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: February 10, 2014
Last verified: February 2014

October 19, 2010
February 10, 2014
June 2011
September 2014   (final data collection date for primary outcome measure)
Progression free survival rate at 24 weeks [ Time Frame: 24 weeks after initiating study treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01225172 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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®
  • Experimental: BMS-754807
    Intervention: Drug: BMS-754807
  • Experimental: BMS-754807 + letrozole
    Interventions:
    • Drug: BMS-754807
    • Drug: letrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01225172
CA191-011
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Mayo Clinic
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP