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

Completed · Phase 2

Conditions studied: Advanced Breast Cancer

In brief

The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.

Key facts

Study ID

NCT00754325

Run by

Bristol-Myers Squibb

People needed

100

Starts

2008-09-01

Expected to finish

2014-01-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Pregnant or breast feeding
• >1 chemotherapy regimen for advanced disease
• Pleural or pericardial effusion
• Serious cardiac condition

Where it is running

• Northern Arizona Hematology & Oncology Associates — Sedona, Arizona, United States
• Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope — Tucson, Arizona, United States
• Florida Cancer Institute - New Hope — Hudson, Florida, United States
• Cancer Centers Of Florida, P.A — Ocoee, Florida, United States
• Central Indiana Cancer Centers — Carmel, Indiana, United States
• Kansas City Cancer Center, Llc. — Overland Park, Kansas, United States
• Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• New York Oncology Hematology, Pc — Troy, New York, United States
• Raleigh Hematology Oncology Associates — Raleigh, North Carolina, United States
• Willamette Valley Cancer Center — Eugene, Oregon, United States
• Northwest Cancer Specialists, P.C. — Portland, Oregon, United States
• Texas Oncology-Central Austin Cancer Center — Austin, Texas, United States
• Texas Oncology, P.A. — Bedford, Texas, United States
• Texas Oncology, P.A. — Dallas, Texas, United States
• Texas Oncology — Dallas, Texas, United States
• Texas Oncology Sammons Cancer Center — Dallas, Texas, United States
• Texas Cancer Center — Denton, Texas, United States
• El Paso Cancer Treatment Ctr - West — El Paso, Texas, United States
• Us Oncology Research, Inc. — Houston, Texas, United States
• Quest Diagnostic Clinical Laboratories Inc — Houston, Texas, United States
• Cancer Care Centers Of South Texas — San Antonio, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Texas Oncology Cancer Care And Research Center — Waco, Texas, United States
• Texas Oncology, P.A. — Webster, Texas, United States

Full record on ClinicalTrials.gov

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