Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel (ETCat01)

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Breast Cancer
• Intervention / Treatment: Drug: Epirubicin, 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06110
      • Krankenhaus St. Elisabeth u. St. Barbara
    • Magdeburg, Sachsen-Anhalt, Germany, 39110
      • Klinikum Marienstift
    • Weissenfels, Sachsen-Anhalt, Germany, 06667
      • Asklepios Krankenhaus Weissenfels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Klinikum Weissenfels
• Investigators: Principal Investigator: Dieter Lampe, Dr. med., Asklepios Krankenhaus Weissenfels

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 7, 2007
• First Submitted That Met QC Criteria: September 7, 2007
• First Posted (Estimate): September 10, 2007

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Carboplatin; Epirubicin
• Other Study ID Numbers: 3305000