A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-09-30

Brief Summary

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This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.

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Detailed Description

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Conditions

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Breast Cancer Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg \<6 months)

2

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg \<6 months)

Interventions

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Dasatinib

Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg \<6 months)

Intervention Type DRUG

Dasatinib

Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg \<6 months)

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825

Eligibility Criteria

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Inclusion Criteria

* females, 18 or older
* recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer
* paraffin-embedded tissue block must be available
* measurable disease
* prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)
* 0, 1 or 2 chemotherapies in the metastatic setting
* adequate organ function

Exclusion Criteria

* Metastatic disease confined to bone only
* Symptomatic CNS metastasis
* Concurrent medical condition which may increase the risk of toxicity
* Unable to take oral medication

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No