hereditary breast and ovarian cancer
Conditions
Interventions
 
Standard treatment: RRSO 
o BRCA1 at a maximum age of 40 (advised between age 35 and 40)
o BRCA2 at a maximum age of 45 (advised between age 40 and 45)
Innovative treatment: RRS when childbearing is completed with delayed RRO
and 45).
o BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 
40 and 50). 
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Women with a class 5 (definitely pathogenic) BRCA1 or BRCA2 germline mutation in one of the participating centers. • Age at inclusion; o BRCA1: 25-40 years o BRCA2: 25-45 years • Childbearing completed • Presence of at least one fallopian tube
Exclusion criteria
Exclusion criteria: • Postmenopausal status (natural menopause or due to treatment) • Wish for second stage RRO within two years after RRS • Legally incapable • Prior bilateral salpingectomy • A personal history of ovarian, fallopian tube or peritoneal cancer • Current diagnosis or treatment for malignant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study outcome is high grade serous (ovarian) cancer incidence at the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: • High grade serous (ovarian) cancer incidence at the age of 70 • Incidence of (pre)malignant findings in tubes/ovaries • Peri-operative morbidity and mortality • Incidence of pelvic cancer (other than ovarian cancer) • Breast cancer • Uptake of risk reducing oophorectomy | — |
Countries
Australia, Austria, Belgium, Brazil, Germany, Ireland, Italy, Mexico, Netherlands, Norway, Poland, Spain, Sweden, United States, Uruguay
Contacts
Public ContactT.A. Gootzen
Radboud Universitair Medisch Centrum
Outcome results
None listed