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

Bayer82 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasms Breast Cancer, Metastatic

Interventions

Sagopilone (BAY86-5302, ZK 219477)DRUG

16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Sagopilone (BAY86-5302, ZK 219477)DRUG

12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Sagopilone (BAY86-5302, ZK 219477)DRUG

22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Unnamed facility

Vienna, State of Vienna, Austria

Unnamed facility

Vienna, State of Vienna, Austria

Unnamed facility

Brasschaat, Belgium

Outcomes

Primary Outcomes

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).

Time frame: Every 6 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: Every 6 weeks

Data from ClinicalTrials.gov

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