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
- Registration Number
- NCT00696072
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 Dasatinib - A1 Letrozole - A2 Letrozole -
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population At 6 months and at 12 months Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants.
Median Time to Treatment Failure (TTF) - ITT Population First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.
Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population Day 1 to Study Completion (approximately 6 years) PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014.
Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years) AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Trial Locations
- Locations (23)
Florida Cancer Institute - New Hope
🇺🇸Hudson, Florida, United States
Arizona Oncology Associates D.B.A. Hematology Oncology
🇺🇸Tucson, Arizona, 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
🇺🇸Houston, Texas, United States
Texas Cancer Center At Medical City
🇺🇸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-Plano East
🇺🇸Plano, Texas, United States
Texas Oncology Cancer Center - Sugar Land
🇺🇸Sugar Land, Texas, United States
Cancer Care Centers Of South Texas
🇺🇸San Antonio, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Yakima Valley Memorial Hospital/North Star Lodge
🇺🇸Yakima, Washington, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
🇺🇸Salem, Virginia, United States
Northern Arizona Hematology & Oncology Associates
🇺🇸Sedona, Arizona, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Texas Oncology Cancer Care And Research Center
🇺🇸Waco, Texas, United States