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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527449
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : January 15, 2010
Information provided by:
Klinikum Weissenfels

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.

Condition or disease Intervention/treatment Phase
Primary Breast Cancer Drug: Epirubicin, Carboplatin, Docetaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer
Study Start Date : May 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

Primary Outcome Measures :
  1. Determining pathologic complete remission under study treatment [ Time Frame: 28 days after last administration of chemotherapy ]

Secondary Outcome Measures :
  1. Rate of breast conserving operations [ Time Frame: 28 days after administration of last chemotherapy ]
  2. Response to treatment [ Time Frame: 28 days after last administration of chemotherapy ]
  3. Determining the therapy associated toxicity [ Time Frame: 28 days after last administration of chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00527449

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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
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Principal Investigator: Dieter Lampe, Dr. med. Asklepios Krankenhaus Weissenfels

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Responsible Party: Dieter Lampe, Dr. med., Klinikum Weissenfels Identifier: NCT00527449     History of Changes
Other Study ID Numbers: 3305000
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors