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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00044525 |
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 BAY 59-8862 will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Neoplasms Metastases, Neoplasm |
Drug: Bay 59-8862 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY 59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Medical Oncology/Hematology | |
Meriden, Connecticut, United States, 06450 | |
United States, Florida | |
University of Florida - Jacksonville | |
Jacksonville, Florida, United States, 32209 | |
United States, Kentucky | |
Norton Healthcare Pavillion | |
Louisville, Kentucky, United States, 40202 | |
United States, Ohio | |
Mid-Ohio Oncology/Hematology | |
Columbus, Ohio, United States, 43213 | |
Hematology Oncology Consultants | |
Columbus, Ohio, United States, 43235 | |
United States, Pennsylvania | |
Pennsylvania Onc./Hem. Assoc. | |
Philadelphia, Pennsylvania, United States, 19106 |
Study ID Numbers: | Protocol No. 10654 |
Study First Received: | August 30, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00044525 |
Health Authority: | United States: Food and Drug Administration |
Taxane Breast Cancer Metastasis |
Skin Diseases Neoplasm Metastasis Breast Neoplasms Taxane Breast Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |