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

Study Overview
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Brief Summary
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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

Official Title
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An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: BMS-690514
* Drug: Lapatinib
* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-690514 + Letrozole<br> | Drug: BMS-690514<br>* Tablets, Oral, 200 mg, once daily,   12 months depending on response<br>Drug: Letrozole<br>* Tablets, Oral, 2.5 mg, once daily,   12 months depending on response<br>|
| Active Comparator: Lapatinib + Letrozole<br> | Drug: Lapatinib<br>* Tablets, Oral, 1500 mg, once daily,   12 months depending on response<br>Drug: Letrozole<br>* Tablets, Oral, 2.5 mg, once daily,   12 months depending on response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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