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

NCT ID: NCT01225172

Last Updated: 2020-08-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BMS-754807

Group Type EXPERIMENTAL

BMS-754807

Intervention Type DRUG

Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity

BMS-754807 + letrozole

Group Type EXPERIMENTAL

BMS-754807

Intervention Type DRUG

Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity

letrozole

Intervention Type DRUG

Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-754807

Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity

Intervention Type DRUG

letrozole

Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Femara®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer
* Disease progression following non-steroidal aromatase inhibitor treatment

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Univ Of Al At Birmingham

Birmingham, Alabama, United States

Site Status

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

Sharp Clinical Oncology Research

San Diego, California, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

University Of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Illinois Cancercare, Pc

Peoria, Illinois, United States

Site Status

Indiana University Health Goshen Center For Cancer Care

Goshen, Indiana, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Site Status

Oncology Care Associates, P.A.

Wheaton, Maryland, United States

Site Status

Masonic Cancer Ctr, University Of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Unv. Of Nc At Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Unv. Of Nc At Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Presbyterian Hospital Cancer Research

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center-Dept Of Medicine

Durham, North Carolina, United States

Site Status

Ut Md Anderson Can Ctr.

Houston, Texas, United States

Site Status

Ut Md Anderson Can Ctr.

Houston, Texas, United States

Site Status

University Of Virginia Health System

Charlottesville, Virginia, United States

Site Status

University Of Wisconsin

Madison, Wisconsin, United States

Site Status

University Of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA191-011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.