Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients

Breast cancer is the most common form of cancer among women in developing countries, accounting for approximately one-fifth of all female cancers in the United States. Although mortality rates are declining in some countries, it remains the leading cause of death in women aged 40-55 years. The median survival for women with metastatic breast cancer is 2-3 years but there is significant variability in this population. The primary goals of treatment in patients with metastatic breast cancer are improvement or maintenance of quality of life and prolongation of survival. The taxanes, paclitaxel and docetaxel, were incorporated into the treatment of metastatic breast cancer in the 1990's. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in taxane-resistant metastatic breast cancer.

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Key information

Conditions

Breast Neoplasms Breast Cancer, Metastatic Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Stuttgart, Baden-Wurttemberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patients with a proven diagnosis of metastatic breast cancer
Measurable disease as defined by the presence of at least one measurable lesion
Patients must have received at least 3 weeks of continuous therapy with Taxane
patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
Patients who failed on hormone therapy
Life expectancy of at least 12 weeks.
Adequate bone marrow, liver and kidney function
Patients with active brain metastases may be included

Exclusion criteria

Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia; surgery within 4 weeks of study entry; serious infections; HIV infection; chronic hepatitis B or C; patients with brain metastases must be without a seizure; hypersensitivity to taxanes; organ transplants; some previous cancers
Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
Others: pregnant or breast-feeding patients; women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.

Treatment and study plan

BAY59-8862 (Cytotoxic Taxane)

Drug

1 h intravenous infusion every 3 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Sep 4, 2002
Registry last updated: Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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