2024-513734-38-00招募中3 期
BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation
Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group, Alliance Foundation Trials LLC, Institut Catala D'oncologia, University Of Manchester, Shaare Zedek Medical Center, ANZ Breast Cancer Trials Group Limited14 个研究点 分布在 3 个国家目标入组 1,150 人开始时间: 2024年8月14日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,150
- 试验地点
- 14
- 主要终点
- Time to the occurrence of any breast cancer (invasive or DCIS)
研究概览
简要总结
To evaluate the reduction in the risk of any breast cancer (invasive or DCIS) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (Variant class 4 or 5)
- •Age ≥ 25 years and ≤ 55 years at randomization
- •No evidence of breast cancer by MRI or MG and clinical breast examination within the last 6 months prior to randomization
- •No clinical evidence of ovarian cancer at randomization
- •Negative pregnancy test at randomization for women of childbearing potential
- •No preventive breast surgery planned at time of randomization
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Written informed consent before any study-specific procedure is performed
排除标准
- •Prior bilateral mastectomy
- •Participant has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction ≤ 3 months prior enrollment
- •Concurrent treatment with a bisphosphonate or an anti-angiogenic agent
- •Concurrent therapy with other Investigational Products
- •Any major medical or psychiatric condition that may prevent the participant from completing the study
- •Known active infection with Hepatitis B virus or Hepatitis C virus
- •Known infection with human immunodeficiency virus (HIV)
- •Hypersensitivity to the active substance or to any of the excipients
- •Known rare hereditary problems of fructose intolerance
- •History of ovarian cancer (including fallopian tube and primary peritoneal cancer)
- •History of breast cancer
- •History of invasive cancer except for basal cell or squamous cell skin cancer. History of the following are also allowed: carcinoma in situ of the cervix, stage 1 papillary or follicular thyroid cancer, atypical hyperplasia or LCIS (Lobular Carcinoma In Situ)
- •Pregnant or lactating women (within the last 2 months prior to randomization)
- •Unwillingness to use highly effective contraception method during and within at least 5 months after cessation of denosumab/placebo therapy in women of childbearing potential
- •Clinically relevant hypocalcaemia (history and current condition), or serum calcium <2.0 mmol/L (<8.0 mg/dL) or corrected calcium (<2.1 mmol/L) Hypocalcemia defined by calcium below the normal range (a single value below the normal range does not necessarily constitute hypocalcemia, but should be 'corrected' before dosing the participant). Monitoring of calcium level in regular intervals (usually prior to IP administration) is highly recommended
- •Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to randomization or for a duration of more than 3 years in total (current and prior HRT is permitted)
- •Any prior use of denosumab
结局指标
主要结局
Time to the occurrence of any breast cancer (invasive or DCIS)
Time to the occurrence of any breast cancer (invasive or DCIS)
次要结局
- Time to invasive breast cancer
- Time to invasive triple negative breast cancer
- Time to ovarian, fallopian tube or primary peritoneal cancer (in women who have not undergone PBSO)
- Time to other (non breast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations
- Time to clinical fractures in pre- and postmenopausal women
- Frequency of breast biopsies and frequency of benign breast lesions
研究者
Trial Office
Scientific
Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group
研究点 (14)
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