Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Paclitaxel

• Registration Number: NCT01023204
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent breast cancer

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Status Verified: 2009-12
• Study First Posted: 2009-12-02
• Disposition First Submitted: 2010-02-02
• Disposition First Submitted QC: 2010-02-02
• Last Update Submitted: 2010-02-02
• Disposition First Posted: 2010-02-04
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Patients with primary advanced inoperable disease who were refractory to chemotherapy
• Patients with recurrent disease following post-operative adjuvant chemotherapy
• Patients who were not amenable to post-recurrence chemotherapy

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Exclusion Criteria

• Patients with serious, uncontrolled medical illness
• Patients with previous therapy with taxanes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria	Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities	Each 49 day course of treatment until withdrawal or unacceptable toxicity

Secondary Outcome Measures

Name	Time	Method
Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer	Each 49 day course of treatment until withdrawal or unacceptable toxicity