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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin, Carboplatin, Docetaxel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determining pathologic complete remission under study treatment | 28 days after last administration of chemotherapy |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Lampe, Dr. med. | Asklepios Krankenhaus Weissenfels | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus St. Elisabeth u. St. Barbara | Halle | Saxony-Anhalt | 06110 | Germany | ||
| Klinikum Marienstift |
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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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| Determining the therapy associated toxicity |
| 28 days after last administration of chemotherapy |
| Magdeburg |
| Saxony-Anhalt |
| 39110 |
| Germany |
| Asklepios Krankenhaus Weissenfels | Weißenfels | Saxony-Anhalt | 06667 | Germany |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |