Primary Breast Cancer Clinical Trial
Official title:
Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer
The purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer. Therefore patients become first 3 cycles of Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.
Most of the women who are diagnosed with breast cancer are in the situation that an
operation is possible. Using a neoadjuvant therapy the rate of breast-conserving surgery can
be extended and tumor cell proliferation may be inhibited. Further the neoadjuvant
chemotherapy is an in-vivo-activity-test for the used drugs. Epirubicin, Docetaxel and
Carboplatin have shown antineoplastic activity against solid cancer alone and in
combination.
Using two different combinations of these three drugs, first 3 cycles Epirubicin/Docetaxel
and then changing to Carboplatin/Docetaxel for 3 further cycles it is assumed that the
results of the therapy will improve. Main criterion is the determination of pCR, second
criteria are the rate of breast-conserving surgery, tumor response and therapy-dependent
toxicities.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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