Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer
Phase 2
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA139-371
NCT ID:
NCT01023204
Start Date:
October 2002
Completion Date:
July 2005
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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