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Home > "E" Clinical Trials Conditions > Evaluation of Differing Taxanes/Taxane Combinations on the Outcomes of Patients with Operable Breast Cancer  Evaluation of Differing Taxanes/Taxane Combinations on the Outcomes of Patients with Operable Breast Cancer
Evaluation of Differing Taxanes/Taxane Combinations on the Outcomes of Patients with Operable Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , Hoffmann-La Roche,Pharmacia
Synopsis: The purpose of this study is to evaluate two taxane regimens (weekly paclitaxel or docetaxel + capecitabine) given in addition to anthracycline based therapy in patients with newly diagnosed breast cancer as adjuvant or neoadjuvant therapy. The objectives of the study are: 1) to evaluate the ability of these two treatments to prevent recurrence and impact survival, 2) to evaluate the ability of the taxane regimens to reduce the tumor size and 3) increase the possibility of breast conservative surgery when given in the neoadjuvant setting.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Histologic confirmation of invasive, but non-inflammatory carcinoma of the breast, stages I-IIIA. Stage I breast cancer patients with high risk (any of the following: Ki67 >35%, ER/PR negative, Her-2/neu positive, poorly differentiated tumor, or lymphovascular invasion) are eligible for adjuvant therapy only. - Patients to be treated in the neoadjuvant setting must have measurable disease. - Patients with bilateral breast cancers are eligible. - May have a prior history of breast cancer if current breast cancer is of higher stage and patient has not received any of the study medications including doxorubicin. - Signed informed consent - Adequate bone marrow function: granulocytes >1500/mm3 and platelets >100,000/mm3. Adequate liver and renal function: normal bilirubin and creatinine <2.5 mg% - Patients with uncompensated congestive heart failure or patients with myocardial infarction within 12 months are not eligible.
Total Enrollment: 930
Location and Contact Information:
The University of Texas M. D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Cynthia Carter 713-792-2817
Additional Information:
Study ID Numbers: ID01-580; Operable Breast Cancer,Taxanes
Study Start Date: November 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050167
Other Breast Cancer Studies:
1. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
2. Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
3. Capecitabine Combined with Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
5. Sister Study
Related Studies:
Other Breast Cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Evaluation of Differing Taxanes/Taxane Combinations on the Outcomes of Patients with Operable Breast Cancer
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