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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Lapatinib; Drug: Letrozole; Drug: BMS-690514

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068704

2009-016622-13 (EudraCT Number)

CA187-016

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

BMS-690514 + Letrozole

Active Comparator group

Treatment:

Drug: Letrozole

Drug: BMS-690514

Lapatinib + Letrozole

Active Comparator group

Treatment:

Drug: Letrozole

Drug: Lapatinib