Breast Cancer - Anti-Progestin Prevention Study 1

NCT02408770 | Completed Phase 2

• 2 other identifiers: UHSM03152016BS001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• change in the proliferation of normal breast epithelium, assessed by Ki67

  3 months

Secondary Outcomes (3)

• percentage of luminal basal and mixed colonies by adherent and FACS analyses

  3 months

• Change in MRI background parenchymal enhancement assessed by BiRADs scoring

  3 months

• proportion of participants with specific side effects from ulipristal acetate

  monthly to 4 months

Study Arms (1)

treatment

EXPERIMENTAL

ulipristal acetate 5mg daily for 3 months

Drug: ulipristal acetate

Interventions

ulipristal acetate DRUG

selective progesterone receptor modulator

Also known as: Esmya

treatment

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (1)

University Hospitals of South Manchester

Manchester, M204BX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sacha J Howell, MD PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: January 22, 2016
• Primary Completion: March 18, 2019
• Study Completion: January 25, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

GB (1)