Neoadjuvant Taxotere

NCT00206505 | Completed Phase 2

• 1 other identifier: H 8448
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast; Cancer; Neoadjuvant; Taxotere

Outcome Measures

Primary Outcomes (1)

• efficacy of neoadjuvantTaxotere in patients with locally advanced breast cancer. Histological complete response rate

Secondary Outcomes (1)

• biologic effects of docetaxel (Taxotere) by sequential core biopsies taken before and after chemotherapy

Interventions

Taxotere DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

Baylor Breast Center

Houston, Texas, 77030, United States

Location

Related Links

• Web Site

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jenny Chang, MD

  Baylor Breast Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 1999
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

US (1)