Clinical trial NCT01225172: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2010-10-20
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression Free Survival Rate at 24 Weeks
timeFrame: 24 weeks after initiation of study treatment
Secondary outcomes:
measure: The Objective Response Rate (ORR) in Participants With Measurable Disease
timeFrame: 24 weeks after initiation of study treatment
measure: Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths
timeFrame: Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months
measure: Duration of Response (DOR) in Participants With Measurable Disease
timeFrame: 24 weeks after initiation of study treatment
measure: Number of On-study Laboratory Abnormalities: Grade 1-2
timeFrame: Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)
measure: Number of On-study Laboratory Abnormalities: Grade 3-4
timeFrame: Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)
measure: Treatment Failure Rate (TFR)
timeFrame: 24 weeks after initiation of study treatment
measure: Changes in Absolute Copy Numbers and Relative Expression of Insulin Receptor Isoform A (IR-A) in Tumor Tissue in Response to Treatment
timeFrame: 24 weeks after initiation of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ Of Al At Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancercare, Pc
state: Illinois
city: Goshen
country: United States
facility: Indiana University Health Goshen Center For Cancer Care
state: Indiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: Wheaton
country: United States
facility: Oncology Care Associates, P.A.
state: Maryland
city: Minneapolis
country: United States
facility: Masonic Cancer Ctr, University Of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: Unv. Of Nc At Chapel Hill
state: North Carolina
city: Chapel Hill
country: United States
facility: Unv. Of Nc At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital Cancer Research
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center-Dept Of Medicine
state: North Carolina
city: Houston
country: United States
facility: Ut Md Anderson Can Ctr.
state: Texas
city: Houston
country: United States
facility: Ut Md Anderson Can Ctr.
state: Texas
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: