Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

Detailed Description
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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
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Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer

Conditions
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Breast Neoplasms, Breast Cancer, Metastatic

Intervention / Treatment
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* Drug: Sagopilone (BAY86-5302, ZK 219477)
* Drug: Sagopilone (BAY86-5302, ZK 219477)
* Drug: Sagopilone (BAY86-5302, ZK 219477)
* Drug: Sagopilone (BAY86-5302, ZK 219477)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic breast cancer No previous treatment with taxanes, and vinca alkaloids Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: More than 2 previous chemotherapies Previous participation in another trial within the last 4 weeks Breast feeding Active infections

Ages Eligible for Study
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Minimum Age: 18 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 2<br>Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) | Drug: Sagopilone (BAY86-5302, ZK 219477)<br>* 12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.<br>|
| Experimental: Arm 3<br>Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) | Drug: Sagopilone (BAY86-5302, ZK 219477)<br>* 22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.<br>|
| Experimental: Arm 4<br>Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) | Drug: Sagopilone (BAY86-5302, ZK 219477)<br>* 22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.<br>|
| Experimental: Arm 1<br>Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) | Drug: Sagopilone (BAY86-5302, ZK 219477)<br>* 16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate (complete or partial response according to RECIST) | The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7). | Every 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of complete or partial tumor response | Defined as the time between the first date that confirmed complete or partial response was established as overall response and the first date that recurrence or overall response of progressive disease was documented | Every 6 weeks | 
| Time to tumor progression | Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer | Every 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Breast Neoplasms