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Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
A Phase 2 Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Hormone Receptor-Positive Breast Cancer Subjects With Acquired Resistance to Non-Steroidal Aromatase Inhibitors
1 other identifier
interventional
77
1 country
21
Brief Summary
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Dec 2010
21 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
October 19, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedStudy Start
First participant enrolled
December 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2014
CompletedResults Posted
Study results publicly available
July 11, 2019
CompletedAugust 11, 2020
August 1, 2020
3.9 years
October 19, 2010
March 21, 2019
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival Rate at 24 Weeks
Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study.
24 weeks after initiation of study treatment
Secondary Outcomes (7)
The Objective Response Rate (ORR) in Participants With Measurable Disease
24 weeks after initiation of study treatment
Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths
Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months
Duration of Response (DOR) in Participants With Measurable Disease
24 weeks after initiation of study treatment
Number of On-study Laboratory Abnormalities: Grade 1-2
Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)
Number of On-study Laboratory Abnormalities: Grade 3-4
Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)
- +2 more secondary outcomes
Study Arms (2)
BMS-754807
EXPERIMENTALBMS-754807 + letrozole
EXPERIMENTALInterventions
Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity
Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer
- Disease progression following non-steroidal aromatase inhibitor treatment
You may not qualify if:
- Known symptomatic brain metastasis
- Medical condition requiring chronic steroids
- History of Type 1 or 2 Diabetes
- Uncontrolled or significant cardiovascular (CV) disease
- Concomitant second malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Mayo Cliniccollaborator
Study Sites (21)
Univ Of Al At Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
University Of Chicago Medical Center
Chicago, Illinois, 60637, United States
Illinois Cancercare, Pc
Peoria, Illinois, 61615, United States
Indiana University Health Goshen Center For Cancer Care
Goshen, Indiana, 46526, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231-1000, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231, United States
Oncology Care Associates, P.A.
Wheaton, Maryland, 20902, United States
Masonic Cancer Ctr, University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Unv. Of Nc At Chapel Hill
Chapel Hill, North Carolina, 27599-7305, United States
Unv. Of Nc At Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Presbyterian Hospital Cancer Research
Charlotte, North Carolina, 28204, United States
Duke University Medical Center-Dept Of Medicine
Durham, North Carolina, 27710, United States
Ut Md Anderson Can Ctr.
Houston, Texas, 77030-4009, United States
Ut Md Anderson Can Ctr.
Houston, Texas, 77030, United States
University Of Virginia Health System
Charlottesville, Virginia, 22908, United States
University Of Wisconsin
Madison, Wisconsin, 53792-6164, United States
University Of Wisconsin
Madison, Wisconsin, 53792, 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
October 19, 2010
First Posted
October 20, 2010
Study Start
December 31, 2010
Primary Completion
November 30, 2014
Study Completion
November 30, 2014
Last Updated
August 11, 2020
Results First Posted
July 11, 2019
Record last verified: 2020-08