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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01023204

CA139-371

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: Female

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Paclitaxel

Experimental group

Treatment:

Drug: Paclitaxel