Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-05-31

Brief Summary

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This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ 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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Dasatinib

Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

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

Dasatinib 100 mg

Intervention Type DRUG

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

Interventions

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Dasatinib

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

Intervention Type DRUG

Dasatinib 100 mg

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

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825 Sprycel BMS-354825

Eligibility Criteria

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Inclusion Criteria

* females, 18 or older
* recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
* paraffin-embedded tissue block must be available
* measurable disease
* prior chemotherapy with an anthracycline and/or a taxane (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 central nervous system (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