Clinical Trials

JBCRG-05

Phase II study of Letrozole and Docetaxel as preoperative chemotherapy in postmenopausal/hormone receptor positive / neo-adjuvant anthracycline refractory primary breast cancer

Status
Study Closed

Objectives
Evaluation of the response rate, the pathological response and the safety of neoadjuvant Letrozole combined with Docetaxel x 4 courses for postmenopausal women with hormone receptor positive, operable and primary breast cancer which confirmed SD or PD in prior anthracycline-containing chemotherapy.

Subjects

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

Trial Period
August 2007 - February 2015 (Registration: 2.5 years, Follow-up study: 5 years)

Lead Principal Investigator
Takahiro Nakayama (Osaka Medical Center for Cancer and Cardiovascular Disease)

Target Sample Size
33

Regimen
Doc75 q3w x4->Letrozole 12(-18)w

Source of Funding
Japan Breast Cancer Research Group (JBCRG)

Conference Presentation

Articles and Publications

UMIN-ID

jRCT
UMIN000001214

Memo

COI Disclosure

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