BRCA1 mutation carrier Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10064117 Term: Familial risk factor S
Conditions
Interventions
Product Name: Tamoxifen
Pharmaceutical Form: Tablet
INN or Proposed INN: Tamoxifen
CAS Number: 10540-29-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Produ
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Age >18 years 2. Premenopausal 3. Known pathogenic BRCA1 mutation 4. Intact ovaries 5. No previous breast/ovarian carcinoma 6. No other previous malignancy 7. No previous use of chemoprevention 8. Willingness to use contraception 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. BRCA1 mutation of uncertain significance 2. Personal history of breast or ovarian carcinoma 3. Previous risk-reducing breast or ovarian surgery 4. Post-menopausal status 5. Concomitant use of alternative chemoprevention regimens 6. Concomitant use of other hormonal agents (within one month of trial enrolment) 7. Contraindications to study drug therapies 8. Contraindications to breast core biopsies 9. Pregnancy or breastfeeding 10. Inability to give informed consent 11. Having made a decision to proceed with risk reducing surgery and on surgical waiting list.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the feasibility of trial treatments as a chemopreventive strategy in BRCA1 mutation carriers and compliance.;Secondary Objective: To establish tolerability of trial treatments and procedures.;Primary end point(s): Percentage of patients given PIS who consent to trial entry. Measurement of compliance with treatment using patient medication cards. ;Timepoint(s) of evaluation of this end point: Percentage of patients given PIS who consent to trial entry will be measured at close of recruitment to trial. Measurement of compliance with treatment using patient medication cards will occur daily (patients will record their own compliance). This data will be collected at 2 timepoints: 1. After completion of first treatment arm (Day 84+/-3) 2. After completion of the second treatment arm (Day 196+/-3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measurement of patient Quality of Life using questionnaires. Recording of AEs that occur during treatment. ;Timepoint(s) of evaluation of this end point: Measurement of patent Quality of Life using questionnaires will occur at 3 timepoints: 1. Before the start of treatment (Day 1) 2. After completion of first treatment arm (Day 84+/-3) 3. After completion of the second treatment arm (Day 196+/-3) Recording of AEs will occur as they are reported, and patients will be asked about AEs at every patient contact. | — |
Countries
United Kingdom
Contacts
Public ContactMr Stuart McIntosh
Centre for Cancer Research and Cell Biology
Outcome results
None listed