Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

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Detailed Description

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Conditions

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Breast Neoplasms Neoplasm Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Advanced breast cancer

Group Type EXPERIMENTAL

SKI-606 (Bosutinib)

Intervention Type DRUG

SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.

Interventions

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SKI-606 (Bosutinib)

SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage IIIB, IIIC or IV breast cancer not curable with available therapy.
* Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.
* Life expectancy of at least 16 weeks.
* Ability to swallow whole capsules.

Exclusion Criteria

* Use of or requirement for bisphosphonates within 8 weeks prior to screening.
* Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ
* Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.
* Recent or ongoing significant gastrointestinal disorder

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No