Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer
1 other identifier
interventional
82
7 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2002
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 30, 2002
CompletedFirst Posted
Study publicly available on registry
September 4, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedDecember 23, 2014
December 1, 2014
1.8 years
August 30, 2002
December 18, 2014
Conditions
Keywords
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (22)
Unknown Facility
Stuttgart, Baden-Wurttemberg, 70376, Germany
Unknown Facility
Berlin, State of Berlin, 10117, Germany
Unknown Facility
Jena, Thuringia, 07740, Germany
Unknown Facility
Marousi, Attica, 15123, Greece
Unknown Facility
Heraklion, Crete, 711 10, Greece
Unknown Facility
Ashkelon, 78306, Israel
Unknown Facility
Haifa, 31096, Israel
Unknown Facility
Tel Aviv, 64239, Israel
Unknown Facility
Tel Litwinsky, 52621, Israel
Unknown Facility
Treviglio, Bergamo, 24047, Italy
Unknown Facility
Rozzano, Milano, 20089, Italy
Unknown Facility
Biella, 13900, Italy
Unknown Facility
Cuneo, 12100, Italy
Unknown Facility
Forlì, 47100, Italy
Unknown Facility
Parma, 43100, Italy
Unknown Facility
Udine, 33100, Italy
Unknown Facility
Olsztyn, 10-228, Poland
Unknown Facility
Warsaw, 00-909, Poland
Unknown Facility
Warsaw, 02-781, Poland
Unknown Facility
Aarau, Canton of Aargau, 5001, Switzerland
Unknown Facility
London, Greater London, NW3 2QG, United Kingdom
Unknown Facility
London, Greater London, SW3 6JJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2002
First Posted
September 4, 2002
Study Start
April 1, 2002
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
December 23, 2014
Record last verified: 2014-12