jRCT2031240096招募中不适用
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer. (EvoPAR-Breast01)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
- •Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
- •Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
- •ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
- •FFPE tumour tissue from each participant
- •Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
- •Adequate organ and marrow function
排除标准
- •Participants with history of MDS/AML or with features suggestive of MDS/AML
- •Participants with any known predisposition to bleeding
- •Any history of persisting severe cytopenia
- •Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
- •Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection
- •History of another primary malignancy
- •Persistent toxicities (CTCAE Grade more than 2) caused by previous anti-cancer therapy excluding alopecia
- •Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease
- •Evidence of active and uncontrolled hepatitis B and/or hepatitis C
- •Evidence of active and uncontrolled HIV infection
- •Active tuberculosis infection
- •Cardiac criteria, including history of arrythmia and cardiovascular disease
- •Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
- •Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
- •Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment
- •Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET up to 28 days before randomisation
- •Prior treatment within 28 days with blood product support or growth factor support
- •Any systemic concurrent anti-cancer treatment
- •Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:
- •Strong and moderate CYP3A4 inducers/inhibitors
- •Sensitive CYP2B6 substrates
- •Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
- •Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
- •Systemic use of atropine
- •The following exclusion criteria apply to treatments administered for early breast cancer:
- •Disease progression less than 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
- •Disease progression less than 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
- •Disease progression less than 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
- •Disease progression less than 1 year (365 days) from the last dose of an oral SERD including camizestrant.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 59 months
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
次要结局
未报告次要终点
研究者
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