Clinical Trials

JBCRG-01

Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer

Status
Study Closed

Objectives
The purpose of this study is to evaluate the feasibility and safety as well as clinical and pathological response of cyclophosphamide, epirubicin and fluorouracil (CEF) followed by docetaxel (DOC) as primary systemic chemotherapy in patients with operable breast cancer.

Subjects

Endpoints
Primary endpoint: Clinicl response, pathologic response, safety, Secondary endpoints: Breast-conserving rate, overall survival, disease free survival

Trial Period
June 2002 - May 2009 (Registration: 2 years, follow-up study: 5 years)

Lead Principal Investigator
Yuichi Takatsuka (Department of Breast Surgery, Kansai Rosai Hospital), Masakazu Toi (Department of Surgery, Breast Surgery, Graduate School of Kyoto University)

Target Sample Size
202

Regimen
FEC100 q3w x4->Doc75 q3wx4

Source of Funding
ACRO: Advanced Clinical Research Organization

Conference Presentation
The effect of pathological response of multicenter phase II trial of fluorouracil, epirubicin, cyclophosphamide (FEC 100) followed by docetaxel (DOC 75) in primary operable breast cancer.

Articles and Publications
Comparison of different definitions of pathologic complete response in operable breast cancer; a pooled analysis of three prospective neoadjuvant studies of JBCRG Unargued issues on the pathological assessment of response in primary systemic therapy for breast cancer. Docetaxel Followed by Fluorouracil/Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy for Patients With Primary Breast Cancer PhaseII study of preoperative sequential FEC and docetaxel predicts of pathological response and disease free survival Unargued issues on the pathological assessment of response in primary systemic therapy for breast cancer. Update results of FEC followed by docetaxel neoadjuvant trials for primary breast cancer Interim analysis of a phaseII trial of cyclophosphamide, epirubicin and 5-fluorouracil (CEF) followed by docetaxel as preoperative chemotherapy for early stage breastcarcinoma

UMIN-ID
C000000011

jRCT

Memo

COI Disclosure

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