臨床研究等提出・公開システム

Date of registration	July. 22, 2026
Last modified on	Sept. 01, 2026
Trial ID	jRCT1030260338

Scientific Title	Evaluation of the Respective Clinical Impact of Tumor and Germline BRCA Testing in HER2 negative/High-Risk Early Breast Cancer Patients (ETOILE Study)
Public Title	Evaluation of the Respective Clinical Impact of Tumor and Germline BRCA Testing in HER2 negative/High-Risk Early Breast Cancer Patients (ETOILE Study)

Contact for Scientific Queries	Name	Kitagawa Hiroshi
	Affiliation	AstraZeneca K.K.
	Address	3-1, Ofukacho Kita-ku, Osaka-shi, Osaka
	Telephone	+81-6-4802-3600
	E-mail	hiroshi.kitagawa@astrazeneca.com
Contact for Public Queries	Name	Kawai Daisuke
	Affiliation	AstraZeneca K.K.
	Address	3-1-1, Shibaura, Minato-ku, Tokyo
	Telephone	+81-90-9710-5452
	E-mail	daisuke.kawai@astrazeneca.com

Recruitment status	Pending

Anticipated date of first enrollment		Aug. 01, 2026
Target sample size		250
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Aged 18 years or older, Japanese, female or male at the time of informed consent (or at death for deceased patients) 2. Patients judged as the high-risk of recurrence* after surgery High-risk of recurrence is defined as Stage IIA to IIIC in patients who received neoadjuvant chemotherapy, adjuvant chemotherapy or both. 3. Patients who obtained biopsy tumor samples after 1st September 2021 or formalin-fixed paraffinembedded (FFPE) primary tumor samples* from surgery performed on or after 1st September, 2022; for prospectively enrolled patients, gBRCA testing with BRACAnalysis result and the FFPE specimen for tBRCA testing must be available by Last Patient In (LPI). ** If a patient received neoadjuvant chemotherapy (NAC), submit the pre-NAC biopsy specimen. If a biopsy was not performed, submit the surgical specimen. 4. Patients who have undergone gBRCA testing with BRACAnalysis at the time of informed consent 5. Patients who provided written informed consent where feasible, or an appropriate opt-out approach was taken for this study
	Exclusion Criteria	1. Patients who had HER2 positive breast cancer 2. Patients who had non-invasive breast cancer (Ductal carcinoma in situ / Lobular carcinoma in situ) 3. Patients who did not undergo biopsy prior to NAC and achieved pCR
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		early breast cancer at high risk of recurrence
Primary Outcome(s)		Proportion of tBRCAm
Secondary Outcome(s)		1.Proportion of tBRCAm present in the patients without gBRCAm 2.Proportion of tBRCAm present in the patients with gBRCAm present 3.Proportion of inconclusive or mutation absent patients for tBRCAm by with and without gBRCAm present 4.Proportion of patients who classified to VUS for tBRCAm by with and without gBRCAm present

Primary Sponsor	AstraZeneca K.K.

Source of Monetary Support / Secondary Sponsor	AstraZeneca K.K.
Secondary Sponsor	Not applicable

Name of Certified Review Board	NPO MINS IRB
Address	5-20-9-401, Mita, Minato-ku, Tokyo, Tokyo
Telephone	+81-3-6416-1868
E-Mail	npo-mins@j-irb.com
Approval Status	Approval
Date of approval	June. 18, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 01, 2026	(this page)	Changes
1	July. 22, 2026	Detail

List of change history