EUCTR2015-001587-19-GBActive, not recruitingPhase 1
A pilot prevention study of the effects of the anti-progestin Ulipristal Acetate (UA) on surrogate markers of breast cancer risk - Breast Cancer - Anti-Progestin Prevention Study 1
Manchester University NHS Foundation Trust0 sites30 target enrollmentStarted: July 20, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Premenopausal females aged between 25 and 45 years
- •Regular menses defined as date of onset of last menstrual period +/- 3 days of expected
- •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 defined as serum progesterone =15nmol 7 days prior to expected onset of menses.
- •eGFR = 40mls/min/1.73m2 in view of requirement for gadolinium contrast MRI scans
- •Willing and able to provide informed consent to undergo all trial procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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. Pregnancy must be excluded with serum ßhCG <5nmol during screening.
- •Known hypersensitivity to radiological contrast media or to ulipristal acetate or any of its excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, talc, magnesium stearate)
- •Current treatment with:
- •Anti-estrogens (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 least 6 months and regular menstrual cycles resumed.
- •Corticosteroids at any dose, these must have been stopped for at least 1 month with low likelihood that retreatment will be required
- •Antiplatelet or anticoagulant therapy – must have been stopped for at least 7 days and clotting be at satisfactory levels (see below)
- •moderate or potent inhibitors of CYP3A4 (for list see appendix)
- •potent inducers of CYP3A4 (for full list see appendix 1)
- •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, such as intracranial aneurysm clips, implanted electrical devices and intra-ocular metallic foreign bodies.
- •Co-morbidity that would put the patient at increased risk such as recognised bleeding diathesis, moderate to severe hepatic impairment, moderate or severe renal impairment (eGFR <40 ml/min/1.73m2), severe asthma not adequately controlled with corticosteroids (note steroid usage precludes trial entry)
- •Prior breast enhancement/augmentation surgery
- •Genital bleeding of unknown aetiology
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