Status:
TERMINATED
Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer
Lead Sponsor:
Baylor Breast Care Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
We, the investigators at Baylor Breast Care Cancer, are doing this study to learn how well Taxotere makes tumors become smaller. We are also doing this study to find out how well Taxotere treats the t...
Detailed Description
New treatment strategies are needed to improve the clinical outcome in breast cancer patients at high risk of tumor recurrence. Even with the best present combination chemotherapy, radiotherapy and su...
Eligibility Criteria
Inclusion
- All patients must be female
- Locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible; locally advanced cancers must be of clinical and/or radiologic size \> 4 cm and/or are deemed surgically inoperable.
- Negative serum pregnancy test (beta-human chorionic gonadotropin \[b-HCG\]) within 7 days of starting study, if of childbearing potential
- Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal
- Performance status (World Health Organization \[WHO\] scale) \< 2 and life expectancy \> 6 months
- Age \> 18 years old
- No brain and/or leptomeningeal disease
- No previous or current malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
Exclusion
- Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
- Severe underlying chronic illness or disease
- Patients on other investigational drugs while on study will be excluded.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00206453
Start Date
January 1 2002
End Date
January 1 2005
Last Update
February 5 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor Breast Center
Houston, Texas, United States, 77030