Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

Completed · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone

Key facts

Study ID

NCT00696072

Run by

Bristol-Myers Squibb

People needed

120

Starts

2008-08-01

Expected to finish

2014-06-01

Last updated by the study team

2016-06-13

Who can join

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

You may qualify if…

• Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
• Has measurable or evaluable-only disease
• Is female, ≥18 yrs of age, post menopausal or surgically sterile
• HER2 negative, HR+, ER+ and/or PgR+ breast cancer
• 0-1 prior chemotherapy regimen for metastatic disease.
• Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
• Prior tamoxifen therapy is allowed
• No AI therapy for >1 year without recurrence

You may not qualify if…

• Pregnant or breast feeding
• Prior hormonal therapy for metastatic or locally recurrent disease
• >1 chemotherapy regimen for metastatic disease
• Pleural or pericardial effusion
• Serious cardiac condition

Where it is running

• Northern Arizona Hematology & Oncology Associates — Sedona, Arizona, United States
• Arizona Oncology Associates D.B.A. Hematology Oncology — Tucson, Arizona, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Florida Cancer Institute - New Hope — Hudson, Florida, United States
• Central Indiana Cancer Centers — Carmel, Indiana, United States
• New York Oncology Hematology, Pc — Troy, New York, United States
• Dayton Oncology And Hematology — Kettering, Ohio, United States
• Willamette Valley Cancer Center — Eugene, Oregon, United States
• Northwest Cancer Specialists, Pc — Portland, Oregon, United States
• Medical Oncology Associates — Kingston, Pennsylvania, United States
• Texas Oncology-Central Austin Cancer Center — Austin, Texas, United States
• Texas Oncology — Bedord, Texas, United States
• Texas Cancer Center At Medical City — Dallas, Texas, United States
• Texas Oncology — Dallas, Texas, United States
• Texas Oncology Sammons Cancer Center — Dallas, Texas, United States
• El Paso Cancer Treatment Ctr - East — El Paso, Texas, United States
• Texas Oncology — Fort Worth, Texas, United States
• Texas Oncology — Garland, Texas, United States
• Texas Oncology — Houston, Texas, United States
• Texas Oncology-Plano East — Plano, Texas, United States
• Cancer Care Centers Of South Texas — San Antonio, Texas, United States
• Texas Oncology Cancer Center - Sugar Land — Sugar Land, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Texas Oncology Cancer Care And Research Center — Waco, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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