A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome

A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome - A Safety Evaluation of RRM for HBOC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034995

Enrollment

Registered

2018-11-26

Start date

2018-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Surgery: Risk Reducing Mastectomy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: A woman diagnosed has a BRCA1 or BRCA2 mutation, without breast cancer occurrence. Performance status (ECOG scale): 0-2 Duration of survival is expected more than 3 months. Written informed consent.

Exclusion criteria

Exclusion criteria: The presence of other active cancers (synchronous double cancers or metachronous double cancers required interventions). The presence of severe symptomatic diseases or active infectious disease. Physicians concludes that the patient participation on this study is inappropriate.

Design outcomes

Primary

Measure	Time frame
Incidence of complications related RRM within 3 months.	—

Secondary

Measure	Time frame
Clinico-pathological characteristics and patients' background of primary breast cancer resected by RRM Incidence and histological characteristics of occult breast cancer for RRM. Exploratory outcome: Incidence of local recurrence and metastatic sites.	—

Countries

Japan

Contacts

Public ContactHiroaki Shima

Sapporo Medical University Hospital Surgery, Surgical Oncology and Science

simahiro@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026