Primary Breast Cancer
Conditions
Brief 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.
Interventions
DRUGEpirubicin, 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.
Sponsors
Klinikum Weissenfels
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining pathologic complete remission under study treatment | 28 days after last administration of chemotherapy |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed