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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Paclitaxel

• Registration Number: NCT00971945
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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)"

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2005-06-30
• Primary Completion: 2008-03-31
• Study Completion: 2008-03-31
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Results First Submitted: 2021-03-19
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Results First Posted: 2021-05-25
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events	From first dose to end of follow-up period (up to approximately 33 months)	This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)
Number of Participants Experiencing Laboratory Tests Abnormalities	From first dose to end of follow-up period (up to approximately 33 months)	This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed: * Enzyme investigations; * Hematology investigations; * Hepatobiliary investigations; * Lipid investigations; * Protein and chemistry analyses; * Renal and urinary tract investigations; * Water, electrolytes and mineral investigation. Laboratory test abnormalities were graded according to the NCI Common Toxicity Criteria version 2 (JCOG Version), resulting in a score from Grade 0 (Normal) to Grade 5 (Death due to toxicity).; Only laboratory test abnormalities with a Grade 3 or higher are reported

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	From first dose to end of follow-up period (up to approximately 33 months)	ORR is defined as the number (percentage) of participants achieving either a Complete Response (CR) or Partial Response (PR) to therapy. CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of all target lesions (taking as reference the baseline sum LD).; Target Lesions were evaluated according to "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer."
Duration of Response (DOR)	From first date of Partial Response (in study NCT01023204) to first date of Progressive Disease (in study NCT01023204 or NCT00971945) (up to approximately 37 months)	DOR is defined as the median time from the first date of Partial Response (assessed as per the "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer") to the first date of Progressive Disease. Participants were evaluated for DOR in 2 separate studies (NCT01023204 and NCT00971945). Results are representative of the cumulative DOR assessed in both studies.

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Toshima-ku, Tokyo, Japan