臨床研究等提出・公開システム

Date of registration	Dec. 25, 2023
Last modified on	Dec. 25, 2023
Trial ID	jRCT1032230536

Scientific Title	The efficacy and safety of 21-gene assay (Oncotype DX) in neoadjuvant endocrine therapy for postmenopausal breast cancer, single-arm phase II study.
Public Title	The efficacy and safety of 21-gene assay (Oncotype DX) in neoadjuvant endocrine therapy for postmenopausal breast cancer, single-arm phase II study.

Contact for Scientific Queries	Name	Takei Hiroyuki
	Affiliation	Nippon Medical School Hospital
	Address	1-1-5 Sendagi Bunkyo Tokyo
	Telephone	+81-3-3822-2131
	E-mail	takei-hiroyuki@nms.ac.jp
Contact for Public Queries	Name	Takei Hiroyuki
	Affiliation	Nippon Medical School Hospital
	Address	1-1-5 Sendagi Bunkyo Tokyo
	Telephone	+81-3-3822-2131
	E-mail	takei-hiroyuki@nms.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 25, 2023
Target sample size		26
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Women with untreated invasive and hormone receptor positive and HER2 negative breast cancer 2. Postmenopausal state 3. Can be written informed consent
	Exclusion Criteria	1. BRCA1/2 variant 2. Allergy of hormone therapy or contrast agent
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Breast Cancer
Health Condition(s) Keyword		Hormone receptor positive breast cancer, Neoadjuvant endocrine therapy, Oncotype DX
Health Condition(s) Code		D001940
Primary Outcome(s)		The response rate of RECIST The side effect rate of CTCAE
Secondary Outcome(s)		The rate of pathological complete response (ypT0 and Tis) The rate of breast conserving surgery PEPI score

Primary Sponsor	EXACT SCIENCES

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Central ethics committee of Nippon Medical School
Address	1-1-5 Sendagi Bunkyo Tokyo, Tokyo
Telephone	+81-3-3822-2131
E-Mail	c-ethics@nms.ac.jp
Approval Status	Approval
Date of approval	Dec. 01, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none