BRCA-D, a pilot study evaluating a new breast cancer prevention strategy for BRCA1 and BRCA2 mutation carriers

Not Applicable

Completed

• Conditions: Breast cancer; Cancer - Breast; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12614000694617
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-02
• Study Completion: 2020-04-30
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

1. Documented BRCA1 or BRCA2 mutation carriers
2. ECOG 0-1
3. Premenopausal status
4. Serum calcium or albumin adjusted calcium >2.0mmol/L and <2.9 mmol/L
5. Must agree to take Calcium and Vitamin D supplementation
6. Subjects with reproductive potential must be willing to use acceptable methods of effective contraception (with the exception of hormonal contraception)

Exclusion Criteria

1. BRCA1 or BRCA2 variants that are considered to be non detrimental or where pathogenicity is unknown
2. Active breast cancer
3. Previous irradiation of the breast to be studied
4. Previous bilateral oophorectomy
5. Pregnancy and lactation
6. Hormonal contraception (Mirena IUD is allowed) with a washout period of at least 3 months prior to first dose of study drug
7. Endocrine therapy use in the last 6 months for the purpose of risk reduction
7. History of non-breast malignancies within the last 5 years, except cervical carcinoma in-situ, melanoma in-situ, skin BCC or SCC or Stage 1 thyroid cancer
8. Prior history or current evidence of osteonecrosis of the jaw
9. Active dental/jaw condition requiring oral surgery including tooth extraction
10. Previous treatment with denosumab

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Ki67 expression assessed by immunohistochemistry in breast epithelium of BRCA1 mutation carriers.[Between baseline and after 3 months of denosumab ]