NCT00527449

Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel

Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Klinikum Weissenfels · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-09-10
• Last updated: 2010-01-15

Locations

3 sites across 1 country: Germany