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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00044525 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Breast Cancer, Metastatic |
Drug: BAY59-8862 (Cytotoxic Taxane) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Enrollment: | 84 |
| Study Start Date: | April 2002 |
| Study Completion Date: | February 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: BAY59-8862 (Cytotoxic Taxane)
1 h intravenous infusion every 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Stuttgart, Baden-Württemberg, Germany, 70376 | |
| Jena, Thüringen, Germany, 07740 | |
| Berlin, Germany, 10117 | |
| Greece | |
| Maroussi, Attica, Greece, 15123 | |
| Heraklion, Creta, Greece, 711 10 | |
| Israel | |
| Ashkelon, Israel, 78306 | |
| Haifa, Israel, 31096 | |
| Tel Aviv, Israel, 64239 | |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| Treviglio, Bergamo, Italy, 24047 | |
| Rozzano, Milano, Italy, 20089 | |
| Biella, Italy, 13900 | |
| Cuneo, Italy, 12100 | |
| Forlì, Italy, 47100 | |
| Parma, Italy, 43100 | |
| Udine, Italy, 33100 | |
| Poland | |
| Olsztyn, Poland, 10-228 | |
| Warszawa, Poland, 02-781 | |
| Warszawa, Poland, 00-909 | |
| Switzerland | |
| Aarau, Aargau, Switzerland, 5001 | |
| United Kingdom | |
| London, Greater London, United Kingdom, SW3 6JJ | |
| London, Greater London, United Kingdom, NW3 2QG | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00044525 History of Changes |
| Other Study ID Numbers: | 10654 |
| Study First Received: | August 30, 2002 |
| Last Updated: | April 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Taxane Breast Cancer Metastasis |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
Taxane Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |