Phase II Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Breast Cancer
Both
Advanced Breast Cancer
Trial Information
Phase II Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
Inclusion Criteria:
- Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+)
and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry
(IHC)
- Measureable or evaluable-only disease
- human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer
- Males and females ≥18 years of age
- Females are post menopausal or surgically sterile
- Recurrent or progressive advanced breast cancer (locally-advanced or metastatic),
that has progressed: (a) during or within 12 months after completion of adjuvant
Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting
(metastatic therapy)
Exclusion Criteria:
- Pregnant or breast feeding
- >1 chemotherapy regimen for advanced disease
- Pleural or pericardial effusion
- Serious cardiac condition
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To estimate progression-free survival (PFS) distribution of subjects with advanced breast cancer treated with either fulvestrant plus dasatinib or single-agent fulvestrant
Outcome Time Frame:
6 months and 12 months
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA180-158
NCT ID:
NCT00754325
Start Date:
September 2008
Completion Date:
December 2012
Related Keywords:
- Advanced Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| Virginia Oncology Associates | Newport News, Virginia 23606 |
| Missouri Cancer Associates | Columbia, Missouri 65201 |
| Tyler Cancer Center | Tyler, Texas 75702 |
| Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
| Texas Oncology | Dallas, Texas |
| Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
| Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
| Texas Cancer Center | Abilene, Texas 79606 |
| Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
| Northern Arizona Hematology & Oncology Associates | Sedona, Arizona 86336 |
| New York Oncology Hematology, PC | Albany, New York 12208 |
| Oncology & Hematology Associates of Southwest Virginia, Inc. | Salem, Virginia 24153 |
| Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
| Northwest Cancer Specialists, P.C. | Portland, Oregon 97227 |
| Texas Oncology Cancer Care and Research Center | Waco, Texas 76712 |
| Florida Cancer Institute - New Hope | New Port Richey, Florida 34655 |
| US Oncology Research, Inc. | Dallas, Texas 75204 |
| Cancer Centers Of Florida, P.A | Ocoee, Florida 34761 |
| Texas Oncology Sammons Cancer Center | Dallas, Texas 75246 |
| Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope | Tucson, Arizona 85704 |
| Kansas City Cancer Center, Llc. | Overland Park, Kansas 66210 |
| Texas Oncology-Austin Central | Austin, Texas 78731 |
| El Paso Cancer Treatment Ctr - West | El Paso, Texas 79902 |
| Virginia Center Specialists, Pc | Fairfax, Virginia 22031 |
