Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00050167|
Recruitment Status : Completed
First Posted : November 27, 2002
Results First Posted : August 5, 2011
Last Update Posted : August 29, 2011
- Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer.
- Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel.
- Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Paclitaxel Drug: Docetaxel Drug: Capecitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||603 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||August 2011|
Experimental: Weekly Paclitaxel (WP)
Weekly Paclitaxel (WP) for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
80 mg/m^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks
Other Name: Taxol
Experimental: Docetaxel and Capecitabine (DX)
Docetaxel + Capecitabine (DX) days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
75 mg/m^2 by vein (IV) Over 1 Hour Once Every 3 Weeks
Other Name: Taxotere
1500 mg/m^2 by mouth Twice Daily x 2 Weeks
Other Name: Xeloda
- Percentage of Participants With Reoccurrence [ Time Frame: Median of 50 months ]Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).
- Proportion of Participants With Pathological Complete Response [ Time Frame: 7 Years ]Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.
- Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes [ Time Frame: 7 years ]Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050167
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aman U. Buzdar, MD||M.D. Anderson Cancer Center|