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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00288249

Enrollment

Registered

2006-02-07

Start date

2005-12-31

Completion date

2009-01-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Metastatic, Breast Neoplasms

Keywords

Breast Cancer, Breast Neoplasms

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.

Interventions

DRUGSagopilone (BAY86-5302, ZK 219477)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Austria, Belgium, Bulgaria, France, Germany, Italy, Poland, Slovenia, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026