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Completed

NCT Number: NCT00527449

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Krankenhaus St. Elisabeth u. St. Barbara, Halle, Saxony-Anhalt, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epirubicin, Carboplatin, Docetaxel

Drug

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 outcomes

  1. Determining pathologic complete remission under study treatment

    Time frame: 28 days after last administration of chemotherapy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Klinikum Weissenfels

Other

Registry information

Official study title

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

Acronym: ETCat01

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2007
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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