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
2 other identifiers
interventional
120
1 country
27
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2008
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
May 11, 2016
CompletedJune 13, 2016
May 1, 2016
5.8 years
June 10, 2008
March 9, 2016
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Secondary Outcomes (6)
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)
Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population
Day 1 to Study Completion (approximately 6 years)
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)
Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population
At 6 months and at 12 months
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)
- +1 more secondary outcomes
Study Arms (2)
A1
ACTIVE COMPARATORA2
ACTIVE COMPARATORInterventions
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- US Oncology Researchcollaborator
Study Sites (27)
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336, United States
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, 85704, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80220, United States
Florida Cancer Institute - New Hope
Hudson, Florida, 34667, United States
Central Indiana Cancer Centers
Carmel, Indiana, 46032, United States
New York Oncology Hematology, Pc
Troy, New York, 12180, United States
Dayton Oncology And Hematology
Kettering, Ohio, 45409, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists, Pc
Portland, Oregon, 97213, United States
Medical Oncology Associates
Kingston, Pennsylvania, 18704, United States
Texas Oncology-Central Austin Cancer Center
Austin, Texas, 78731, United States
Texas Oncology
Bedord, Texas, 76022, United States
Texas Cancer Center At Medical City
Dallas, Texas, 75230, United States
Texas Oncology
Dallas, Texas, 75231, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246, United States
El Paso Cancer Treatment Ctr - East
El Paso, Texas, 79915, United States
Texas Oncology
Fort Worth, Texas, 76104, United States
Texas Oncology
Garland, Texas, 75042, United States
Texas Oncology
Houston, Texas, 77024, United States
Texas Oncology-Plano East
Plano, Texas, 75075, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, 78217, United States
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Texas Oncology Cancer Care And Research Center
Waco, Texas, 76712, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
August 1, 2008
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 13, 2016
Results First Posted
May 11, 2016
Record last verified: 2016-05