Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: BMS-690514; Drug: Lapatinib; Drug: Letrozole

• Registration Number: NCT01068704
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Study Start: 2010-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Disposition First Submitted: 2012-03-24
• Status Verified: 2015-09
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• Documented invasive breast cancer
• Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
• HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
• Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
• ECOG Performance status = 0 or 1

Exclusion Criteria

• Prior hormonal therapy for metastatic disease
• Prior hormonal therapy with letrozole for adjuvant disease
• Symptomatic brain metastases
• Prior treatment with any tyrosine kinase inhibitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-690514 + Letrozole	BMS-690514	-
BMS-690514 + Letrozole	Letrozole	-
Lapatinib + Letrozole	Lapatinib	-
Lapatinib + Letrozole	Letrozole	-

Primary Outcome Measures

Name	Time	Method
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months	Every 8 weeks according to CT scan

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival: defined as time to disease progression	Every 8 weeks
Frequency and severity of adverse events in all subjects	Every 4 weeks
Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'	Every 8 weeks

Trial Locations

Locations (5)

Texas Oncology-Abilene; 🇺🇸 Abilene, Texas, United States

Texas Oncology-Beaumont; 🇺🇸 Beaumont, Texas, United States

Us Oncology Central Pharmacy; 🇺🇸 Fort Worth, Texas, United States

Yakima Valley Memorial Hospital/North Star Lodge; 🇺🇸 Yakima, Washington, United States

Local Institution; 🇵🇪 Lima, Peru