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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-12-31

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

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-690514 + Letrozole

Group Type ACTIVE_COMPARATOR

BMS-690514

Intervention Type DRUG

Tablets, Oral, 200 mg, once daily, \~ 12 months depending on response

Letrozole

Intervention Type DRUG

Tablets, Oral, 2.5 mg, once daily, \~ 12 months depending on response

Lapatinib + Letrozole

Group Type ACTIVE_COMPARATOR

Lapatinib

Intervention Type DRUG

Tablets, Oral, 1500 mg, once daily, \~ 12 months depending on response

Letrozole

Intervention Type DRUG

Tablets, Oral, 2.5 mg, once daily, \~ 12 months depending on response

Interventions

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BMS-690514

Tablets, Oral, 200 mg, once daily, \~ 12 months depending on response

Intervention Type DRUG

Lapatinib

Tablets, Oral, 1500 mg, once daily, \~ 12 months depending on response

Intervention Type DRUG

Letrozole

Tablets, Oral, 2.5 mg, once daily, \~ 12 months depending on response

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No