A pilot prevention study of the effects of the anti-progestin Ulipristal acetate (UA) on surrogate markers of breast cancer risk

niversity Hospital of South Manchester0 sites30 target enrollmentJuly 1, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 1, 2015

End Date

June 30, 2019

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospital of South Manchester

•1\. Premenopausal females aged between 25 and 45 years
•2\. Regular menses defined as date of onset of last menstrual period \+/ 3 days of expected
•3\. Known BRCA1 or BRCA2 mutation or moderate to high risk of developing BC defined as \>17% lifetime risk from age 20 or \>3% risk between 4050 years
•4\. Ovulatory menstrual cycles defined as serum progesterone \=15nmol 7 days prior to expected onset of menses
•5\. eGFR \= 40mls/min/1\.73m2 in view of requirement for gadolinium contrast MRI scans
•6\. Willing and able to provide informed consent to undergo all trial procedures

•1\. Personal history of breast, uterine, cervical or ovarian cancer
•2\. Breast feeding within the last 3 months
•3\. Pregnant or planning for pregnancy in the next 6 months. Pregnancy must be excluded with serum ßhCG \<5nmol during screening.
•4\. Known hypersensitivity to radiological contrast media or to ulipristal acetate or any of its excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, talc, magnesium stearate)
•5\. Current treatment with:
•5\.1\.Antiestrogens (e.g. tamoxifen or raloxifene), GnRH analogue therapy (e.g. goserelin or buserelin) or hormonal contraceptives including androgens such as cyproterone acetate. Such treatments must have been stopped for at least6 months and regular menstrual cycles resumed
•5\.2\.Corticosteroids at any dose, these must have been stopped for at least 1 month with low likelihood that retreatment will be required
•5\.3\.Antiplatelet or anticoagulant therapy – must have been stopped for at least 7 days and clotting be at satisfactory levels
•5\.4\.Moderate or potent inhibitors of CYP3A4
•5\.5\.Potent inducers of CYP3A4