Clinical Trials

JBCRG-07

Phase II study of combination therapy of preoperative Letrozole and low-dose Metronomic Cyclophosphamide for postmenopausal / hormone receptor positive breast cancer

Status
Study Closed

Objectives
Evaluation of the response rate and the pathological response for primary site or measurable involved lymph nodes, and the safety of neoadjuvant LC (Letrozole combined with metronomic cyclophosphamide) for postmenopausal women with hormone receptor positive, operable and primary breast cancer.

Subjects

Endpoints
Primary endpoint: Response rate, Secondary endpoints: Pathological CR rate, Breast Conserving Surgery rate, Safety, Disease-free survival and Overall survival

Trial Period
October 2007 - March 2015 (Registration: 2.6 years, Follow-up study: 5 years)

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

Target Sample Size
40

Regimen
Letrozole + Cyclophosphamide 24w

Source of Funding
Japan Breast Cancer Research Group (JBCRG)

Conference Presentation
A multicenter phase II trial of neoadjuvant letrozole plus low dose cyclophosphamide in postmenopausal patients with estrogen receptor-positive breast cancer (JBCRG07): the efficacy and its correlation with circulating endothelial cells.

Articles and Publications
A multicenter phase II trial of neoadjuvant letrozole plus low-dose cyclophosphamide in postmenopausal patients with estrogen receptor-positive breast cancer (JBCRG-07): therapeutic efficacy and clinical implications of circulating endothelial cells

UMIN-ID
UMIN000001331

jRCT

Memo

COI Disclosure

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