Trial Condition(s):

Breast Neoplasms, Breast Cancer, Metastatic

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

Bayer Identifier:

10654

ClinicalTrials.gov Identifier:

NCT00044525

EudraCT Number:

Not Available

Study Completed

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.

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.

Trial Summary

Enrollment Goal
82
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Heraklion, Greece, 711 10

Status
Completed
 
Locations

Investigative Site

Jena, Germany, 07740

Status
Completed
 
Locations

Investigative Site

Stuttgart, Germany, 70376

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SW3 6JJ

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 10117

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Biella, Italy, 13900

Status
Completed
 
Locations

Investigative Site

Parma, Italy, 43126

Status
Completed
 
Locations

Investigative Site

Aarau, Switzerland, 5001

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Investigative Site

Ashkelon, Israel, 7830604

Status
Completed
 
Locations

Investigative Site

Forlì, Italy, 47100

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 04-141

Status
Completed
 
Locations

Investigative Site

Maroussi, Greece, 15123

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20089

Status
Completed
 
Locations

Investigative Site

Olsztyn, Poland, 10-228

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 52482

Status
Completed
 
Locations

Investigative Site

Bergamo, Italy, 24047

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-781

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 13125

Status
Completed
 
Locations

Investigative Site

Cuneo, Italy, 12100

Status
Completed
 
Locations

Investigative Site

Udine, Italy, 33100

Status
Completed
 

For details, please refer to trial results

Additional Information