Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: September 3, 2009
Last updated: September 10, 2010
Last verified: November 2009
The purpose of this study is to evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)"

Condition Intervention Phase
Breast Cancer
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse event [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: Every 7 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Every 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel Drug: Paclitaxel
Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Other Names:
  • Taxol
  • BMS-181339


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00971945

Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00971945     History of Changes
Other Study ID Numbers: CA139-387 
Study First Received: September 3, 2009
Last Updated: September 10, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on May 01, 2016