Clinical Trials

JBCRG-TR01

Study of therapeutic effects of FEC (5-Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel or Docetaxel followed by FEC as preoperative chemotherapy in primary breast cancer and HER2/TOP2A status

Status
Study Closed

Objectives
Evaluation of the relationship between HER2 gene amplification and TOP2A gene amplification, as well as the relationship between the gene amplification and the therapeutic effect of this regimen, by detecting HER2 and TOP2A gene amplification by FISH (Fluoresence in situ hydrization) using samples collected from primary breast cancer patients after preoperative chemotherapy using FEC followed by Docetaxel or Docetaxel followed by FEC

Subjects
Patients who underwent primary breast cancer surgery after preoperative chemotherapy using FEC followed by Docetaxel or Docetaxel followed by FEC and submitted informed consent as a sample donor

Biopsy samples taken at the diagnosis and after the first chemotherapy of the sequential administration, and surgical samples

Endpoints
Patients who underwent primary breast cancer surgery after preoperative chemotherapy using FEC followed by Docetaxel or Docetaxel followed by FEC and submitted informed consent as a sample donor

Trial Period
November 2006 - November 2011 (Registration: 2 years, Follow-up study: 3 years)

Lead Principal Investigator
Masakazu Toi (Department of Surgery, Breast Surgery, Graduate School of Kyoto University)

Target Sample Size
200

Regimen

Source of Funding
Japan Breast Cancer Research Group (JBCRG)

Conference Presentation

Articles and Publications

UMIN-ID

jRCT

Memo

COI Disclosure

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