Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03633331
Collaborator
National Cancer Institute (NCI) (NIH)
93
447
1
71.6
0.2
0
Study Details
Study Description
Brief Summary
This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- To estimate the safety and tolerability (adverse event rate) of the combination of palbociclib and letrozole or fulvestrant in adults age 70 or older with estrogen receptor-positive, HER2-negative metastatic breast cancer.
SECONDARY OBJECTIVES:
-
To describe the full toxicity profile including all grade 2 and higher adverse events (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0), specifically estimating the rate of grade 2 and higher myelosuppression (neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal (GI) side effects (nausea, diarrhea, decreased appetite, vomiting, mucositis-oral), fatigue, neuropathy, and thromboembolism.
-
To describe rates of dose reductions, dose holds, and hospitalizations. III. To estimate median time to treatment failure, including progression free survival and overall survival.
-
To estimate the rate of adherence to palbociclib, letrozole and fulvestrant.
-
To explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.
-
To describe the results of the Overall Treatment Utility (OTU). VII. To determine the degree of agreement between patient-reported adverse events (AEs) using Patient Reported Outcomes (PRO)-CTCAE measures and those reported using traditional collections for AEs.
-
To examine the association between sarcopenia and the development of toxicity and adverse events.
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of subsequent courses per Doctor of Medicine (MD) discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
93 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Actual Study Start Date
:
Aug 15, 2018
Actual Primary Completion Date
:
Sep 8, 2020
Anticipated Study Completion Date
:
Aug 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (palbociclib, letrozole or fulvestrant) Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Drug: Palbociclib
Given PO
Drug: Letrozole
Given PO
Drug: Fulvestrant
Given IM
Other: Questionnaire Administration
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events [6 months]
Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval.
Secondary Outcome Measures
- Incidence of Drug Toxicities - Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0 [Up to 1 year]
Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0
- Dose Reduction, Dose Hold, and Hospitalization Reasons [Up to 1 year]
A 95% binomial confidence interval for single proportions will be constructed for the percentage of patients that had at least one dose reduction, dose hold, or hospitalization within the first year of treatment.
- Time to Treatment Failure (and Reason for Coming Off Study - Toxicity, Patient Preference, Progression) [Up to 5 years]
Distributions time to treatment failure will be estimated using Kaplan-Meier methodology. Treatment failure is defined as a severe adverse event, disease progression or patient refusal to continue assigned treatment. Any reason that treatment is discontinued to time to treatment failure and not censor patients will be included. The reason for treatment discontinuation will be captured.
- Palbociclib Adherence Rate [Up to 12 weeks]
Patients to be included in the analysis cohort will be those patients who have taken one or more doses of the study treatment. Those patients will be considered adherent to study treatment. For each of the first 3 cycles, an estimate of the proportion of patients who meet the criteria for adherence and its corresponding 95% confidence interval will be determined.
- Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) [Up to 1 year]
The response rate is defined as the proportion of patients whose disease status met Response Evaluation Criteria in Solid Tumors (RECIST) criteria for complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 8 weeks apart. A 95% binomial confidence interval for the response rate will be constructed.
- Progression Free Survival (PFS) [From start of treatment to the first of the following disease events: local/regional/distant recurrence, invasive contralateral breast disease, second primary or death due to any cause, assessed up to 5 years]
Distributions of progression free survival (PFS) times will be estimated using Kaplan-Meier methodology.
- Overall Survival (OS) [Up to 5 years]
Distributions of overall survival (OS) times will be estimated using Kaplan-Meier methodology.
- Overall Treatment Utility (OTU) Results [Up to 1 year]
OTU is a novel composite endpoint developed by investigators of the FOCUS2 trial to assess the outcome of palliative chemotherapy. The patient will be given either an overall score of "good", "intermediate", or "poor". A 95% binomial confidence interval will be constructed for the percentage of patients that scored "good" on the OTU.
- Sarcopenia Analysis [Up to 1 year]
Will examine variables associated with skeletal muscle loss during treatment and whether skeletal muscle loss during treatment is associated with the presence of grade 3-5 toxicity and adverse events. Sarcopenia will be treated as a binary variable using the Skeletal Muscle Index (SMI) (SMI < 41 cm^2/m^2 vs. SMI > 41 cm^2/m^2) and differences in grades chemotherapy toxicity and adverse events will be analyzed using two group t-tests and fisher's exact test. The number of patients with and without sarcopenia grouped by patients with or without grade 3+ Adverse Events (AE's) will be also be reported.
- Quality of Life as Measured by the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) [Up to 1 year]
European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) is comprised of 5 dimensions. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, no problems, some problems, extreme problems. The EQ-5D-3L can be converted to a single summary index. The median and range of this total score will be reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
70 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
-
Measurable disease or non-measurable disease
-
Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration
-
No prior therapy with a CDK inhibitor
-
Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration
-
No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible
-
No known interstitial lung disease
-
No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years
-
No active infection requiring treatment with antibiotics
-
Patients must be able to swallow and retain oral medication
-
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
-
Patients must be able to read and comprehend English or Spanish
-
Absolute neutrophil count (ANC) >= 1500/mm3 (1.5 x 109/L)
-
Platelet count >= 100,000/mm3 (100 x 109/L)
-
Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula
-
Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
-
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
-
Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anchorage Associates in Radiation Medicine | Anchorage | Alaska | United States | 98508 |
| 2 | Anchorage Radiation Therapy Center | Anchorage | Alaska | United States | 99504 |
| 3 | Alaska Breast Care and Surgery LLC | Anchorage | Alaska | United States | 99508 |
| 4 | Alaska Oncology and Hematology LLC | Anchorage | Alaska | United States | 99508 |
| 5 | Alaska Women's Cancer Care | Anchorage | Alaska | United States | 99508 |
| 6 | Anchorage Oncology Centre | Anchorage | Alaska | United States | 99508 |
| 7 | Katmai Oncology Group | Anchorage | Alaska | United States | 99508 |
| 8 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 9 | Kingman Regional Medical Center | Kingman | Arizona | United States | 86401 |
| 10 | PCR Oncology | Arroyo Grande | California | United States | 93420 |
| 11 | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | United States | 91505 |
| 12 | City of Hope Corona | Corona | California | United States | 92879 |
| 13 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 14 | City of Hope Antelope Valley | Lancaster | California | United States | 93534 |
| 15 | City of Hope Mission Hills | Mission Hills | California | United States | 91345 |
| 16 | Saint Joseph Hospital - Orange | Orange | California | United States | 92868 |
| 17 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 18 | City of Hope - Santa Clarita | Santa Clarita | California | United States | 91355 |
| 19 | City of Hope South Pasadena | South Pasadena | California | United States | 91030 |
| 20 | City of Hope Upland | Upland | California | United States | 91786 |
| 21 | City of Hope West Covina | West Covina | California | United States | 91790 |
| 22 | Cancer Center of Colorado at Sloan's Lake | Denver | Colorado | United States | 80204 |
| 23 | SCL Health Saint Joseph Hospital | Denver | Colorado | United States | 80218 |
| 24 | Good Samaritan Medical Center | Lafayette | Colorado | United States | 80026 |
| 25 | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
| 26 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 27 | Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | United States | 19713 |
| 28 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 29 | Medical Oncology Hematology Consultants PA | Newark | Delaware | United States | 19713 |
| 30 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
| 31 | Beebe Health Campus | Rehoboth Beach | Delaware | United States | 19971 |
| 32 | Nanticoke Memorial Hospital | Seaford | Delaware | United States | 19973 |
| 33 | Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | United States | 19801 |
| 34 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
| 35 | The Watson Clinic | Lakeland | Florida | United States | 33805 |
| 36 | Hawaii Cancer Care - Savio | 'Aiea | Hawaii | United States | 96701 |
| 37 | Hawaii Oncology Inc-Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 38 | Pali Momi Medical Center | 'Aiea | Hawaii | United States | 96701 |
| 39 | The Cancer Center of Hawaii-Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 40 | Hawaii Cancer Care Inc-POB II | Honolulu | Hawaii | United States | 96813 |
| 41 | Hawaii Oncology Inc-POB I | Honolulu | Hawaii | United States | 96813 |
| 42 | Island Urology | Honolulu | Hawaii | United States | 96813 |
| 43 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 44 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813 |
| 45 | University of Hawaii Cancer Center | Honolulu | Hawaii | United States | 96813 |
| 46 | Hawaii Cancer Care Inc-Liliha | Honolulu | Hawaii | United States | 96817 |
| 47 | Hawaii Oncology Inc-Kuakini | Honolulu | Hawaii | United States | 96817 |
| 48 | Kuakini Medical Center | Honolulu | Hawaii | United States | 96817 |
| 49 | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | United States | 96817 |
| 50 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 51 | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii | United States | 96766 |
| 52 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | United States | 83706 |
| 53 | Saint Luke's Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
| 54 | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | United States | 83605 |
| 55 | Kootenai Medical Center | Coeur d'Alene | Idaho | United States | 83814 |
| 56 | Walter Knox Memorial Hospital | Emmett | Idaho | United States | 83617 |
| 57 | Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho | United States | 83619 |
| 58 | Idaho Urologic Institute-Meridian | Meridian | Idaho | United States | 83642 |
| 59 | Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho | United States | 83642 |
| 60 | Saint Alphonsus Medical Center-Nampa | Nampa | Idaho | United States | 83686 |
| 61 | Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho | United States | 83686 |
| 62 | Kootenai Cancer Center | Post Falls | Idaho | United States | 83854 |
| 63 | Kootenai Cancer Clinic | Sandpoint | Idaho | United States | 83864 |
| 64 | Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho | United States | 83301 |
| 65 | Rush - Copley Medical Center | Aurora | Illinois | United States | 60504 |
| 66 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
| 67 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 68 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 69 | Centralia Oncology Clinic | Centralia | Illinois | United States | 62801 |
| 70 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 71 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 72 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 73 | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | United States | 62526 |
| 74 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 75 | Illinois CancerCare-Dixon | Dixon | Illinois | United States | 61021 |
| 76 | Carle Physician Group-Effingham | Effingham | Illinois | United States | 62401 |
| 77 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 78 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
| 79 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
| 80 | Western Illinois Cancer Treatment Center | Galesburg | Illinois | United States | 61401 |
| 81 | Joliet Oncology-Hematology Associates Limited | Joliet | Illinois | United States | 60435 |
| 82 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 83 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 84 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 85 | Good Samaritan Regional Health Center | Mount Vernon | Illinois | United States | 62864 |
| 86 | UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | United States | 60451 |
| 87 | University of Chicago Medicine-Orland Park | Orland Park | Illinois | United States | 60462 |
| 88 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 89 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
| 90 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 91 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 92 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
| 93 | Valley Radiation Oncology | Peru | Illinois | United States | 61354 |
| 94 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
| 95 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 96 | Springfield Clinic | Springfield | Illinois | United States | 62702 |
| 97 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 98 | Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois | United States | 62226 |
| 99 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 100 | The Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 101 | Rush-Copley Healthcare Center | Yorkville | Illinois | United States | 60560 |
| 102 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 103 | Mary Greeley Medical Center | Ames | Iowa | United States | 50010 |
| 104 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 105 | McFarland Clinic PC-Boone | Boone | Iowa | United States | 50036 |
| 106 | Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa | United States | 52402 |
| 107 | Mercy Hospital | Cedar Rapids | Iowa | United States | 52403 |
| 108 | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | United States | 52403 |
| 109 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 110 | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | United States | 50309 |
| 111 | Broadlawns Medical Center | Des Moines | Iowa | United States | 50314 |
| 112 | Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
| 113 | McFarland Clinic PC-Trinity Cancer Center | Fort Dodge | Iowa | United States | 50501 |
| 114 | Trinity Regional Medical Center | Fort Dodge | Iowa | United States | 50501 |
| 115 | McFarland Clinic PC-Jefferson | Jefferson | Iowa | United States | 50129 |
| 116 | McFarland Clinic PC-Marshalltown | Marshalltown | Iowa | United States | 50158 |
| 117 | Siouxland Regional Cancer Center | Sioux City | Iowa | United States | 51101 |
| 118 | Methodist West Hospital | West Des Moines | Iowa | United States | 50266-7700 |
| 119 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
| 120 | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 121 | Cancer Center of Kansas - Wichita | Wichita | Kansas | United States | 67214 |
| 122 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 123 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 124 | Lafayette Family Cancer Center-EMMC | Brewer | Maine | United States | 04412 |
| 125 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 126 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
| 127 | UM Saint Joseph Medical Center | Towson | Maryland | United States | 21204 |
| 128 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 129 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 130 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 131 | Steward Saint Elizabeth's Medical Center | Brighton | Massachusetts | United States | 02135 |
| 132 | Dana-Farber/Brigham and Women's Cancer Center at Milford Regional | Milford | Massachusetts | United States | 01757 |
| 133 | Dana-Farber/Brigham and Women's Cancer Center at South Shore | South Weymouth | Massachusetts | United States | 02190 |
| 134 | Hickman Cancer Center | Adrian | Michigan | United States | 49221 |
| 135 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 136 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
| 137 | McLaren Cancer Institute-Bay City | Bay City | Michigan | United States | 48706 |
| 138 | IHA Hematology Oncology Consultants-Brighton | Brighton | Michigan | United States | 48114 |
| 139 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 140 | IHA Hematology Oncology Consultants-Canton | Canton | Michigan | United States | 48188 |
| 141 | Saint Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 142 | Caro Cancer Center | Caro | Michigan | United States | 48723 |
| 143 | IHA Hematology Oncology Consultants-Chelsea | Chelsea | Michigan | United States | 48118 |
| 144 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 145 | Hematology Oncology Consultants-Clarkston | Clarkston | Michigan | United States | 48346 |
| 146 | McLaren Cancer Institute-Clarkston | Clarkston | Michigan | United States | 48346 |
| 147 | Newland Medical Associates-Clarkston | Clarkston | Michigan | United States | 48346 |
| 148 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 149 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 150 | Great Lakes Cancer Management Specialists-Doctors Park | East China Township | Michigan | United States | 48054 |
| 151 | Weisberg Cancer Treatment Center | Farmington Hills | Michigan | United States | 48334 |
| 152 | Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | United States | 48503 |
| 153 | Genesee Hematology Oncology PC | Flint | Michigan | United States | 48503 |
| 154 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 155 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 156 | McLaren Cancer Institute-Flint | Flint | Michigan | United States | 48532 |
| 157 | Singh and Arora Hematology Oncology PC | Flint | Michigan | United States | 48532 |
| 158 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 159 | Academic Hematology Oncology Specialists | Grosse Pointe Woods | Michigan | United States | 48236 |
| 160 | Great Lakes Cancer Management Specialists-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan | United States | 48236 |
| 161 | Michigan Breast Specialists-Grosse Pointe Woods | Grosse Pointe Woods | Michigan | United States | 48236 |
| 162 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 163 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 164 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49048 |
| 165 | McLaren-Greater Lansing | Lansing | Michigan | United States | 48910 |
| 166 | Mid-Michigan Physicians-Lansing | Lansing | Michigan | United States | 48912 |
| 167 | Sparrow Hospital | Lansing | Michigan | United States | 48912 |
| 168 | McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | United States | 48446 |
| 169 | Hope Cancer Clinic | Livonia | Michigan | United States | 48154 |
| 170 | Saint Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
| 171 | Great Lakes Cancer Management Specialists-Macomb Medical Campus | Macomb | Michigan | United States | 48044 |
| 172 | Michigan Breast Specialists-Macomb Township | Macomb | Michigan | United States | 48044 |
| 173 | Saint Mary's Oncology/Hematology Associates of Marlette | Marlette | Michigan | United States | 48453 |
| 174 | Toledo Clinic Cancer Centers-Monroe | Monroe | Michigan | United States | 48162 |
| 175 | McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | United States | 48043 |
| 176 | McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan | United States | 48858 |
| 177 | McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | United States | 49770 |
| 178 | 21st Century Oncology-Pontiac | Pontiac | Michigan | United States | 48341 |
| 179 | Hope Cancer Center | Pontiac | Michigan | United States | 48341 |
| 180 | Newland Medical Associates-Pontiac | Pontiac | Michigan | United States | 48341 |
| 181 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
| 182 | McLaren-Port Huron | Port Huron | Michigan | United States | 48060 |
| 183 | Spectrum Health Reed City Hospital | Reed City | Michigan | United States | 49677 |
| 184 | Great Lakes Cancer Management Specialists-Rochester Hills | Rochester Hills | Michigan | United States | 48309 |
| 185 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
| 186 | Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan | United States | 48604 |
| 187 | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | United States | 49085 |
| 188 | Marie Yeager Cancer Center | Saint Joseph | Michigan | United States | 49085 |
| 189 | Bhadresh Nayak MD PC-Sterling Heights | Sterling Heights | Michigan | United States | 48312 |
| 190 | Ascension Saint Joseph Hospital | Tawas City | Michigan | United States | 48764 |
| 191 | Advanced Breast Care Center PLLC | Warren | Michigan | United States | 48088 |
| 192 | Great Lakes Cancer Management Specialists-Macomb Professional Building | Warren | Michigan | United States | 48093 |
| 193 | Macomb Hematology Oncology PC | Warren | Michigan | United States | 48093 |
| 194 | Michigan Breast Specialists-Warren | Warren | Michigan | United States | 48093 |
| 195 | Saint John Macomb-Oakland Hospital | Warren | Michigan | United States | 48093 |
| 196 | Saint Mary's Oncology/Hematology Associates of West Branch | West Branch | Michigan | United States | 48661 |
| 197 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 198 | Huron Gastroenterology PC | Ypsilanti | Michigan | United States | 48106 |
| 199 | IHA Hematology Oncology Consultants-Ann Arbor | Ypsilanti | Michigan | United States | 48197 |
| 200 | Riverwood Healthcare Center | Aitkin | Minnesota | United States | 56431 |
| 201 | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | United States | 56601 |
| 202 | Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | United States | 56401 |
| 203 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 204 | Cambridge Medical Center | Cambridge | Minnesota | United States | 55008 |
| 205 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 206 | Essentia Health - Deer River Clinic | Deer River | Minnesota | United States | 56636 |
| 207 | Essentia Health Saint Mary's - Detroit Lakes Clinic | Detroit Lakes | Minnesota | United States | 56501 |
| 208 | Essentia Health Cancer Center | Duluth | Minnesota | United States | 55805 |
| 209 | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | United States | 55805 |
| 210 | Miller-Dwan Hospital | Duluth | Minnesota | United States | 55805 |
| 211 | Fairview-Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 212 | Lake Region Healthcare Corporation-Cancer Care | Fergus Falls | Minnesota | United States | 56537 |
| 213 | Essentia Health - Fosston | Fosston | Minnesota | United States | 56542 |
| 214 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 215 | Essentia Health Hibbing Clinic | Hibbing | Minnesota | United States | 55746 |
| 216 | Fairview Maple Grove Medical Center | Maple Grove | Minnesota | United States | 55369 |
| 217 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
| 218 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
| 219 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 220 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 221 | Health Partners Inc | Minneapolis | Minnesota | United States | 55454 |
| 222 | Monticello Cancer Center | Monticello | Minnesota | United States | 55362 |
| 223 | New Ulm Medical Center | New Ulm | Minnesota | United States | 56073 |
| 224 | Essentia Health - Park Rapids | Park Rapids | Minnesota | United States | 56470 |
| 225 | Fairview Northland Medical Center | Princeton | Minnesota | United States | 55371 |
| 226 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
| 227 | Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | United States | 56303 |
| 228 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 229 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 230 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 231 | Essentia Health Sandstone | Sandstone | Minnesota | United States | 55072 |
| 232 | Saint Francis Regional Medical Center | Shakopee | Minnesota | United States | 55379 |
| 233 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
| 234 | Sanford Thief River Falls Medical Center | Thief River Falls | Minnesota | United States | 56701 |
| 235 | Essentia Health Virginia Clinic | Virginia | Minnesota | United States | 55792 |
| 236 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 237 | Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
| 238 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
| 239 | Sanford Cancer Center Worthington | Worthington | Minnesota | United States | 56187 |
| 240 | Fairview Lakes Medical Center | Wyoming | Minnesota | United States | 55092 |
| 241 | Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri | United States | 63011 |
| 242 | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | United States | 63628 |
| 243 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 244 | Southeast Cancer Center | Cape Girardeau | Missouri | United States | 63703 |
| 245 | Saint Luke's Hospital | Chesterfield | Missouri | United States | 63017 |
| 246 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
| 247 | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | United States | 63141 |
| 248 | Parkland Health Center - Farmington | Farmington | Missouri | United States | 63640 |
| 249 | Capital Region Southwest Campus | Jefferson City | Missouri | United States | 65109 |
| 250 | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri | United States | 63109 |
| 251 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 252 | Mercy Hospital South | Saint Louis | Missouri | United States | 63128 |
| 253 | Siteman Cancer Center-South County | Saint Louis | Missouri | United States | 63129 |
| 254 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 255 | Siteman Cancer Center at Christian Hospital | Saint Louis | Missouri | United States | 63136 |
| 256 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 257 | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri | United States | 63376 |
| 258 | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | United States | 63670 |
| 259 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
| 260 | Missouri Baptist Sullivan Hospital | Sullivan | Missouri | United States | 63080 |
| 261 | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | United States | 63127 |
| 262 | Mercy Hospital Washington | Washington | Missouri | United States | 63090 |
| 263 | Community Hospital of Anaconda | Anaconda | Montana | United States | 59711 |
| 264 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 265 | Bozeman Deaconess Hospital | Bozeman | Montana | United States | 59715 |
| 266 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 267 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
| 268 | Saint Patrick Hospital - Community Hospital | Missoula | Montana | United States | 59802 |
| 269 | Community Medical Hospital | Missoula | Montana | United States | 59804 |
| 270 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
| 271 | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | United States | 89052 |
| 272 | Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada | United States | 89052 |
| 273 | Las Vegas Cancer Center-Henderson | Henderson | Nevada | United States | 89052 |
| 274 | OptumCare Cancer Care at Seven Hills | Henderson | Nevada | United States | 89052 |
| 275 | Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada | United States | 89074 |
| 276 | Desert West Surgery | Las Vegas | Nevada | United States | 89102 |
| 277 | OptumCare Cancer Care at Oakey | Las Vegas | Nevada | United States | 89102 |
| 278 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 279 | Hope Cancer Care of Nevada | Las Vegas | Nevada | United States | 89103 |
| 280 | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | United States | 89106 |
| 281 | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | United States | 89119 |
| 282 | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | United States | 89128 |
| 283 | OptumCare Cancer Care at MountainView | Las Vegas | Nevada | United States | 89128 |
| 284 | Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas | Nevada | United States | 89144 |
| 285 | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | United States | 89144 |
| 286 | Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada | United States | 89148-2405 |
| 287 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89148 |
| 288 | OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | United States | 89148 |
| 289 | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | United States | 89169 |
| 290 | Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada | United States | 89048 |
| 291 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
| 292 | Radiation Oncology Associates | Reno | Nevada | United States | 89509 |
| 293 | New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | United States | 03301 |
| 294 | New Hampshire Oncology Hematology PA-Hooksett | Hooksett | New Hampshire | United States | 03106 |
| 295 | The Dana-Farber Cancer Institute at Londonderry | Londonderry | New Hampshire | United States | 03053 |
| 296 | AtlantiCare Health Park-Cape May Court House | Cape May Court House | New Jersey | United States | 08210 |
| 297 | AtlantiCare Surgery Center | Egg Harbor Township | New Jersey | United States | 08234 |
| 298 | Lovelace Medical Center-Saint Joseph Square | Albuquerque | New Mexico | United States | 87102 |
| 299 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 300 | Presbyterian Kaseman Hospital | Albuquerque | New Mexico | United States | 87110 |
| 301 | Presbyterian Rust Medical Center/Jorgensen Cancer Center | Rio Rancho | New Mexico | United States | 87124 |
| 302 | Christus Saint Vincent Regional Cancer Center | Santa Fe | New Mexico | United States | 87505 |
| 303 | Hematology Oncology Associates of Central New York-Auburn | Auburn | New York | United States | 13021 |
| 304 | Northwell Health Imbert Cancer Center | Bay Shore | New York | United States | 11706 |
| 305 | Montefiore Medical Center-Einstein Campus | Bronx | New York | United States | 10461 |
| 306 | Montefiore Medical Center-Weiler Hospital | Bronx | New York | United States | 10461 |
| 307 | Montefiore Medical Center - Moses Campus | Bronx | New York | United States | 10467 |
| 308 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 309 | Hematology Oncology Associates of Central New York-East Syracuse | East Syracuse | New York | United States | 13057 |
| 310 | Glens Falls Hospital | Glens Falls | New York | United States | 12801 |
| 311 | Northwell Health Cancer Institute at Huntington | Greenlawn | New York | United States | 11740 |
| 312 | Northwell Health/Center for Advanced Medicine | Lake Success | New York | United States | 11042 |
| 313 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 314 | Hematology Oncology Associates of Central New York-Onondaga Hill | Syracuse | New York | United States | 13215 |
| 315 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 316 | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | United States | 28328 |
| 317 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 318 | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | United States | 27534 |
| 319 | Wayne Memorial Hospital | Goldsboro | North Carolina | United States | 27534 |
| 320 | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | United States | 28546 |
| 321 | Novant Health Oncology Specialists-Kernersville | Kernersville | North Carolina | United States | 27284 |
| 322 | Novant Health Oncology Specialists-Mount Airy | Mount Airy | North Carolina | United States | 27030 |
| 323 | CarolinaEast Medical Center | New Bern | North Carolina | United States | 28561 |
| 324 | CarolinaEast Oncology and Hematology Associates | New Bern | North Carolina | United States | 28562 |
| 325 | Novant Health Oncology Specialists-Statesville | Statesville | North Carolina | United States | 28625 |
| 326 | Novant Health Oncology Specialists-Davidson County | Thomasville | North Carolina | United States | 27360 |
| 327 | Novant Health Oncology Specialists-Wilkesboro | Wilkesboro | North Carolina | United States | 28659 |
| 328 | Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | United States | 27103 |
| 329 | Novant Health Oncology Specialists | Winston-Salem | North Carolina | United States | 27103 |
| 330 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 331 | Sanford Bismarck Medical Center | Bismarck | North Dakota | United States | 58501 |
| 332 | Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota | United States | 58103 |
| 333 | Sanford South University Medical Center | Fargo | North Dakota | United States | 58103 |
| 334 | Sanford Medical Center Fargo | Fargo | North Dakota | United States | 58104 |
| 335 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 336 | Sanford Roger Maris Cancer Center | Fargo | North Dakota | United States | 58122 |
| 337 | Altru Cancer Center | Grand Forks | North Dakota | United States | 58201 |
| 338 | Essentia Health - Jamestown Clinic | Jamestown | North Dakota | United States | 58401 |
| 339 | Strecker Cancer Center-Belpre | Belpre | Ohio | United States | 45714 |
| 340 | Mercy Medical Center | Canton | Ohio | United States | 44708 |
| 341 | Mount Carmel East Hospital | Columbus | Ohio | United States | 43213 |
| 342 | Grant Medical Center | Columbus | Ohio | United States | 43215 |
| 343 | The Mark H Zangmeister Center | Columbus | Ohio | United States | 43219 |
| 344 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
| 345 | Delaware Health Center-Grady Cancer Center | Delaware | Ohio | United States | 43015 |
| 346 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
| 347 | Mount Carmel Grove City Hospital | Grove City | Ohio | United States | 43123 |
| 348 | Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
| 349 | Mercy Health Perrysburg Cancer Center | Perrysburg | Ohio | United States | 43551 |
| 350 | Mercy Saint Anne Hospital | Toledo | Ohio | United States | 43623 |
| 351 | Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | United States | 43623 |
| 352 | Saint Ann's Hospital | Westerville | Ohio | United States | 43081 |
| 353 | Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | United States | 73120 |
| 354 | Saint Alphonsus Medical Center-Baker City | Baker City | Oregon | United States | 97814 |
| 355 | Saint Charles Health System | Bend | Oregon | United States | 97701 |
| 356 | Clackamas Radiation Oncology Center | Clackamas | Oregon | United States | 97015 |
| 357 | Providence Cancer Institute Clackamas Clinic | Clackamas | Oregon | United States | 97015 |
| 358 | Bay Area Hospital | Coos Bay | Oregon | United States | 97420 |
| 359 | Providence Newberg Medical Center | Newberg | Oregon | United States | 97132 |
| 360 | Saint Alphonsus Medical Center-Ontario | Ontario | Oregon | United States | 97914 |
| 361 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 362 | Providence Saint Vincent Medical Center | Portland | Oregon | United States | 97225 |
| 363 | Saint Charles Health System-Redmond | Redmond | Oregon | United States | 97756 |
| 364 | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | United States | 18103 |
| 365 | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | United States | 18017 |
| 366 | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | United States | 19317 |
| 367 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 368 | Pocono Medical Center | East Stroudsburg | Pennsylvania | United States | 18301 |
| 369 | Ephrata Cancer Center | Ephrata | Pennsylvania | United States | 17522 |
| 370 | Ephrata Community Hospital | Ephrata | Pennsylvania | United States | 17522 |
| 371 | Adams Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
| 372 | Cherry Tree Cancer Center | Hanover | Pennsylvania | United States | 17331 |
| 373 | UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | United States | 17101 |
| 374 | UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania | United States | 17109 |
| 375 | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | United States | 18201 |
| 376 | Lehigh Valley Hospital-Hazleton | Hazleton | Pennsylvania | United States | 18201 |
| 377 | Sechler Family Cancer Center | Lebanon | Pennsylvania | United States | 17042 |
| 378 | Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | United States | 17837 |
| 379 | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | United States | 15232 |
| 380 | Geisinger Cancer Services-Pottsville | Pottsville | Pennsylvania | United States | 17901 |
| 381 | Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania | United States | 18840 |
| 382 | Community Medical Center | Scranton | Pennsylvania | United States | 18510 |
| 383 | Geisinger Medical Oncology-Selinsgrove | Selinsgrove | Pennsylvania | United States | 17870 |
| 384 | Geisinger Medical Group | State College | Pennsylvania | United States | 16801 |
| 385 | Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
| 386 | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 387 | UPMC Susquehanna | Williamsport | Pennsylvania | United States | 17701 |
| 388 | WellSpan Health-York Cancer Center | York | Pennsylvania | United States | 17403 |
| 389 | WellSpan Health-York Hospital | York | Pennsylvania | United States | 17403 |
| 390 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 391 | Lexington Medical Center | West Columbia | South Carolina | United States | 29169 |
| 392 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
| 393 | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | United States | 57104 |
| 394 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 395 | Farmington Health Center | Farmington | Utah | United States | 84025 |
| 396 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
| 397 | South Jordan Health Center | South Jordan | Utah | United States | 84009 |
| 398 | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont | United States | 05602 |
| 399 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 400 | University of Vermont and State Agricultural College | Burlington | Vermont | United States | 05405 |
| 401 | Centra Lynchburg Hematology-Oncology Clinic Inc | Lynchburg | Virginia | United States | 24501 |
| 402 | Sovah Health Martinsville | Martinsville | Virginia | United States | 24115 |
| 403 | Bon Secours Memorial Regional Medical Center | Mechanicsville | Virginia | United States | 23116 |
| 404 | Bon Secours Saint Francis Medical Center | Midlothian | Virginia | United States | 23114 |
| 405 | Bon Secours DePaul Medical Center | Norfolk | Virginia | United States | 23505 |
| 406 | Bon Secours Saint Mary's Hospital | Richmond | Virginia | United States | 23226 |
| 407 | Bon Secours Cancer Institute at Reynolds Crossing | Richmond | Virginia | United States | 23230 |
| 408 | Virginia Cancer Institute | Richmond | Virginia | United States | 23230 |
| 409 | VCU Massey Cancer Center at Stony Point | Richmond | Virginia | United States | 23235 |
| 410 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 411 | VCU Community Memorial Health Center | South Hill | Virginia | United States | 23970 |
| 412 | Bon Secours Health Center at Harbour View | Suffolk | Virginia | United States | 23435 |
| 413 | Shenandoah Oncology PC | Winchester | Virginia | United States | 22601 |
| 414 | Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | United States | 98520 |
| 415 | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | United States | 98225 |
| 416 | Providence Regional Cancer System-Centralia | Centralia | Washington | United States | 98531 |
| 417 | Swedish Cancer Institute-Edmonds | Edmonds | Washington | United States | 98026 |
| 418 | Providence Regional Cancer Partnership | Everett | Washington | United States | 98201 |
| 419 | Swedish Cancer Institute-Issaquah | Issaquah | Washington | United States | 98029 |
| 420 | Kadlec Clinic Hematology and Oncology | Kennewick | Washington | United States | 99336 |
| 421 | Providence Regional Cancer System-Lacey | Lacey | Washington | United States | 98503 |
| 422 | PeaceHealth Saint John Medical Center | Longview | Washington | United States | 98632 |
| 423 | Valley Medical Center | Renton | Washington | United States | 98055 |
| 424 | Pacific Gynecology Specialists | Seattle | Washington | United States | 98104 |
| 425 | Swedish Medical Center-Ballard Campus | Seattle | Washington | United States | 98107 |
| 426 | Kaiser Permanente Washington | Seattle | Washington | United States | 98112 |
| 427 | Swedish Medical Center-First Hill | Seattle | Washington | United States | 98122-4307 |
| 428 | Swedish Medical Center-Cherry Hill | Seattle | Washington | United States | 98122-5711 |
| 429 | PeaceHealth United General Medical Center | Sedro-Woolley | Washington | United States | 98284 |
| 430 | Providence Regional Cancer System-Shelton | Shelton | Washington | United States | 98584 |
| 431 | PeaceHealth Southwest Medical Center | Vancouver | Washington | United States | 98664 |
| 432 | Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | United States | 99362 |
| 433 | Providence Regional Cancer System-Yelm | Yelm | Washington | United States | 98597 |
| 434 | Duluth Clinic Ashland | Ashland | Wisconsin | United States | 54806 |
| 435 | Northwest Wisconsin Cancer Center | Ashland | Wisconsin | United States | 54806 |
| 436 | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | United States | 54729 |
| 437 | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | United States | 54701 |
| 438 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 439 | Marshfield Clinic - Ladysmith Center | Ladysmith | Wisconsin | United States | 54848 |
| 440 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
| 441 | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | United States | 54548 |
| 442 | Cancer Center of Western Wisconsin | New Richmond | Wisconsin | United States | 54017 |
| 443 | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | United States | 54868 |
| 444 | Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin | United States | 54482 |
| 445 | Marshfield Clinic-Wausau Center | Wausau | Wisconsin | United States | 54401 |
| 446 | Marshfield Clinic - Weston Center | Weston | Wisconsin | United States | 54476 |
| 447 | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | United States | 54494 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Mina Sedrak, MD, MS, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT03633331
Other Study ID Numbers:
- A171601
- NCI-2017-01596
First Posted:
Aug 16, 2018
Last Update Posted:
Oct 15, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment (Palbociclib, Letrozole or Fulvestrant) |
|---|---|
| Arm/Group Description | Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies> > Quality-of-Life Assessment: Ancillary studies |
| Period Title: Overall Study | |
| STARTED | 93 |
| COMPLETED | 92 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Treatment (Palbociclib, Letrozole or Fulvestrant) |
|---|---|
| Arm/Group Description | Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies> > Quality-of-Life Assessment: Ancillary studies |
| Overall Participants | 93 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
74
|
| Sex: Female, Male (Count of Participants) | |
| Female |
92
98.9%
|
| Male |
1
1.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
3
3.2%
|
| Not Hispanic or Latino |
88
94.6%
|
| Unknown or Not Reported |
2
2.2%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
1.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
4
4.3%
|
| White |
85
91.4%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
3.2%
|
Outcome Measures
| Title | Incidence of Adverse Events |
|---|---|
| Description | Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| patients meeting the eligibility criteria who have not withdrawn before treatment and have adverse event data available are considered evaluable for the primary endpoint. |
| Arm/Group Title | Treatment (Palbociclib, Letrozole or Fulvestrant) |
|---|---|
| Arm/Group Description | Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies> > Quality-of-Life Assessment: Ancillary studies |
| Measure Participants | 90 |
| Number (95% Confidence Interval) [proportion of patients] |
0.756
|
| Title | Incidence of Drug Toxicities - Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0 |
|---|---|
| Description | Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0 |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Dose Reduction, Dose Hold, and Hospitalization Reasons |
|---|---|
| Description | A 95% binomial confidence interval for single proportions will be constructed for the percentage of patients that had at least one dose reduction, dose hold, or hospitalization within the first year of treatment. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Time to Treatment Failure (and Reason for Coming Off Study - Toxicity, Patient Preference, Progression) |
|---|---|
| Description | Distributions time to treatment failure will be estimated using Kaplan-Meier methodology. Treatment failure is defined as a severe adverse event, disease progression or patient refusal to continue assigned treatment. Any reason that treatment is discontinued to time to treatment failure and not censor patients will be included. The reason for treatment discontinuation will be captured. |
| Time Frame | Up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Palbociclib Adherence Rate |
|---|---|
| Description | Patients to be included in the analysis cohort will be those patients who have taken one or more doses of the study treatment. Those patients will be considered adherent to study treatment. For each of the first 3 cycles, an estimate of the proportion of patients who meet the criteria for adherence and its corresponding 95% confidence interval will be determined. |
| Time Frame | Up to 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) |
|---|---|
| Description | The response rate is defined as the proportion of patients whose disease status met Response Evaluation Criteria in Solid Tumors (RECIST) criteria for complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 8 weeks apart. A 95% binomial confidence interval for the response rate will be constructed. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | Distributions of progression free survival (PFS) times will be estimated using Kaplan-Meier methodology. |
| Time Frame | From start of treatment to the first of the following disease events: local/regional/distant recurrence, invasive contralateral breast disease, second primary or death due to any cause, assessed up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Overall Survival (OS) |
|---|---|
| Description | Distributions of overall survival (OS) times will be estimated using Kaplan-Meier methodology. |
| Time Frame | Up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Overall Treatment Utility (OTU) Results |
|---|---|
| Description | OTU is a novel composite endpoint developed by investigators of the FOCUS2 trial to assess the outcome of palliative chemotherapy. The patient will be given either an overall score of "good", "intermediate", or "poor". A 95% binomial confidence interval will be constructed for the percentage of patients that scored "good" on the OTU. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Sarcopenia Analysis |
|---|---|
| Description | Will examine variables associated with skeletal muscle loss during treatment and whether skeletal muscle loss during treatment is associated with the presence of grade 3-5 toxicity and adverse events. Sarcopenia will be treated as a binary variable using the Skeletal Muscle Index (SMI) (SMI < 41 cm^2/m^2 vs. SMI > 41 cm^2/m^2) and differences in grades chemotherapy toxicity and adverse events will be analyzed using two group t-tests and fisher's exact test. The number of patients with and without sarcopenia grouped by patients with or without grade 3+ Adverse Events (AE's) will be also be reported. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Quality of Life as Measured by the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) |
|---|---|
| Description | European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) is comprised of 5 dimensions. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, no problems, some problems, extreme problems. The EQ-5D-3L can be converted to a single summary index. The median and range of this total score will be reported. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 6 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Treatment (Palbociclib, Letrozole or Fulvestrant) | |
| Arm/Group Description | Quality-of-Life Assessment: Ancillary studies | |
All Cause Mortality |
||
| Treatment (Palbociclib, Letrozole or Fulvestrant) | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/92 (4.3%) | |
Serious Adverse Events |
||
| Treatment (Palbociclib, Letrozole or Fulvestrant) | ||
| Affected / at Risk (%) | # Events | |
| Total | 35/92 (38%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 6/92 (6.5%) | 19 |
| Febrile neutropenia | 1/92 (1.1%) | 1 |
| Cardiac disorders | ||
| Cardiac arrest | 1/92 (1.1%) | 2 |
| Eye disorders | ||
| Eye disorders - Other, specify | 1/92 (1.1%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 2/92 (2.2%) | 2 |
| Ascites | 1/92 (1.1%) | 1 |
| Diarrhea | 2/92 (2.2%) | 8 |
| Dysphagia | 1/92 (1.1%) | 1 |
| Enterocolitis | 1/92 (1.1%) | 1 |
| Gastric hemorrhage | 1/92 (1.1%) | 5 |
| Mucositis oral | 2/92 (2.2%) | 3 |
| Nausea | 5/92 (5.4%) | 7 |
| Vomiting | 2/92 (2.2%) | 2 |
| General disorders | ||
| Chills | 1/92 (1.1%) | 2 |
| Death NOS | 1/92 (1.1%) | 1 |
| Fatigue | 6/92 (6.5%) | 10 |
| Fever | 1/92 (1.1%) | 1 |
| Flu like symptoms | 1/92 (1.1%) | 1 |
| Gen disord and admin site conds-Oth spec | 1/92 (1.1%) | 1 |
| Non-cardiac chest pain | 2/92 (2.2%) | 5 |
| Hepatobiliary disorders | ||
| Hepatic failure | 1/92 (1.1%) | 1 |
| Immune system disorders | ||
| Allergic reaction | 1/92 (1.1%) | 1 |
| Infections and infestations | ||
| Lung infection | 1/92 (1.1%) | 1 |
| Sepsis | 1/92 (1.1%) | 1 |
| Upper respiratory infection | 1/92 (1.1%) | 1 |
| Urinary tract infection | 1/92 (1.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Hip fracture | 1/92 (1.1%) | 1 |
| Investigations | ||
| Alanine aminotransferase increased | 1/92 (1.1%) | 1 |
| Aspartate aminotransferase increased | 1/92 (1.1%) | 1 |
| Creatinine increased | 1/92 (1.1%) | 2 |
| Neutrophil count decreased | 10/92 (10.9%) | 25 |
| Platelet count decreased | 3/92 (3.3%) | 7 |
| White blood cell decreased | 8/92 (8.7%) | 19 |
| Metabolism and nutrition disorders | ||
| Anorexia | 1/92 (1.1%) | 4 |
| Hyperglycemia | 1/92 (1.1%) | 1 |
| Hyperphosphatemia | 1/92 (1.1%) | 1 |
| Hypoalbuminemia | 1/92 (1.1%) | 1 |
| Hypocalcemia | 1/92 (1.1%) | 2 |
| Hypokalemia | 1/92 (1.1%) | 1 |
| Hypophosphatemia | 1/92 (1.1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/92 (1.1%) | 2 |
| Back pain | 2/92 (2.2%) | 2 |
| Generalized muscle weakness | 3/92 (3.3%) | 3 |
| Muscle cramp | 1/92 (1.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Neoplasms benign, mal, uncpec - Oth spec | 1/92 (1.1%) | 1 |
| Nervous system disorders | ||
| Peripheral motor neuropathy | 1/92 (1.1%) | 1 |
| Peripheral sensory neuropathy | 1/92 (1.1%) | 4 |
| Stroke | 1/92 (1.1%) | 1 |
| Psychiatric disorders | ||
| Confusion | 1/92 (1.1%) | 1 |
| Insomnia | 1/92 (1.1%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/92 (1.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 5/92 (5.4%) | 6 |
| Hypoxia | 1/92 (1.1%) | 1 |
| Pleural effusion | 1/92 (1.1%) | 1 |
| Pneumothorax | 1/92 (1.1%) | 1 |
| Productive cough | 1/92 (1.1%) | 1 |
| Resp, thoracic, mediastinal - Oth spec | 1/92 (1.1%) | 1 |
| Respiratory failure | 1/92 (1.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Dry skin | 1/92 (1.1%) | 2 |
| Surgical and medical procedures | ||
| Surgical and medical proced - Oth spec | 1/92 (1.1%) | 1 |
| Vascular disorders | ||
| Hot flashes | 1/92 (1.1%) | 2 |
| Hypertension | 2/92 (2.2%) | 3 |
| Thromboembolic event | 1/92 (1.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Treatment (Palbociclib, Letrozole or Fulvestrant) | ||
| Affected / at Risk (%) | # Events | |
| Total | 92/92 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 72/92 (78.3%) | 549 |
| Blood and lymph sys disorders - Oth Spec | 3/92 (3.3%) | 39 |
| Febrile neutropenia | 2/92 (2.2%) | 2 |
| Cardiac disorders | ||
| Atrial fibrillation | 2/92 (2.2%) | 19 |
| Cardiac disorders - Other, specify | 3/92 (3.3%) | 3 |
| Chest pain - cardiac | 3/92 (3.3%) | 13 |
| Heart failure | 1/92 (1.1%) | 20 |
| Mobitz (type) II atrioventricular block | 1/92 (1.1%) | 1 |
| Palpitations | 1/92 (1.1%) | 2 |
| Sinus bradycardia | 2/92 (2.2%) | 2 |
| Ear and labyrinth disorders | ||
| Ear pain | 1/92 (1.1%) | 4 |
| Hearing impaired | 2/92 (2.2%) | 5 |
| Vertigo | 2/92 (2.2%) | 5 |
| Endocrine disorders | ||
| Endocrine disorders - Other, specify | 1/92 (1.1%) | 1 |
| Hypothyroidism | 3/92 (3.3%) | 44 |
| Eye disorders | ||
| Blurred vision | 6/92 (6.5%) | 54 |
| Cataract | 2/92 (2.2%) | 17 |
| Dry eye | 3/92 (3.3%) | 5 |
| Eye disorders - Other, specify | 3/92 (3.3%) | 8 |
| Eye pain | 1/92 (1.1%) | 2 |
| Watering eyes | 2/92 (2.2%) | 22 |
| Gastrointestinal disorders | ||
| Abdominal distension | 1/92 (1.1%) | 6 |
| Abdominal pain | 3/92 (3.3%) | 9 |
| Bloating | 2/92 (2.2%) | 3 |
| Cheilitis | 1/92 (1.1%) | 1 |
| Colitis | 1/92 (1.1%) | 1 |
| Constipation | 17/92 (18.5%) | 63 |
| Dental caries | 1/92 (1.1%) | 1 |
| Diarrhea | 40/92 (43.5%) | 214 |
| Dry mouth | 10/92 (10.9%) | 53 |
| Dyspepsia | 7/92 (7.6%) | 39 |
| Dysphagia | 4/92 (4.3%) | 16 |
| Esophageal pain | 1/92 (1.1%) | 1 |
| Fecal incontinence | 2/92 (2.2%) | 10 |
| Flatulence | 1/92 (1.1%) | 1 |
| Gastroesophageal reflux disease | 9/92 (9.8%) | 35 |
| Gastrointestinal disorders - Oth spec | 3/92 (3.3%) | 3 |
| Mucositis oral | 30/92 (32.6%) | 135 |
| Nausea | 40/92 (43.5%) | 153 |
| Oral hemorrhage | 1/92 (1.1%) | 1 |
| Oral pain | 2/92 (2.2%) | 2 |
| Rectal pain | 1/92 (1.1%) | 1 |
| Toothache | 1/92 (1.1%) | 2 |
| Vomiting | 14/92 (15.2%) | 25 |
| General disorders | ||
| Chills | 6/92 (6.5%) | 8 |
| Edema face | 1/92 (1.1%) | 1 |
| Edema limbs | 8/92 (8.7%) | 32 |
| Fatigue | 78/92 (84.8%) | 716 |
| Fever | 4/92 (4.3%) | 5 |
| Flu like symptoms | 1/92 (1.1%) | 1 |
| Gait disturbance | 2/92 (2.2%) | 6 |
| Gen disord and admin site conds-Oth spec | 1/92 (1.1%) | 1 |
| Injection site reaction | 3/92 (3.3%) | 10 |
| Localized edema | 1/92 (1.1%) | 7 |
| Malaise | 1/92 (1.1%) | 1 |
| Non-cardiac chest pain | 1/92 (1.1%) | 9 |
| Pain | 19/92 (20.7%) | 44 |
| Immune system disorders | ||
| Allergic reaction | 1/92 (1.1%) | 1 |
| Infections and infestations | ||
| Bone infection | 1/92 (1.1%) | 4 |
| Bronchial infection | 1/92 (1.1%) | 1 |
| Eye infection | 1/92 (1.1%) | 1 |
| Infections and infestations - Oth spec | 3/92 (3.3%) | 3 |
| Lip infection | 1/92 (1.1%) | 7 |
| Mucosal infection | 1/92 (1.1%) | 16 |
| Otitis externa | 1/92 (1.1%) | 4 |
| Otitis media | 1/92 (1.1%) | 1 |
| Papulopustular rash | 1/92 (1.1%) | 1 |
| Sepsis | 1/92 (1.1%) | 1 |
| Sinusitis | 2/92 (2.2%) | 4 |
| Skin infection | 2/92 (2.2%) | 4 |
| Tooth infection | 1/92 (1.1%) | 1 |
| Upper respiratory infection | 9/92 (9.8%) | 10 |
| Urinary tract infection | 7/92 (7.6%) | 8 |
| Wound infection | 1/92 (1.1%) | 3 |
| Injury, poisoning and procedural complications | ||
| Bruising | 5/92 (5.4%) | 11 |
| Burn | 1/92 (1.1%) | 2 |
| Dermatitis radiation | 2/92 (2.2%) | 2 |
| Fall | 6/92 (6.5%) | 6 |
| Fracture | 4/92 (4.3%) | 4 |
| Spinal fracture | 1/92 (1.1%) | 2 |
| Investigations | ||
| Alanine aminotransferase increased | 14/92 (15.2%) | 49 |
| Alkaline phosphatase increased | 7/92 (7.6%) | 29 |
| Aspartate aminotransferase increased | 12/92 (13%) | 45 |
| Blood bilirubin increased | 1/92 (1.1%) | 6 |
| Blood lactate dehydrogenase increased | 1/92 (1.1%) | 14 |
| CD4 lymphocytes decreased | 1/92 (1.1%) | 1 |
| Cholesterol high | 1/92 (1.1%) | 1 |
| Creatinine increased | 20/92 (21.7%) | 66 |
| Investigations - Other, specify | 4/92 (4.3%) | 15 |
| Lymphocyte count decreased | 26/92 (28.3%) | 96 |
| Neutrophil count decreased | 85/92 (92.4%) | 885 |
| Platelet count decreased | 61/92 (66.3%) | 379 |
| Weight gain | 1/92 (1.1%) | 6 |
| Weight loss | 4/92 (4.3%) | 10 |
| White blood cell decreased | 80/92 (87%) | 897 |
| Metabolism and nutrition disorders | ||
| Anorexia | 28/92 (30.4%) | 96 |
| Dehydration | 4/92 (4.3%) | 5 |
| Glucose intolerance | 1/92 (1.1%) | 6 |
| Hypercalcemia | 4/92 (4.3%) | 15 |
| Hyperglycemia | 22/92 (23.9%) | 104 |
| Hyperkalemia | 1/92 (1.1%) | 5 |
| Hyperlipidemia | 2/92 (2.2%) | 38 |
| Hypernatremia | 2/92 (2.2%) | 4 |
| Hyperphosphatemia | 2/92 (2.2%) | 2 |
| Hypertriglyceridemia | 1/92 (1.1%) | 6 |
| Hypoalbuminemia | 6/92 (6.5%) | 15 |
| Hypocalcemia | 11/92 (12%) | 25 |
| Hypoglycemia | 2/92 (2.2%) | 2 |
| Hypokalemia | 6/92 (6.5%) | 15 |
| Hypomagnesemia | 2/92 (2.2%) | 8 |
| Hyponatremia | 7/92 (7.6%) | 22 |
| Hypophosphatemia | 2/92 (2.2%) | 2 |
| Metabolism, nutrition disord - Oth spec | 1/92 (1.1%) | 1 |
| Obesity | 1/92 (1.1%) | 17 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 21/92 (22.8%) | 107 |
| Arthritis | 1/92 (1.1%) | 17 |
| Back pain | 24/92 (26.1%) | 129 |
| Bone pain | 6/92 (6.5%) | 31 |
| Buttock pain | 1/92 (1.1%) | 1 |
| Chest wall pain | 2/92 (2.2%) | 6 |
| Generalized muscle weakness | 8/92 (8.7%) | 19 |
| Joint range of motion decreased | 1/92 (1.1%) | 5 |
| Muscle cramp | 3/92 (3.3%) | 11 |
| Muscle weakness lower limb | 1/92 (1.1%) | 1 |
| Musculoskeletal, conn tissue - Oth spec | 2/92 (2.2%) | 3 |
| Myalgia | 12/92 (13%) | 43 |
| Neck pain | 3/92 (3.3%) | 7 |
| Osteoporosis | 1/92 (1.1%) | 17 |
| Pain in extremity | 16/92 (17.4%) | 59 |
| Nervous system disorders | ||
| Ataxia | 1/92 (1.1%) | 7 |
| Cognitive disturbance | 1/92 (1.1%) | 8 |
| Dizziness | 7/92 (7.6%) | 12 |
| Dysgeusia | 8/92 (8.7%) | 21 |
| Headache | 9/92 (9.8%) | 16 |
| Memory impairment | 3/92 (3.3%) | 15 |
| Nervous system disorders - Oth spec | 2/92 (2.2%) | 2 |
| Neuralgia | 1/92 (1.1%) | 15 |
| Peripheral motor neuropathy | 2/92 (2.2%) | 6 |
| Peripheral sensory neuropathy | 36/92 (39.1%) | 315 |
| Tremor | 3/92 (3.3%) | 10 |
| Vasovagal reaction | 1/92 (1.1%) | 1 |
| Psychiatric disorders | ||
| Agitation | 1/92 (1.1%) | 16 |
| Anxiety | 7/92 (7.6%) | 20 |
| Confusion | 3/92 (3.3%) | 6 |
| Depression | 10/92 (10.9%) | 15 |
| Insomnia | 13/92 (14.1%) | 72 |
| Irritability | 1/92 (1.1%) | 1 |
| Personality change | 1/92 (1.1%) | 3 |
| Renal and urinary disorders | ||
| Chronic kidney disease | 3/92 (3.3%) | 27 |
| Dysuria (painful urination) | 1/92 (1.1%) | 5 |
| Glucosuria | 1/92 (1.1%) | 1 |
| Hematuria | 2/92 (2.2%) | 2 |
| Renal and urinary disorders - Oth spec | 4/92 (4.3%) | 5 |
| Urinary frequency | 3/92 (3.3%) | 15 |
| Urinary incontinence | 2/92 (2.2%) | 2 |
| Urinary retention | 1/92 (1.1%) | 1 |
| Urinary tract obstruction | 1/92 (1.1%) | 1 |
| Reproductive system and breast disorders | ||
| Breast pain | 1/92 (1.1%) | 1 |
| Pelvic pain | 2/92 (2.2%) | 6 |
| Vaginal discharge | 1/92 (1.1%) | 2 |
| Vaginal dryness | 1/92 (1.1%) | 8 |
| Respiratory, thoracic and mediastinal disorders | ||
| Allergic rhinitis | 3/92 (3.3%) | 20 |
| Cough | 12/92 (13%) | 37 |
| Dyspnea | 15/92 (16.3%) | 73 |
| Hiccups | 2/92 (2.2%) | 8 |
| Hypoxia | 1/92 (1.1%) | 1 |
| Nasal congestion | 1/92 (1.1%) | 1 |
| Pleural effusion | 1/92 (1.1%) | 1 |
| Postnasal drip | 1/92 (1.1%) | 1 |
| Productive cough | 1/92 (1.1%) | 1 |
| Rhinorrhea | 1/92 (1.1%) | 1 |
| Voice alteration | 1/92 (1.1%) | 2 |
| Wheezing | 1/92 (1.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 27/92 (29.3%) | 102 |
| Dry skin | 14/92 (15.2%) | 58 |
| Hyperhidrosis | 2/92 (2.2%) | 16 |
| Nail changes | 3/92 (3.3%) | 8 |
| Nail ridging | 1/92 (1.1%) | 18 |
| Palmar-plantar erythrodysesthesia syndrm | 1/92 (1.1%) | 2 |
| Pruritus | 7/92 (7.6%) | 13 |
| Rash acneiform | 1/92 (1.1%) | 1 |
| Rash maculo-papular | 4/92 (4.3%) | 8 |
| Skin and subcut tissue disord - Oth spec | 2/92 (2.2%) | 3 |
| Surgical and medical procedures | ||
| Surgical and medical proced - Oth spec | 2/92 (2.2%) | 3 |
| Vascular disorders | ||
| Hot flashes | 17/92 (18.5%) | 92 |
| Hypertension | 21/92 (22.8%) | 138 |
| Hypotension | 3/92 (3.3%) | 12 |
| Lymphedema | 7/92 (7.6%) | 37 |
| Thromboembolic event | 5/92 (5.4%) | 13 |
| Vascular disorders - Other, specify | 2/92 (2.2%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE 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 | Mina S. Sedrak MD, MS |
|---|---|
| Organization | City of Hope Comprehensive Cancer Center |
| Phone | 626-218-4173 |
| msedrak@coh.org |
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT03633331
Other Study ID Numbers:
- A171601
- NCI-2017-01596
First Posted:
Aug 16, 2018
Last Update Posted:
Oct 15, 2021
Last Verified:
Sep 1, 2021