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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Breast Cancer

Intervention / Treatment
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* Drug: Epirubicin, Carboplatin, Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically assured breast cancer age >= 18 years bone marrow function: neutrophils >= 1.5x109/l, platelets >= 100x109/l, hemoglobin >=6.2 mmol/l sufficient renal and liver function ECOG 0-2 written informed consent Exclusion Criteria: pregnant or nursing women distant metastases T2-Tumour < 3cm and G1 existing motoric or sensoric neurotoxicity > Grade 2 known hypersensitivity against Epirubicin or other anthracycline or against Carboplatin or other platin derivatives or against Docetaxel or against substances in the preparing solutions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining pathologic complete remission under study treatment |  | 28 days after last administration of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of breast conserving operations |  | 28 days after administration of last chemotherapy | 
| Response to treatment |  | 28 days after last administration of chemotherapy | 
| Determining the therapy associated toxicity |  | 28 days after last administration of chemotherapy |