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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225172
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : March 23, 2017
Mayo Clinic
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: BMS-754807 Drug: letrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. Progression free survival rate at 24 weeks [ Time Frame: 24 weeks after initiating study treatment ]

Secondary Outcome Measures :
  1. Assess the objective response rate and duration of response in subjects with measurable disease [ Time Frame: 24 weeks ]
  2. 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) ]
  3. Treatment failure rate [ Time Frame: 24 weeks ]
  4. Anti-proliferative effects using FLT-PET ([18F]-3'-deoxy-3'-fluorothymidine positron emitting tomography) [ Time Frame: 14 days after initiating study treatment ]
  5. 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) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225172

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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01225172     History of Changes
Other Study ID Numbers: CA191-011
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: December 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists