EUCTR2020-003973-23-IT进行中（未招募）1 期
A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants with Either HER2-Negative BRCA--Mutated or Triple-Negative Breast Cancer with Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST) - Niraparib vs Placebo in Participants with HER2- BRCAmut breast cancer or TNBC with Detectable ctDNA
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 800 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants are eligible to be included in the study
- •if all following criteria are met:
- •1.Stage I to III breast cancer per AJCC for breast cancer staging criteria
- •8th edition with surgical resection of the primary tumor that is
- •confirmed to be either:
- •TNBC,irrespective of BRCA status
- •HR+/HER2- BC with a known and documented tBRCA
- •2.Completed prior standard therapy for curative intent,including all the following,:neoadjuvant treatment,surgery,adjuvant radiotherapy,and adjuvant chemotherapy
- •3.Participants with HR+ BC must be on a stable regimen of
- •endocrine therapy,if indicated,for at least 3 months prior to enrollment.
- •Ovarian suppression,if indicated,must also have been started at least 3
- •months prior to enrollment.
- •4.Detectable ctDNA as measured by central Signatera testing.
- •5.An archival tumour tissue specimen of the primary tumor sufficient in
- •quality and quantity
- •( minimum fifteen 5µm sections or 1 FFPE tumur block for ctDNA
- •assay design and tBRCA testing and minimum 1 FFPE tumur block
- •for HRD testing)is required.
- •6.An Eastern Cooperative Oncology Group performance status of
- •7.Must be =18 years of age.
- •8.Must have adequate organ and bone marrow function, as defined
- •below.If these criteria are not met, randomization and treatment may
- •be delayed up to 3 weeks.
- •Absolute neutrophil count:=1,500/µL
- •Platelets:=100,000/µL
- •Hemoglobin:=9g/dL or 5.6mmol/L
- •Serum creatinine:<2×ULN
- •Total bilirubin:=3×ULN
- •ALT:=2.5×ULN
- •Note:complete blood count should be obtained without
- •transfusion or receipt of colony stimulating factors within 4 weeks prior
- •to obtaining the sample.Participants with current active liver or biliary
- •disease are excluded(with the exception of Gilbert's syndrome or
- •asymptomatic gallstones or otherwise stable chronic liver disease per
- •Investigator assessment).
- •9.Participants with toxicity from prior cancer therapy must have
- •recovered to Grade 1(A participant with Grade 2 neuropathy or Grade 2
- •alopecia is an exception to this criterion and may qualify for this study.).
- •Randomization and treatment may be delayed up to 3 weeks to allow for
- •this criterion to be met.
- •10.Must be able to swallow and retain orally administered study
- •11.A female participant is eligible if she is not pregnant or breastfeeding,
- •and at least 1 of the following conditions applies:
- •Is not a woman of childbearing potential(WOCBP), as defined in
- •Appendix 4.
- •Is a WOCBP and using a contraceptive method that is highly effective
- •,as defined in Appendix 4,during the Treatment Period and for at least
- •180 days after the last dose and agrees not to donate
- •Eggs for the purpose of reproduction during this period.
- •The Investigator should evaluate the effectiveness of the contraceptive
- 另有 12 项未显示
排除标准
- •Participants are excluded from the study if any of
- •following criteria are met:
- •1.Prior treatment with a PARP inhibitor.
- •2.Current treatment with a CDK4/6 inhibitor or endocrine therapy other
- •than anastrozole,letrozole,exemestane,and tamoxifen.
- •3.Participants have any sign of metastasis or local recurrence after
- •comprehensive assessment conducted per protocol.
- •4.Participants have shown no definitive response to preoperative
- •chemotherapy by pathologic or radiological evaluation,in cases where
- •preoperative chemotherapy was administered(see Appendix 1).
- •5.Participants have systolic BP>140mmHg or diastolic BP>90mmHg.
- •6.Participants have any clinically significant gastrointestinal
- •abnormalities that may alter absorption such as malabsorption
- •syndrome or major resection of the stomach and/or bowels.
- •7.Participants have received colony-stimulating factors(eg, granulocyte
- •macrophage colony-stimulating factor or recombinant erythropoietin)
- •within 4 weeks prior to the first dose of study treatment.
- •8.Participants have previously or are currently participating in a
- •treatment study of an investigational agent within 4 weeks of the first
- •dose of therapy preceding the study.
- •9.Participants have received live vaccine within 30 days of planned start
- •of study randomization.The use of live
- •COVID-19adenoviral vaccines within 30 days of randomization must
- •be discussed with the Medical Monitor.
- •10.Participants have known hypersensitivity to the components of
- •niraparib,placebo,or their formulation excipients.
- •11.Participants have undergone major surgery within 4 weeks of starting
- •the first dose of study treatment or have not recovered from any effects
- •of any major surgery.
- •12.Participants have a second primary malignancy.Exceptions are the
- •Adequately treated nonmelanoma skin cancer,curatively treated in situ
- •cancer of the cervix,ductal carcinoma in situ of the breast,Stage
- •I Grade 1 endometrial carcinoma
- •Other solid tumors and lymphomas(without bone marrow involvement) diagnosed =5 years prior to randomization and treated
- •with no evidence of disease recurrence and for whom no more than 1 line of chemotherapy was applied
- •13.Participants have current active pneumonitis or any history of
- •pneumonitis requiring steroids(any dose)or immunomodulatory
- •treatment within 90 days of planned start of the study.
- •14.Participants have any clinically significant concomitant disease or
- •condition(such as transfusion-dependent anemia or thrombocytopenia)
- •that could interfere with,or for which the treatment might interfere
- •with,the conduct of the study or that would,in the opinion of the
- •Investigator,pose an unacceptable risk to the participants in this study.
- •15.Participants have any psychological,familial,sociological,or
- •geographical condition potentially hampering compliance with the study
- •requirements and/or follow up procedures.Those conditions should be
- •discussed with the participants before study entry.
- •16.Participants have high medical risk due to a serious,uncontrolled
- •medical disorder;nonmalignant systemic disease;or active,uncontrolled
- •infection(including COVID-19).
- 另有 6 项未显示
研究者
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