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

Study Overview
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Brief Summary
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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)

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br> | Drug: Paclitaxel<br>* Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent<br>* Other names: BMS-181339;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events | This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively) | From first dose to end of follow-up period (up to approximately 33 months) | 
| Number of Participants Experiencing Laboratory Tests Abnormalities | 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 | From first dose to end of follow-up period (up to approximately 33 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | 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. | From first dose to end of follow-up period (up to approximately 33 months) | 
| Duration of Response (DOR) | 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. | 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) |