Tamoxifen preventive study

JRCT ID: jRCTs031200222

Registered date:30/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 26/01/2021
• Target sample size: 210
• Study type: Interventional
• Intervention(s): administration of tamoxifen

Outcome(s)

• Primary Outcome: The incidence of breast cancer in women with BRCA2 deleterious mutation after three years of low dose tamoxifen treatment (overall/ER-positive breast cancer)

Secondary Outcome

1) The incidence of non-invasive ductal carcinoma in women with BRCA2 deleterious mutation after three years of low dose tamoxifen treatment(overall/ER-positive ductal carcinoma)
2)Evaluation of tolerability of tamoxifen (incidence of endometrial cancer/ovarian cancer/thrombus/fracture/cardiovascular event)
3) Adverse events and side effects
4) Diagnosis accuracy of breast MRI (BI-RADS(R) category determination)
5) Sensitivity of breast MRI to breast cancer detection
6) Frequency and percentage of malignancy of MRI guided biopsy
7) Relationship between the degree of background parenchymal enhancement (BPE) by breast MRI and the incidence of breast cancer
8) Sensitivity of miRNA and ctDNA to breast cancer detection

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Female

Include criteria

1)Women of age >= 20 and <=70 years at enrollment
2)Women with a confirmed deleterious BRCA2 germline mutation
3)No evidence of breast cancer by mammography and breast ultrasound with latest examination prior to enrollment
4)ECOG performance status (PS) is 0 or 1
5)Women who do not wish or plan for preventive mastectomy
6)Women who have major organ functions
7)Women who have written informed consent to participate in this study
Genetic tests tested outside of Japan will be those that meet CLIA criteria.

Exclude criteria

1)Women who underwent bilateral mastectomy
2)History of invasive breast cancer or non-invasive ductal carcinoma
3)History of invasive cancer except for basal cell carcinoma, spinous cell carcinoma, carcinoma in situ of the cervix, papilla cancer or follicular cancer
4)Any medical or psychiatric condition that may prevent the subject from completing the study
5)Women who are judged inappropriate to participate the study by the investigator

Related Information

• Primary Sponsor: Nakamura Seigo
• Source(s) of Monetary Support: Japan Agency of Medical Research and Development,Donations through crowdfunding,ASFREYA.Inc