Overview

Neoadjuvant Taxotere

Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
0
Participant gender:
Female
Summary
The purposes of this study are to better understand how Taxotere causes tumors to become smaller and to find out how effective Taxotere is in treating the type of breast cancer that you have.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baylor Breast Care Center
Collaborator:
Aventis Pharmaceuticals
Treatments:
Docetaxel
Criteria
Inclusion Criteria:

- 1. All patients must be female. 2. Signed informed consent. 3. Locally advanced breast
cancers or primary breast cancers with concomitant metastatic disease are eligible.
Locally advanced cancers must be of clinical and/or radiologic size >4 cm and/or are
deemed surgically inoperable. 4. Negative serum pregnancy test within 7 days of
starting study, if of child-bearing potential. 5. Adequate bone marrow function:
Hematocrit of greater than 30%, total neutrophil count must be >1.5 x 10(9)/L and
platelets of >100 x 10(9)/L prior to the start of any cycle. 6. Kidney function tests
- within 1.5 times of the institution's upper limit of normal. Total serum bilirubin
within upper limit of normal. 7. Electrocardiogram showing no acute ischemic changes.
8. Performance status (WHO scale) <2 (Appendix I) and life expectancy >1 year. 9. Age
> 18 years. 10. No brain and/or leptomeningeal disease. 11. No previous or current
malignancies at other sites within the last 5 years, with exception of adequately
treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell
carcinoma of the skin.

Exclusion Criteria:

- 1. Pregnancy or unwillingness to use reliable contraceptive method in women of
child-bearing potential. 2. Severe underlying chronic illness or disease. 3.
Peripheral neuropathy - grade 2 or greater. 4. Patients on other investigational drugs
while on study will be excluded. 5. Severe or uncontrolled hypertension, history of
congestive heart failure, or severe coronary arterial disease.