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

Bristol-Myers Squibb0 sites68 target enrollmentOctober 2002

ConditionsBreast Cancer

InterventionsPaclitaxel

DrugsPaclitaxel

Overview

Phase: Phase 2
Intervention: Paclitaxel
Conditions: Breast Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 68
Primary Endpoint: 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
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

July 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bristol-Myers Squibb

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

Arms & Interventions

Paclitaxel

Intervention: Paclitaxel

Outcomes

Primary Outcomes

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

Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity

Safety: incidence and severity of adverse events, laboratory test abnormalities

Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity

Secondary Outcomes

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)