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

NCT ID: NCT00527449

Last Updated: 2010-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-09-30

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.

Conditions

Primary Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Klinikum Weissenfels

OTHER

Sponsor Role: lead

Responsible Party

Klinikum Weissenfels

Principal Investigators

Dieter Lampe, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Asklepios Krankenhaus Weissenfels

Locations

Krankenhaus St. Elisabeth u. St. Barbara

Halle, Saxony-Anhalt, Germany

Klinikum Marienstift

Magdeburg, Saxony-Anhalt, Germany

Asklepios Krankenhaus Weissenfels

Weißenfels, Saxony-Anhalt, Germany

Countries

Germany

Other Identifiers

3305000

Identifier Type: -

Identifier Source: org_study_id