臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 11, 2024
Last modified on	Mar. 11, 2024
Trial ID	jRCT1030230687

Scientific Title	Study on clinicopathological characteristics and prognosis of ER-low positive breast cancer using National Clinical Database-Breast Cancer Registry (ER low positive breast cancer in NCD)
Public Title	Study on clinicopathological characteristics and prognosis of ER-low positive breast cancer using National Clinical Database-Breast Cancer Registry (ER low positive breast cancer in NCD)

Contact for Scientific Queries	Name	Hayashida Tetsu
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi Shinjuku Tokyo
	Telephone	+81-3-3353-1211
	E-mail	tetsu@keio.jp
Contact for Public Queries	Name	Nagayama Aiko
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi Shinjuku Tokyo
	Telephone	+81-3-3353-1211
	E-mail	anagayama@keio.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 11, 2024
Actual date of first enrollment
Target sample size		200000
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients with primary breast cancer registered in the NCD 2. Patients with Stage I-III breast cancer who have undergone surgery
	Exclusion Criteria	1. non-invasive carcinoma (Tis) 2. Stage IV at diagnosis 3. Metastatic or recurrent breast cancer 4. Occult breast cancer (T0, TX) 5. HER2-positive breast cancer (immunostaining or FISH) 6. Male breast cancer 7. Synchronous or non-synchronous bilateral breast cancer 8. Preoperative radiotherapy cases
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Breast cancer
Intervention(s)
Health Condition(s) Keyword		ER low positive breast cancer
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Disease-free survival, Breast Cancer Specific Survival, and Overall Survival in tumors with ER<1%, 1%<=ER<10%, and ER>=10%, respectively Disease-free survival, Breast Cancer Specific Survival, and Overall Survival with and without perioperative endocrine therapy and chemotherapy in tumors with 1%<=ER<10
Secondary Outcome(s)		Disease-free survival, Breast Cancer Specific Survival, and Overall Survival with perioperative chemotherapy regimens (anthracycline alone, taxane alone, anthracycline + taxane) in tumors with 1%<= ER<10 Survival, Breast Cancer Specific Survival, Overall Survival Clinico-pathological background (age, premenopausal/postmenopausal, histology, stage, lymph node metastasis, PgR, surgery type, perioperative treatment, pathological complete response (pCR) rate in preoperative chemotherapy cases) for ER<1%, 1%<=ER<10% and ER>=10%, respectively

Primary Sponsor	NA

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Institutional review board of Keio University School of Medicine
Address	35 Shinanomachi Shinjuku Tokyo, Tokyo
Telephone	+81-3-3353-1211
E-Mail	med-rinri-jimu@adst.keio.ac.jp
Approval Status	Approval
Date of approval	Oct. 14, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none