Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Enrolling

Conditions: Hereditary Breast and Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05409222

IIBSP-ECV-2019-103

Details and patient eligibility

About

1. Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline HRT.
2. Premenopausal mutation carriers treated with PBSO who choose HRT have a comparable overall survival and specific survival for breast / gynecological cancer to women who undergo surgery and refuse to receive HRT.
3. Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.

Enrollment: 45 estimated patients

Sex: Female

Ages: 30 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 30 and 49 years
2. Being a member of a family with a history of hereditary breast and ovarian cancer, with a cancer risk> 10% or being a carrier of the BRCA1 / 2 or PALB2 mutation.

Exclusion criteria

1. Personal history of oophorectomy for benign or malignant ovarian pathology.
2. Personal history of breast cancer.

Trial design

45 participants in 3 patient groups

Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy

Description:

Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy

Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy

Description:

Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy

Cohort 2: without preventive salpingo-oophorectomy

Description:

Healthy carriers who decide not to proceed to preventive surgery