Biologic Correlative Taxotere/AC (TAX/AC)
We are asking you to take part in a research study of biomarkers (characteristics or traits of the genes inside cancer cells). We want to learn if these biomarkers could help us learn how well your breast cancer may respond (improve) to chemotherapy (drugs to treat cancer).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Multicenter Trial of Neoadjuvant Taxotere and Adriamycin/Cytoxan(AC): A Biologic Correlative Study|
- The primary objective this extension study is to obtain enough additional cases evaluable for microarray analyses to complete our studies to identify profiles of a small number of genes that are predictive of response. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- To determine pathologic complete response and to correlate this to a prospectively determined Taxotere gene expression profile;time to tumor progression;overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2002|
|Study Completion Date:||January 2012|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Active Comparator: One
Docetaxel (Taxotere) 100 mg/m2 is to be administered on day 1. A core biopsy is to be performed one day after chemotherapy (day 2) and on days 8, 15 and 22. On day 22, after repeat core biopsy, a second cycle of docetaxel (Taxotere) chemotherapy (100 mg/m2) will be given. Docetaxel (Taxotere) will be given three-weekly for a total of four cycles. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.
Other Name: Docetaxel (Taxotere)Drug: Adriamycin/cytoxan
Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.
Other Name: doxorubicin 60 mg/m2 and cyclosphosphamide 600 mg/m2
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206466
|United States, Texas|
|Baylor Breast Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mothaffar C Rimawi, MD||Baylor Breast Center|