Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

Bayer

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasm

Treatments

Drug: Sagopilone (ZK 219477)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00313248

307975 (Other Identifier)

91466

Details and patient eligibility

About

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

Full description

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.

Enrollment

65 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Metastatic breast cancer (meaning the cancer has spread beyond its original location)
At least one measurable lesion by CT or MRI
Progression of disease following previous therapy for breast cancer
Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
Not be pregnant
Additional criteria to be determined at screening visit.

Exclusion criteria

More than 3 previous chemotherapy regimens
More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
Prior treatment with epothilones (e.g. Ixabepilone)
Symptomatic brain metastases
Additional criteria to be determined at screening visit