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

September 7, 2007
January 14, 2010
May 2006
September 2008   (final data collection date for primary outcome measure)
Determining pathologic complete remission under study treatment [ Time Frame: 28 days after last administration of chemotherapy ] [ Designated as safety issue: No ]
Determining pathologic complete remission under study treatment
Complete list of historical versions of study NCT00527449 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Rate of breast conserving operations
  • Response to treatment
  • Determinig the therapy associated toxicity
Not Provided
Not Provided
 
Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Breast Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00527449
3305000
No
Dieter Lampe, Dr. med., Klinikum Weissenfels
Klinikum Weissenfels
Not Provided
Principal Investigator: Dieter Lampe, Dr. med. Asklepios Krankenhaus Weissenfels
Klinikum Weissenfels
January 2010

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