Breast Cancer - Anti-Progestin Prevention Study 1

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Manchester University NHS Foundation Trust; University Hospital of South Manchester NHS Foundation Trust
• Collaborator: University of Manchester
• Treatments: Progestins; Ulipristal acetate

Criteria

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