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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01225172
First received: October 19, 2010
Last updated: July 23, 2014
Last verified: February 2014
  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:


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: December 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
Univ Of Al At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
Illinois Cancercare, Pc
Peoria, Illinois, United States, 61615
United States, Indiana
Indiana University Health Goshen Center For Cancer Care
Goshen, Indiana, United States, 46526
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
Oncology Care Associates, P.A.
Wheaton, Maryland, United States, 20902
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, Texas
Ut Md Anderson Can Ctr.
Houston, Texas, United States, 77030
United States, Virginia
University Of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Bristol-Myers Squibb
Mayo Clinic
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Letrozole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014