ACTRN12614000694617Completed未知
A pre-operative window study evaluating the biological effects of the RANK-Ligand(RANKL) inhibitor Denosumab on normal breast tissue from BRCA1 and BRCA2mutation carriers
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Melbourne Health
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 18 Years to 50 Years (—)
- Sex
- Female
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
Investigators
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