2023-504180-16-00招募中3 期
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01).
AstraZeneca AB, AstraZeneca AB73 个研究点 分布在 8 个国家目标入组 136 人开始时间: 2024年9月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 73
- 主要终点
- Progression-Free Survival defined as time from randomisation until progression per RECIST vl.1 as assessed by BICR, or death due to any cause.
研究概览
简要总结
To demonstrate the superiority of saruparib (AZD5305) + camizestrant relative to physician's choice CDK4/6i + ET, by assessment of progression-free survival PFS in participants with Advanced Breast Cancer
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult females, pre/peri-menopausal and/or postmenopausal, and adult males
- •Histologically or cytologically documented diagnosis of HRpositive, HER2-negative breast cancer
- •Advanced breast cancer with either locally Advanced disease not amenable to curative treatment or metastatic disease
- •ECOG performance status of O or 1 with no deterioration over the previous two weeks
- •FFPE tissue from each participant (written confirmation of the availability can meet the study requirement for randomization) - Documented loss of function mutation in BRCA1, BRCA2,or PALB2, adhering to the following criteria a) Positive pre-existing local germline or tumour tissue result from an accredited laboratory appoved by theSponsor (CAP/CLIA, ISO15189 or equivalent); OR b) Positive result from prospective tumour tissue test performed at a central laboratory
- •Adequate organ and marrow function
排除标准
- •Participants with history of MDS/AML or with features suggestive of MDS/AML
- •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 4weeks of the first dose of study intervention oran anticipated need for major surgery during the study
- •Palliative radiotherapy with a limited field of radiation within 2weeks or with wide field of radiation orto 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: (a) Strong and moderate CYP3A4 inducers/inhibitors(b )Sensitive CYP2B6 substrates(c)Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
- •Participants with any known predisposition to bleeding
- •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: (a)Disease progression s 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy (b)Disease progression </= 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer (c)Disease progression </= 1 year (365 days) from the last dose with aCDK4/6i in the adjuvant setting (d)Disease progression :s; 1 year (365 days) from the last dose of an oral SERD including camizestrant.
- •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 ~ 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
结局指标
主要结局
Progression-Free Survival defined as time from randomisation until progression per RECIST vl.1 as assessed by BICR, or death due to any cause.
Progression-Free Survival defined as time from randomisation until progression per RECIST vl.1 as assessed by BICR, or death due to any cause.
次要结局
- Overall Survival defined as the time from randomisation until the date of death due to any cause.
- Progression Free Survival 2 defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.
- Time to chemotherapy defined as time from randomisation until the start date of the first subsequent chemotherapy treatment after discontinuation of randomised treatment (censoring participants who died prior to initiation of chemotherapy).
- Objective Response Rate defined as the proportion of participants who have a complete or partial response, as determined by BICR per RECIST vl.1.
- Duration of Response defined as the time from the date of first documented response until date of documented progression per RECIST vl.1 as assessed by BICR, or death due to any cause.
- Participant-reported tolerability defined as proportion of all dosed participants reporting different levels of severity of diarrhoea as measured by the diarrhoea single item (EORTCIL237 /IL239/IL240) and different levels of severity of abdominal pain as measured by the abdominal pain single item (EORTCIL237 /IL239/IL240).
- Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ).
- Change from baseline in patient-reported global health status/Qol as measured by the global health status/Qol scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)
- Plasma concentrations of saruparib (AZD5305)
- Plasma concentrations of camizestrant
- Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (73)
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