Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel (ETCat01)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer|
- Determining pathologic complete remission under study treatment [ Time Frame: 28 days after last administration of chemotherapy ] [ Designated as safety issue: No ]
- Rate of breast conserving operations [ Time Frame: 28 days after administration of last chemotherapy ] [ Designated as safety issue: No ]
- Response to treatment [ Time Frame: 28 days after last administration of chemotherapy ] [ Designated as safety issue: No ]
- Determining the therapy associated toxicity [ Time Frame: 28 days after last administration of chemotherapy ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Drug: Epirubicin, 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.
|Krankenhaus St. Elisabeth u. St. Barbara|
|Halle, Sachsen-Anhalt, Germany, 06110|
|Magdeburg, Sachsen-Anhalt, Germany, 39110|
|Asklepios Krankenhaus Weissenfels|
|Weissenfels, Sachsen-Anhalt, Germany, 06667|
|Principal Investigator:||Dieter Lampe, Dr. med.||Asklepios Krankenhaus Weissenfels|