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

未提供0 个研究点目标入组 250 人开始时间: 待定

适应症

试验速览

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•Aged 18 years or older, Japanese, female or male at the time of informed consent (or at death for
•deceased patients)
•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.
•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.
•Patients who have undergone gBRCA testing with BRACAnalysis at the time of informed consent
•Patients who provided written informed consent where feasible, or an appropriate opt-out approach
•was taken for this study

•Patients who had HER2 positive breast cancer
•Patients who had non-invasive breast cancer (Ductal carcinoma in situ / Lobular carcinoma in situ)
•Patients who did not undergo biopsy prior to NAC and achieved pCR

发起方

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