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

Study Overview
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Brief Summary
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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. 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. Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.

Official Title
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Study of Quality of Life Post Preventive Salpingo-oophorectomy in Healthy BRCA1/2 and PALB2 Mutation Carriers

Conditions
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Hereditary Breast and Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 30 and 49 years 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: Personal history of oophorectomy for benign or malignant ovarian pathology. Personal history of breast cancer.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy<br>Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy | |
| Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy<br>Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy | |
| Cohort 2: without preventive salpingo-oophorectomy<br>Healthy carriers who decide not to proceed to preventive surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy | Questionnaire to measure quality of life in post-menopausal women (the Mencav questionnaire). This questionnaire consists of questions with 5 possible answers, answer 1 is the worst result and question 5 is the best result, so low scores mean worse results and high scores better results. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the impact of hormone replacement therapy on number and description of cardiovascular events | To describe cardiovascular risk we used changes in the weight of patients. Weight in kilograms, height in meters and weight and height will be combined to report BMI in kg/m^2. | 5 years | 
| To compare the impact of hormone replacement therapy on number and description of cardiovascular events | To describe cardiovascular risk we used changes in blood pressure (mmHg) | 5 years | 
| To compare the impact of hormone replacement therapy on number and description of cardiovascular events | To describe cardiovascular risk we used changes in lipids levels (cholesterol, triglycerides, HDL, LDL and VLDL) | 5 years | 
| To compare the impact of hormone replacement therapy on number and description of cardiovascular events | To describe cardiovascular risk we used eventual cardiovascular adverse events | 5 years | 
| To compare the impact of hormone replacement therapy on number and description of bone loss related events in premenopausal carriers after salpingo-oophorectomy we will perform bone densitometry | By performing bone densitometry we will be able to quantify the number of participants with adverse events related to bone loss (osteoporosis or osteopenia) | 5 years | 
| Comparison of overall cancer survival between women deciding risk-reducing surgery and those rejecting it. | We will analyze and compare the mean of overall survival of women undergoing for risk-reducing surgery and those rejecting it | 5 years | 
| Comparison of mean of breast cancer specific survival between women deciding gynecological surgery and those rejecting surgery. | We will analyze and compare the mean of breast cancer specific survival in women undergoing surgery and those rejecting it. | 5 years | 
| Comparison of gynecologic cancer survival between women deciding preventive surgery and those rejecting it. | We will analyze and compare the mean of gynecologic cancer survival of women undergoing surgery and those rejecting it. | 5 years |