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

Klinikum Weissenfels50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Breast Cancer

Interventions

Epirubicin, Carboplatin, DocetaxelDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Krankenhaus St. Elisabeth u. St. Barbara

Halle, Saxony-Anhalt, Germany

Klinikum Marienstift

Magdeburg, Saxony-Anhalt, Germany

Asklepios Krankenhaus Weissenfels

Weißenfels, Saxony-Anhalt, Germany

Outcomes

Primary Outcomes

Determining pathologic complete remission under study treatment

Time frame: 28 days after last administration of chemotherapy

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.