check_circleStudy Completed

Breast Neoplasms, Breast Cancer, Metastatic

Bayer Identifier:

10654

ClinicalTrials.gov Identifier:

NCT00044525

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 Years

  • - 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

  • - 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.

Trial summary

Enrollment Goal
82
Trial Dates
April 2002 - February 2004
Phase
Phase 2
Could I Receive a placebo
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Heraklion, 711 10, Greece
Completed
Jena, 07740, Germany
Completed
Stuttgart, 70376, Germany
Completed
London, SW3 6JJ, United Kingdom
Completed
Berlin, 10117, Germany
Completed
Haifa, 3109601, Israel
Completed
Biella, 13900, Italy
Completed
Parma, 43126, Italy
Completed
Aarau, 5001, Switzerland
Completed
London, NW3 2QG, United Kingdom
Completed
Ashkelon, 7830604, Israel
Completed
Forlì, 47100, Italy
Completed
Warszawa, 04-141, Poland
Completed
Maroussi, 15123, Greece
Completed
Milano, 20089, Italy
Completed
Olsztyn, 10-228, Poland
Completed
Ramat Gan, 52482, Israel
Completed
Bergamo, 24047, Italy
Completed
Tel Aviv, 64239, Israel
Completed
Warszawa, 02-781, Poland
Completed
Berlin, 13125, Germany
Completed
Cuneo, 12100, Italy
Completed
Udine, 33100, Italy
Withdrawn
München, 80637, Germany
Withdrawn
Plantation, 33324, United States
Withdrawn
United Kingdom
Withdrawn
Rehovot, 7610001, Israel
Withdrawn
Jacksonville, 32209, United States
Withdrawn
Cardiff, CF14 2TL, United Kingdom
Withdrawn
Poland
Withdrawn
Philadelphia, 19106, United States
Withdrawn
München, 80336, Germany
Withdrawn
Perugia, 06122, Italy
Withdrawn
Louisville, 40202, United States
Withdrawn
Sutton, SM2 5PT, United Kingdom
Withdrawn
Columbus, 43213, United States
Withdrawn
Waterbury, 06708-2904, United States
Withdrawn
Columbus, 43235, United States

Trial design

An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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