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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: BMS-754807 Drug: letrozole	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Progression free survival rate at 24 weeks [ Time Frame: 24 weeks after initiating study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the objective response rate and duration of response in subjects with measurable disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Safety through adverse event reporting and laboratory abnormalities [ Time Frame: 24 weeks and ongoing during the study until discontinuation of study medication (through last patient last visit) ] [ Designated as safety issue: Yes ]
Treatment failure rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Anti-proliferative effects using FLT-PET ([18F]-3'-deoxy-3'-fluorothymidine positron emitting tomography) [ Time Frame: 14 days after initiating study treatment ] [ Designated as safety issue: No ]
Describe changes in various biomarkers related to breast cancer [ Time Frame: Ongoing during the study until discontinuation of study medication (about every 30 days until last patient last visit) ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BMS-754807	Drug: BMS-754807 Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity
Experimental: BMS-754807 + letrozole	Drug: BMS-754807 Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity Drug: letrozole Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity Other Name: Femara®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225172

Locations

United States, Alabama
Univ Of Al At Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Donald W. Hill M.D., P.C.
Casa Grande, Arizona, United States, 85122
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Georgia
Georgia Cancer Specialists I, Pc
Atlanta, Georgia, United States, 30341
United States, Illinois
Illinois Cancercare, Pc
Peoria, Illinois, United States, 61615
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Ctr At Johns Hopkins
Baltimore, Maryland, United States, 21231
Northwest Hospital Center
Randallstown, Maryland, United States, 21133
United States, Minnesota
Masonic Cancer Ctr, University Of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
Unv. Of Nc At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Presbyterian Hospital Cancer Research
Charlotte, North Carolina, United States, 28204
Duke University Medical Center-Dept Of Medicine
Durham, North Carolina, United States, 27710
United States, Rhode Island
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, Texas
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Bristol-Myers Squibb

Mayo Clinic

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01225172 History of Changes
Other Study ID Numbers:	CA191-011
Study First Received:	October 19, 2010
Last Updated:	March 28, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole

Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013