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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-12

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hereditary Breast and Ovarian Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Cohort 2: without preventive salpingo-oophorectomy

Healthy carriers who decide not to proceed to preventive surgery

No interventions assigned to this group

Eligibility Criteria

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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.