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

This study has been completed.

Sponsor:

Information provided by:

Klinikum Weissenfels

ClinicalTrials.gov Identifier:

NCT00527449

First received: September 7, 2007

Last updated: January 14, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2007

Last Updated Date

January 14, 2010

Start Date ^ICMJE

May 2006

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determining pathologic complete remission under study treatment [ Time Frame: 28 days after last administration of chemotherapy ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Determining pathologic complete remission under study treatment

Change History

Complete list of historical versions of study NCT00527449 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of breast conserving operations [ Time Frame: 28 days after administration of last chemotherapy ] [ Designated as safety issue: No ]
Response to treatment [ Time Frame: 28 days after last administration of chemotherapy ] [ Designated as safety issue: No ]
Determining the therapy associated toxicity [ Time Frame: 28 days after last administration of chemotherapy ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Rate of breast conserving operations
Response to treatment
Determinig the therapy associated toxicity

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Breast Cancer

Intervention ^ICMJE

Drug: 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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00527449

Other Study ID Numbers ^ICMJE

3305000

Has Data Monitoring Committee

Responsible Party

Dieter Lampe, Dr. med., Klinikum Weissenfels

Study Sponsor ^ICMJE

Klinikum Weissenfels

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dieter Lampe, Dr. med.

Asklepios Krankenhaus Weissenfels

Information Provided By

Klinikum Weissenfels

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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