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

NCT ID: NCT01023204

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-07-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent

Interventions

Paclitaxel

Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent

Intervention Type: DRUG

Other Intervention Names

Taxol; BMS-181339

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA139-371

Identifier Type: -

Identifier Source: org_study_id