A Pilot Prevention Study of the Effects of the Anti-progestin Ulipristal Acetate (UA) on Surrogate Markers of Breast Cancer Risk

UHSM0315

The primary objective of this study is to determine the effects of the antiprogestin ulipristal acetate (UA) on the epithelial and stromal compartments of the normal breast in women at increased risk of breast cancer (BC) and to relate these effects to quantitative changes on multiparametric magnetic resonance imaging (MRI). The goal is to define predictive imaging biomarkers for subsequent testing in randomised prevention trials of antiprogestins.

2016-01-22

2019-03-18

2023-01-25

Completed

Early phase I

24

Inclusion Criteria: * Premenopausal females aged between 25 and 45 years * Regular menses * 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 40-50 years * Ovulatory menstrual cycles * eGFR ≥ 40mls/min/1.73m2 Exclusion Criteria: * Personal history of breast, uterine, cervical or ovarian cancer * Breast feeding within the last 3 months * Pregnant or planning for pregnancy in the next 6 months. * Known hypersensitivity to radiological contrast media or to ulipristal acetate or its excipients * Current treatment with: Anti-estrogens, GnRH analogues or hormonal contraceptives, corticosteroids or antiplatelet/anticoagulant therapy or moderate or potent inhibitors or inducers of CYP3A4 * APTT and PT outside the normal institutional ranges. Hb \<100g/l and platelet count \<150x109/l. Serum creatinine, bilirubin, ALT, ALP or LDH \>1,5xULN. * Contraindications to MRI * Prior breast enhancement/augmentation surgery * Genital bleeding of unknown aetiology

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-05-06