Southeast | Clackamas | Oregon | United States | 97015 |
| 174 | Providence Newberg Medical Center | Newberg | Oregon | United States | 97132 |
| 175 | Providence Willamette Falls Medical Center | Oregon City | Oregon | United States | 97045 |
| 176 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 177 | Providence St. Vincent Medical Center | Portland | Oregon | United States | 97225 |
| 178 | McLeod Regional Medical Center | Florence | South Carolina | United States | 29501 |
| 179 | Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | United States | 29341 |
| 180 | Gibbs Cancer Center-Pelham | Greer | South Carolina | United States | 29651 |
| 181 | Spartanburg Medical Cancer | Spartanburg | South Carolina | United States | 29303 |
| 182 | MGC Hematology Oncology-Union | Union | South Carolina | United States | 29379 |
| 183 | Wellmont Bristol Regional Medical Center | Bristol | Tennessee | United States | 37620 |
| 184 | Wellmont Medical Associates Oncology and Hematology | Bristol | Tennessee | United States | 37620 |
| 185 | Wellmont Medical Assoc Onc and Hem-Johnson City | Johnson City | Tennessee | United States | 37604 |
| 186 | Holston Valley Hospital and Medical Center | Kingsport | Tennessee | United States | 37660 |
| 187 | Wellmont Medical Assoc Onc and Hem-Kingsport | Kingsport | Tennessee | United States | 37660 |
| 188 | Thompson Cancer Survival Center | Knoxville | Tennessee | United States | 37916 |
| 189 | Don and Sybil Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 190 | University of Utah Medical Center | Salt Lake City | Utah | United States | 84132 |
| 191 | Southwest Virginia Cancer Center | Norton | Virginia | United States | 24273 |
| 192 | Island Hospital | Anacortes | Washington | United States | 98221 |
| 193 | Auburn Regional Medical Center | Auburn | Washington | United States | 98001 |
| 194 | Virginia Mason Bainbridge Island Medical Center | Bainbridge Island | Washington | United States | 98110 |
| 195 | Overlake Hospital Medical Center | Bellevue | Washington | United States | 98004 |
| 196 | Swedish Cancer Inst-Eastside Oncology Hematoly | Bellevue | Washington | United States | 98005 |
| 197 | PeaceHealth St. Joseph Medical Center | Bellingham | Washington | United States | 98225 |
| 198 | Swedish Medical Center - Edmonds | Edmonds | Washington | United States | 98026 |
| 199 | Virginia Mason Federal Way Medical Center | Federal Way | Washington | United States | 98002 |
| 200 | Tacoma/Valley Radiation Oncology Ctrs-Gig Harbor | Gig Harbor | Washington | United States | 98332 |
| 201 | MultiCare Gig Harbor Medical Park | Gig Harbor | Washington | United States | 98335 |
| 202 | Swedish Cancer Institute-Issaquah | Issaquah | Washington | United States | 98029 |
| 203 | PeaceHealth St. John Medical Center | Longview | Washington | United States | 98632 |
| 204 | Virginia Mason Lynnwood Medical Center | Lynnwood | Washington | United States | 98036 |
| 205 | MultiCare Good Samaritan Hospital | Puyallup | Washington | United States | 98372 |
| 206 | Tacoma/Valley Radiation Oncology Ctrs-Puyallup | Puyallup | Washington | United States | 98372 |
| 207 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 208 | Minor and James Medical, PLLC | Seattle | Washington | United States | 98104 |
| 209 | Pacific Cancer Research Consortium NCORP | Seattle | Washington | United States | 98104 |
| 210 | Pacific Medical Center - First Hill | Seattle | Washington | United States | 98104 |
| 211 | Swedish Medical Center | Seattle | Washington | United States | 98104 |
| 212 | Swedish Medical Center - Ballard Campus | Seattle | Washington | United States | 98107 |
| 213 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
| 214 | Group Health Cooperative-Seattle | Seattle | Washington | United States | 98112 |
| 215 | Tacoma/Valley Radiation Oncology Ctrs-Jackson Hill | Tacoma | Washington | United States | 97405 |
| 216 | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | United States | 98405 |
| 217 | MultiCare Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 218 | Northwest NCI Community Oncology Research Program | Tacoma | Washington | United States | 98405 |
| 219 | Tacoma/Valley Radiation Oncology Ctrs-Saint Joe's | Tacoma | Washington | United States | 98405 |
| 220 | Multicare Health System | Tacoma | Washington | United States | 98415 |
| 221 | PeaceHealth Southwest Medical Center | Vancouver | Washington | United States | 98668 |
| 222 | Billings Clinic-Cody | Cody | Wyoming | United States | 82414 |
| 223 | Welch Cancer Center - Sheridan Memorial Hospital | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- Southwest Oncology Group
- AstraZeneca
- Novartis
Investigators
- Study Chair: Halle Moore, M.D., The Cleveland Clinic
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT02137837
Other Study ID Numbers:
- S1222
First Posted:
May 14, 2014
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Anastrozole Everolimus |
| Period Title: Overall Study | |||
| STARTED | 13 | 12 | 12 |
| Received Protocol Therapy | 13 | 11 | 12 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 13 | 12 | 12 |
Baseline Characteristics
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Anastrozole Everolimus | Total of all reporting groups |
| Overall Participants | 13 | 12 | 12 | 37 |
| Age (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
63.4
|
62.6
|
60.5
|
62.0
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
13
100%
|
12
100%
|
12
100%
|
37
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
1
7.7%
|
2
16.7%
|
0
0%
|
3
8.1%
|
| Not Hispanic or Latino |
12
92.3%
|
10
83.3%
|
12
100%
|
34
91.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
8.3%
|
0
0%
|
1
2.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
15.4%
|
0
0%
|
3
25%
|
5
13.5%
|
| White |
9
69.2%
|
10
83.3%
|
9
75%
|
28
75.7%
|
| More than one race |
1
7.7%
|
0
0%
|
0
0%
|
1
2.7%
|
| Unknown or Not Reported |
1
7.7%
|
1
8.3%
|
0
0%
|
2
5.4%
|
| Disease (participants) [Number] | ||||
| Measurable |
9
69.2%
|
10
83.3%
|
9
75%
|
28
75.7%
|
| Evaluable non-measurable disease |
4
30.8%
|
2
16.7%
|
3
25%
|
9
24.3%
|
| Prior Hormone (Count of Participants) | ||||
| Prior adjuvant hormonal therapy completed >5 years ago |
3
23.1%
|
1
8.3%
|
2
16.7%
|
6
16.2%
|
| Prior adjuvant hormonal therapy completed 1-5 years ago |
4
30.8%
|
5
41.7%
|
6
50%
|
15
40.5%
|
| De novo presentation of metastatic disease or no prior adjuvant hormonal therapy |
6
46.2%
|
6
50%
|
4
33.3%
|
16
43.2%
|
Outcome Measures
| Title | Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus ) |
|---|---|
| Description | From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive are censored at date of last contact. |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment. |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo |
|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.) Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.) Fulvestrant Everolimus Placebo - Anastrozole |
| Measure Participants | 13 | 12 |
| Median (95% Confidence Interval) [months] |
14.0
|
11.3
|
| Title | Progression-free Survival (Fulvestrant Versus Fulvestrant + Everolimus + Anastrozole) |
|---|---|
| Description | From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact. |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants who were randomized to study arms and received protocol therapy |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.) Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.) Fulvestrant Anastrozole Everolimus |
| Measure Participants | 13 | 12 |
| Median (95% Confidence Interval) [months] |
14.0
|
9.9
|
| Title | Progression Free Survival (Fulvestrant + Everolimus vs Fulvestrant + Everolimus + Anastrozole) |
|---|---|
| Description | From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact. |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment. |
| Arm/Group Title | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.) Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.) Fulvestrant Anastrozole Everolimus |
| Measure Participants | 12 | 12 |
| Median (95% Confidence Interval) [months] |
11.3
|
9.90
|
| Title | Overall Survival |
|---|---|
| Description | From date of registration to date of death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact. |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment. |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.) Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.) Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.) Fulvestrant Anastrozole Everolimus |
| Measure Participants | 13 | 12 | 12 |
| Median (95% Confidence Interval) [months] |
46.8
|
56.6
|
33.6
|
| Title | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs |
|---|---|
| Description | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Time Frame | Duration of treatment and follow up until death or 5 years post registration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants who received at least one dose of protocol treatment. |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.) Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.) Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.) Fulvestrant Anastrozole Everolimus |
| Measure Participants | 13 | 11 | 12 |
| Abdominal pain |
0
0%
|
1
8.3%
|
0
0%
|
| Anorexia |
0
0%
|
1
8.3%
|
1
8.3%
|
| Aspartate aminotransferase increased |
0
0%
|
1
8.3%
|
0
0%
|
| Dehydration |
0
0%
|
2
16.7%
|
1
8.3%
|
| Diarrhea |
0
0%
|
1
8.3%
|
0
0%
|
| Fatigue |
0
0%
|
2
16.7%
|
0
0%
|
| Flu like symptoms |
0
0%
|
1
8.3%
|
0
0%
|
| Generalized muscle weakness |
0
0%
|
1
8.3%
|
0
0%
|
| Hyperglycemia |
0
0%
|
1
8.3%
|
0
0%
|
| Hypertension |
0
0%
|
2
16.7%
|
2
16.7%
|
| Hypocalcemia |
0
0%
|
1
8.3%
|
0
0%
|
| Hypokalemia |
0
0%
|
2
16.7%
|
1
8.3%
|
| Hyponatremia |
0
0%
|
1
8.3%
|
0
0%
|
| Hypophosphatemia |
0
0%
|
1
8.3%
|
0
0%
|
| Hypotension |
0
0%
|
0
0%
|
1
8.3%
|
| Localized edema |
0
0%
|
1
8.3%
|
0
0%
|
| Lymphocyte count decreased |
0
0%
|
1
8.3%
|
0
0%
|
| Mucositis oral |
0
0%
|
0
0%
|
1
8.3%
|
| Neutrophil count decreased |
0
0%
|
2
16.7%
|
0
0%
|
| Rash maculo-papular |
0
0%
|
0
0%
|
1
8.3%
|
| Resp, thoracic and mediastinal disorders - Other |
0
0%
|
1
8.3%
|
0
0%
|
| Sore throat |
0
0%
|
0
0%
|
1
8.3%
|
| Thromboembolic event |
0
0%
|
0
0%
|
1
8.3%
|
| Vomiting |
0
0%
|
1
8.3%
|
0
0%
|
| White blood cell decreased |
0
0%
|
1
8.3%
|
0
0%
|
| Title | Response Rate |
|---|---|
| Description | Proportion of participants who have confirmed or unconfirmed partial or complete response to therapy |
| Time Frame | assessed every 12 weeks, up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants with measurable disease. |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.) Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.) Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.) Fulvestrant Anastrozole Everolimus |
| Measure Participants | 9 | 10 | 9 |
| Number [percentage of participants] |
22
169.2%
|
60
500%
|
44
366.7%
|
| Title | Clinical Benefit Rate |
|---|---|
| Description | Proportion of participants who have confirmed and unconfirmed partial response, complete response or stable disease. |
| Time Frame | assessed every 12 weeks, up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment. |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.) Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.) Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.) Fulvestrant Anastrozole Everolimus |
| Measure Participants | 13 | 12 | 12 |
| Number [percentage of participants] |
69
530.8%
|
83
691.7%
|
67
558.3%
|
| Title | Molecular Determinants of Response in Circulating Tumor Cells: CTC-ETI |
|---|---|
| Description | CTC-Endocrine Therapy Index (CTC-ETI) on the CellSearch® platform. Based on enumeration of CTC/7.5 mL of whole blood, with >= 5 being elevated. (Due to limited samples collected, full analysis was not able to be performed as planned, so outcome measure reported here is number with elevated Day 1 CTC.) |
| Time Frame | Day 1, Day 29, time of progression (Day 29 to be collected only if Day 1 CTC was elevated.) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with Day 1 whole blood specimen submitted. |
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole |
|---|---|---|---|
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.) Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.) Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.) Fulvestrant Anastrozole Everolimus |
| Measure Participants | 5 | 5 | 3 |
| Count of Participants [Participants] |
1
7.7%
|
1
8.3%
|
0
0%
|
Adverse Events
| Time Frame | Duration of treatment and follow up until death or 5 years post registration | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 36 participants who were eligible and received protocol therapy were assessed for AEs. | |||||
| Arm/Group Title | Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole | |||
| Arm/Group Description | Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Placebo - Anastrozole Placebo - Everolimus | Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Everolimus Placebo - Anastrozole | Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. Fulvestrant Anastrozole Everolimus | |||
All Cause Mortality |
||||||
| Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/13 (61.5%) | 6/12 (50%) | 6/12 (50%) | |||
Serious Adverse Events |
||||||
| Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | 0/11 (0%) | 0/12 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo | Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo | Arm 3: Fulvestrant + Everolimus + Anastrozole | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/13 (100%) | 11/11 (100%) | 12/12 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 4/13 (30.8%) | 8/11 (72.7%) | 6/12 (50%) | |||
| Blood and lymphatic system disorders - Other | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 1/13 (7.7%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Atrioventricular block first degree | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Cardiac disorders-Other | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Chest pain - cardiac | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Left ventricular systolic dysfunction | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Palpitations | 1/13 (7.7%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Pericardial effusion | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Sinus tachycardia | 1/13 (7.7%) | 3/11 (27.3%) | 0/12 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Ear and labyrinth disorders-Other | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Ear pain | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| External ear inflammation | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Tinnitus | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Vertigo | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Eye disorders | ||||||
| Blurred vision | 0/13 (0%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| Conjunctivitis | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Eye disorders-Other | 2/13 (15.4%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Floaters | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Watering eyes | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 3/13 (23.1%) | 4/11 (36.4%) | 1/12 (8.3%) | |||
| Anal hemorrhage | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Ascites | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Bloating | 0/13 (0%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| Colitis | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Constipation | 4/13 (30.8%) | 6/11 (54.5%) | 7/12 (58.3%) | |||
| Dental caries | 1/13 (7.7%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Diarrhea | 2/13 (15.4%) | 5/11 (45.5%) | 4/12 (33.3%) | |||
| Dry mouth | 3/13 (23.1%) | 3/11 (27.3%) | 0/12 (0%) | |||
| Dyspepsia | 0/13 (0%) | 4/11 (36.4%) | 3/12 (25%) | |||
| Dysphagia | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Esophagitis | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Fecal incontinence | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Flatulence | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Gastroesophageal reflux disease | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Gastrointestinal disorders-Other | 1/13 (7.7%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Gastrointestinal pain | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Ileus | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Mucositis oral | 3/13 (23.1%) | 7/11 (63.6%) | 8/12 (66.7%) | |||
| Nausea | 5/13 (38.5%) | 6/11 (54.5%) | 4/12 (33.3%) | |||
| Oral pain | 2/13 (15.4%) | 2/11 (18.2%) | 3/12 (25%) | |||
| Rectal hemorrhage | 1/13 (7.7%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Stomach pain | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Vomiting | 1/13 (7.7%) | 3/11 (27.3%) | 4/12 (33.3%) | |||
| General disorders | ||||||
| Chills | 1/13 (7.7%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Edema face | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Edema limbs | 4/13 (30.8%) | 6/11 (54.5%) | 3/12 (25%) | |||
| Fatigue | 10/13 (76.9%) | 10/11 (90.9%) | 7/12 (58.3%) | |||
| Fever | 3/13 (23.1%) | 3/11 (27.3%) | 1/12 (8.3%) | |||
| Flu like symptoms | 0/13 (0%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| General disorders and admin site conditions - Other | 1/13 (7.7%) | 3/11 (27.3%) | 0/12 (0%) | |||
| Injection site reaction | 2/13 (15.4%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Localized edema | 0/13 (0%) | 3/11 (27.3%) | 1/12 (8.3%) | |||
| Malaise | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Non-cardiac chest pain | 0/13 (0%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Pain | 4/13 (30.8%) | 2/11 (18.2%) | 3/12 (25%) | |||
| Immune system disorders | ||||||
| Allergic reaction | 1/13 (7.7%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Immune system disorders-Other | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Infections and infestations | ||||||
| Infections and infestations-Other | 1/13 (7.7%) | 4/11 (36.4%) | 2/12 (16.7%) | |||
| Mucosal infection | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Rhinitis infective | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Sinusitis | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Skin infection | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Tooth infection | 1/13 (7.7%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Upper respiratory infection | 2/13 (15.4%) | 1/11 (9.1%) | 3/12 (25%) | |||
| Urinary tract infection | 0/13 (0%) | 0/11 (0%) | 2/12 (16.7%) | |||
| Vaginal infection | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Burn | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Dermatitis radiation | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Fracture | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 2/13 (15.4%) | 6/11 (54.5%) | 3/12 (25%) | |||
| Alkaline phosphatase increased | 3/13 (23.1%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Aspartate aminotransferase increased | 4/13 (30.8%) | 7/11 (63.6%) | 4/12 (33.3%) | |||
| Blood bilirubin increased | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Cholesterol high | 4/13 (30.8%) | 10/11 (90.9%) | 5/12 (41.7%) | |||
| Creatinine increased | 0/13 (0%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Electrocardiogram QT corrected interval prolonged | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| INR increased | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Investigations-Other | 0/13 (0%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Lipase increased | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Lymphocyte count decreased | 1/13 (7.7%) | 7/11 (63.6%) | 4/12 (33.3%) | |||
| Neutrophil count decreased | 0/13 (0%) | 3/11 (27.3%) | 1/12 (8.3%) | |||
| Platelet count decreased | 1/13 (7.7%) | 4/11 (36.4%) | 4/12 (33.3%) | |||
| Weight gain | 1/13 (7.7%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Weight loss | 2/13 (15.4%) | 6/11 (54.5%) | 3/12 (25%) | |||
| White blood cell decreased | 0/13 (0%) | 7/11 (63.6%) | 4/12 (33.3%) | |||
| Metabolism and nutrition disorders | ||||||
| Anorexia | 3/13 (23.1%) | 7/11 (63.6%) | 3/12 (25%) | |||
| Dehydration | 0/13 (0%) | 3/11 (27.3%) | 1/12 (8.3%) | |||
| Glucose intolerance | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Hypercalcemia | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Hyperglycemia | 8/13 (61.5%) | 7/11 (63.6%) | 5/12 (41.7%) | |||
| Hypernatremia | 0/13 (0%) | 2/11 (18.2%) | 3/12 (25%) | |||
| Hypertriglyceridemia | 4/13 (30.8%) | 8/11 (72.7%) | 6/12 (50%) | |||
| Hypoalbuminemia | 1/13 (7.7%) | 7/11 (63.6%) | 1/12 (8.3%) | |||
| Hypocalcemia | 2/13 (15.4%) | 2/11 (18.2%) | 2/12 (16.7%) | |||
| Hypokalemia | 2/13 (15.4%) | 5/11 (45.5%) | 3/12 (25%) | |||
| Hypomagnesemia | 0/13 (0%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| Hyponatremia | 2/13 (15.4%) | 4/11 (36.4%) | 2/12 (16.7%) | |||
| Hypophosphatemia | 1/13 (7.7%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| Metabolism and nutrition disorders - Other, specify | 0/13 (0%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/13 (7.7%) | 3/11 (27.3%) | 4/12 (33.3%) | |||
| Arthritis | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Avascular necrosis | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Back pain | 3/13 (23.1%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Bone pain | 5/13 (38.5%) | 2/11 (18.2%) | 3/12 (25%) | |||
| Chest wall pain | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Generalized muscle weakness | 1/13 (7.7%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Joint range of motion decreased | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Musculoskeletal and connective tiss disorder - Other | 1/13 (7.7%) | 3/11 (27.3%) | 0/12 (0%) | |||
| Myalgia | 4/13 (30.8%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Neck pain | 1/13 (7.7%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Osteonecrosis of jaw | 1/13 (7.7%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Pain in extremity | 5/13 (38.5%) | 5/11 (45.5%) | 1/12 (8.3%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Tumor pain | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Nervous system disorders | ||||||
| Dizziness | 0/13 (0%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Dysesthesia | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Dysgeusia | 1/13 (7.7%) | 6/11 (54.5%) | 0/12 (0%) | |||
| Headache | 4/13 (30.8%) | 4/11 (36.4%) | 5/12 (41.7%) | |||
| Memory impairment | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Nervous system disorders-Other | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Paresthesia | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Peripheral motor neuropathy | 0/13 (0%) | 2/11 (18.2%) | 2/12 (16.7%) | |||
| Peripheral sensory neuropathy | 3/13 (23.1%) | 5/11 (45.5%) | 1/12 (8.3%) | |||
| Syncope | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Psychiatric disorders | ||||||
| Agitation | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Anxiety | 1/13 (7.7%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Depression | 2/13 (15.4%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Insomnia | 3/13 (23.1%) | 3/11 (27.3%) | 2/12 (16.7%) | |||
| Restlessness | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/13 (0%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| Chronic kidney disease | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Cystitis noninfective | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Hematuria | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Renal and urinary disorders-Other | 1/13 (7.7%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Urinary frequency | 1/13 (7.7%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Urinary incontinence | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Urinary tract pain | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Urinary urgency | 0/13 (0%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Reproductive system and breast disorders | ||||||
| Reproductive system and breast disorders - Other | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Vaginal discharge | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Vaginal pain | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Allergic rhinitis | 2/13 (15.4%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Atelectasis | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Cough | 5/13 (38.5%) | 7/11 (63.6%) | 4/12 (33.3%) | |||
| Dyspnea | 6/13 (46.2%) | 3/11 (27.3%) | 3/12 (25%) | |||
| Epistaxis | 0/13 (0%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Hoarseness | 2/13 (15.4%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Nasal congestion | 0/13 (0%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Pleural effusion | 2/13 (15.4%) | 0/11 (0%) | 0/12 (0%) | |||
| Pneumonitis | 0/13 (0%) | 3/11 (27.3%) | 1/12 (8.3%) | |||
| Postnasal drip | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Productive cough | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Resp, thoracic and mediastinal disorders - Other | 0/13 (0%) | 3/11 (27.3%) | 1/12 (8.3%) | |||
| Sleep apnea | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Sore throat | 3/13 (23.1%) | 3/11 (27.3%) | 2/12 (16.7%) | |||
| Voice alteration | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Wheezing | 1/13 (7.7%) | 1/11 (9.1%) | 2/12 (16.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 1/13 (7.7%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| Dry skin | 1/13 (7.7%) | 3/11 (27.3%) | 1/12 (8.3%) | |||
| Erythema multiforme | 0/13 (0%) | 1/11 (9.1%) | 1/12 (8.3%) | |||
| Nail discoloration | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Pruritus | 0/13 (0%) | 2/11 (18.2%) | 1/12 (8.3%) | |||
| Rash acneiform | 1/13 (7.7%) | 4/11 (36.4%) | 1/12 (8.3%) | |||
| Rash maculo-papular | 0/13 (0%) | 4/11 (36.4%) | 3/12 (25%) | |||
| Skin and subcutaneous tissue disorders - Other | 2/13 (15.4%) | 2/11 (18.2%) | 0/12 (0%) | |||
| Skin hyperpigmentation | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Skin induration | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Skin ulceration | 1/13 (7.7%) | 0/11 (0%) | 0/12 (0%) | |||
| Vascular disorders | ||||||
| Flushing | 0/13 (0%) | 1/11 (9.1%) | 0/12 (0%) | |||
| Hot flashes | 6/13 (46.2%) | 6/11 (54.5%) | 5/12 (41.7%) | |||
| Hypertension | 2/13 (15.4%) | 5/11 (45.5%) | 4/12 (33.3%) | |||
| Hypotension | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Thromboembolic event | 0/13 (0%) | 0/11 (0%) | 1/12 (8.3%) | |||
| Vascular disorders-Other | 0/13 (0%) | 2/11 (18.2%) | 0/12 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Breast Committee Statistician |
|---|---|
| Organization | SWOG Statistics and Data Management Center |
| Phone | 2066674623 |
| dlew@fredhutch.org |
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT02137837
Other Study ID Numbers:
- S1222
First Posted:
May 14, 2014
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021