Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel (ETCat01)
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|ClinicalTrials.gov Identifier: NCT00527449|
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : January 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Primary Breast Cancer||Drug: Epirubicin, Carboplatin, Docetaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
- Drug: Epirubicin, Carboplatin, Docetaxel
75 mg/m² Docetaxel (60 minutes i.v.) and 90 mg/m² Epirubicin (10-15 min i.v.) on day 1, 22, 42. After these 3 cycles 75 mg/m² Docetaxel (60 minutes i.v.) and Carboplatin AUC 5 (30 min i. v.) on day 63, 84, 105.
- Determining pathologic complete remission under study treatment [ Time Frame: 28 days after last administration of chemotherapy ]
- Rate of breast conserving operations [ Time Frame: 28 days after administration of last chemotherapy ]
- Response to treatment [ Time Frame: 28 days after last administration of chemotherapy ]
- Determining the therapy associated toxicity [ Time Frame: 28 days after last administration of chemotherapy ]
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): NCT00527449
|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|