Clinical Trials

JBCRG-13

A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer.

Status
Study Closed

Objectives
To evaluate the efficacy and safety of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil, epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer.

Subjects

Endpoints
Primary endpoint:Pathological complete response rate Secondary endpoints:Overall response rate, Safety, Breast conservation rate, Overall surival, Disease-free survival

Trial Period
Jan 2010-Dec 2012
Registration: 2 years
Follow-up: 5 years from LPI

Lead Principal Investigator
Norikazu Masuda (Dept of Surgery, Osaka National Hospital)

Target Sample Size
40

Regimen
Metronomic PCX+FEC

Source of Funding
JBCRG

Conference Presentation
A phase II study of metronomic paclitaxel/cyclophosphamide/capecitabine followed by 5-fluorouracil/epirubicin/cyclophosphamide as preoperative chemotherapy for triple-negative or low hormone receptor expressing/HER2-negative primary breast cancer (JBCRG-13)

Articles and Publications
A phase II study of metronomic paclitaxel/cyclophosphamide/capecitabine followed by 5-fluorouracil/epirubicin/cyclophosphamide as preoperative chemotherapy for triple-negative or low hormone receptor expressing/HER2-negative primary breast cancer

UMIN-ID
UMIN000003570

jRCT

Memo

COI Disclosure

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