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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044525
Recruitment Status : Completed
First Posted : September 4, 2002
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer, Metastatic Drug: BAY59-8862 (Cytotoxic Taxane) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer
Study Start Date : April 2002
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY59-8862 (Cytotoxic Taxane)
1 h intravenous infusion every 3 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044525

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Stuttgart, Baden-Württemberg, Germany, 70376
Jena, Thüringen, Germany, 07740
Berlin, Germany, 10117
Maroussi, Attica, Greece, 15123
Heraklion, Creta, Greece, 711 10
Ashkelon, Israel, 78306
Haifa, Israel, 31096
Tel Aviv, Israel, 64239
Tel Hashomer, Israel, 52621
Treviglio, Bergamo, Italy, 24047
Rozzano, Milano, Italy, 20089
Biella, Italy, 13900
Cuneo, Italy, 12100
Forlì, Italy, 47100
Parma, Italy, 43100
Udine, Italy, 33100
Olsztyn, Poland, 10-228
Warszawa, Poland, 00-909
Warszawa, Poland, 02-781
Aarau, Aargau, Switzerland, 5001
United Kingdom
London, Greater London, United Kingdom, NW3 2QG
London, Greater London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer Identifier: NCT00044525    
Other Study ID Numbers: 10654
First Posted: September 4, 2002    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
IDN 5109
Antineoplastic Agents