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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
  Purpose

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.


Condition Intervention Phase
Primary Breast Cancer
Drug: Epirubicin, Carboplatin, Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer

Resource links provided by NLM:


Further study details as provided by Klinikum Weissenfels:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527449

Locations
Germany
Krankenhaus St. Elisabeth u. St. Barbara
Halle, Sachsen-Anhalt, Germany, 06110
Klinikum Marienstift
Magdeburg, Sachsen-Anhalt, Germany, 39110
Asklepios Krankenhaus Weissenfels
Weissenfels, Sachsen-Anhalt, Germany, 06667
Sponsors and Collaborators
Klinikum Weissenfels
Investigators
Principal Investigator: Dieter Lampe, Dr. med. Asklepios Krankenhaus Weissenfels
  More Information

No publications provided

Responsible Party: Dieter Lampe, Dr. med., Klinikum Weissenfels
ClinicalTrials.gov Identifier: NCT00527449     History of Changes
Other Study ID Numbers: 3305000
Study First Received: September 7, 2007
Last Updated: January 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Docetaxel
Epirubicin
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 23, 2014