Metastatic Breast Cancer Clinical Trial
Official title:
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
| Verified date | May 2015 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com. Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Oncology-Central Austin Cancer Center | Austin | Texas |
| United States | Texas Oncology | Bedord | Texas |
| United States | Central Indiana Cancer Centers | Carmel | Indiana |
| 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 | Rocky Mountain Cancer Centers | Denver | Colorado |
| United States | El Paso Cancer Treatment Ctr - East | El Paso | Texas |
| United States | Willamette Valley Cancer Center | Eugene | Oregon |
| United States | Texas Oncology | Fort Worth | Texas |
| United States | Texas Oncology | Garland | Texas |
| United States | Texas Oncology | Houston | Texas |
| United States | Florida Cancer Institute - New Hope | Hudson | Florida |
| United States | Dayton Oncology And Hematology | Kettering | Ohio |
| United States | Medical Oncology Associates | Kingston | Pennsylvania |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Texas Oncology-Plano East | Plano | Texas |
| United States | Northwest Cancer Specialists, Pc | Portland | Oregon |
| United States | Oncology & Hematology Associates Of Southwest Virginia, Inc. | Salem | Virginia |
| United States | Cancer Care Centers Of South Texas | San Antonio | Texas |
| United States | Northern Arizona Hematology & Oncology Associates | Sedona | Arizona |
| United States | Texas Oncology Cancer Center - Sugar Land | Sugar Land | Texas |
| United States | New York Oncology Hematology, Pc | Troy | New York |
| United States | Arizona Oncology Associates D.B.A. Hematology Oncology | Tucson | Arizona |
| United States | Tyler Cancer Center | Tyler | Texas |
| United States | Texas Oncology Cancer Care And Research Center | Waco | Texas |
| United States | Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | US Oncology Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the clinical benefit rate with letrozole or with letrozole plus dasatinib | (CBR equal to CR+PR+SD =6 months) | No | |
| Secondary | Overall response rate in patients who receive letrozole plus dasatinib or single-agent letrozole | at 2 years | No | |
| Secondary | Median PFS in patients in both Arms | at 6 and 12 months | No | |
| Secondary | Overall response rate & CBR in patients who crossover to either Arm 1b or Arm 2b | at 2 years | No | |
| Secondary | PFS for both treatment arms | at 6- and 12-months | No | |
| Secondary | Time to treatment failure (TTF) | at 6 months and 1 year | No | |
| Secondary | Changes in bone markers | at 6 months and 1 year | No | |
| Secondary | Toxicity | at each clinic visit | Yes | |
| Secondary | Effect on bone pain | at each clinic visit | No | |
| Secondary | Bone Mineral Density changes | between baseline and 6 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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