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

Phase 2

Completed

• Conditions: Breast Neoplasms; Breast Cancer, Metastatic
• Interventions: Drug: Sagopilone (BAY86-5302, ZK 219477)

• Registration Number: NCT00288249
• Lead Sponsor: Bayer

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2008-03
• Study Completion: 2009-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Sagopilone (BAY86-5302, ZK 219477)	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)
Arm 1	Sagopilone (BAY86-5302, ZK 219477)	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)
Arm 4	Sagopilone (BAY86-5302, ZK 219477)	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)
Arm 2	Sagopilone (BAY86-5302, ZK 219477)	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)

Primary Outcome Measures

Name	Time	Method
Tumor response rate (complete or partial response according to RECIST)	Every 6 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Duration of complete or partial tumor response	Every 6 weeks	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
Time to tumor progression	Every 6 weeks	Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer