Tamoxifen preventive study

Not Applicable

Recruiting

• Conditions: Breast cancer; breast cancer, BRCA2, tamoxifen, prevention

• Registration Number: JPRN-jRCTs031200222
• Lead Sponsor: akamura Seigo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 210

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified