NCT02505048已完成2 期
A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Clinical Benefit Rate
研究概览
简要总结
The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.
详细描述
This is a single arm, open-label, multicentric, phase II trial, with a Simon two-stage design, assessing the efficacy of a PARP inhibitor, rucaparib, in 41 progressing breast cancer patients with at least one line of chemotherapy at the metastatic setting., and who are carrying a BRCAness profile defined by Clovis genomic signature or a BRCA1 or 2 somatic mutation, without known BRCA1 or 2 germline mutation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically proven breast cancer.
- •No Her2 over-expression.
- •Progressive metastatic disease previously treated with at least one line of chemotherapy at the metastatic setting.
- •Molecular analysis using the Affymetrix (CytoScan HD, SNP 6.0, or OncoScan) array available from the SAFIR02 protocol, or from other programs.
- •BRCAness profile as defined by the Clovis genomic signature or BRCA1/2 somatic mutation (without known germline BRCA).
- •Age ≥ 18 years
- •WHO Performance Status 0/1
- •Presence of measurable target lesion according to RECIST criteria v1.1
- •Patients will have had at least a 21-day wash-out period from last chemotherapy or targeted therapy administration prior to inclusion and should have recover (grade ≤1) from all residual toxicities, excluding alopecia.
- •Potentially reproductive patients must agree to use an effective contraceptive non-hormonal method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 6 months after the last dose of study drug.
- •Women of childbearing potential must have a negative serum pregnancy test done within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the study drug.
- •Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
- •Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
- •Patient with social insurance coverage.
排除标准
- •BRCA1 or 2 germline known mutation.
- •Life expectancy <3 months.
- •Less than 14 days from radiotherapy (whatever the indication). Fields should not have involved all target lesions.
- •Patients previously treated with a PARP inhibitor.
- •Spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
- •Patients with all target lesions in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them
- •Inability to swallow
- •Major problem with intestinal absorption
- •Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
- •Evidence of severe or uncontrolled systemic disease (active bleeding diatheses, or active Hepatitis B, C and HIV)
- •Previous history of myelodysplastic syndrome
- •History of hypersensitivity to active or inactive excipients of the rucaparib.
- •Toxicities of grade ≥2 from any previous anti-cancer therapy, with the exception of alopecia.
- •Altered haematopoietic or organ function, as indicated by the following criteria:
- •Polynuclear neutrophils <1.5 x 10⁹/L
- •Platelets <100 x 10⁹/L
- •Haemoglobin <90 g/L
- •ALAT/ASAT >2.5 x upper limit of normal (ULN) in the absence of or >5 x ULN in the presence of liver metastases
- •Bilirubin >1.5 x ULN
- •Creatinine clearance ≤30 mL/min (measured or calculated by Cockcroft and Gault formula
- •Women who are pregnant.
- •Patients using drugs that are known potent inhibitors or potent inducers of CYP1A2 or CYP3A4 are not eligible if those treatments cannot be substituted before inclusion
- •Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
- •Individuals deprived of liberty or placed under the authority of a tutor.
研究组 & 干预措施
rucaparib
Experimental
Tablets 200 mg and 300 mg per os : 600 mg / bid every day in continuous.
Patients will be treated with rucaparib Cycles are defined in 28-day periods Disease response will be assessed every 8 weeks (RECIST 1.1) Safety will be assessed continuously
干预措施: rucaparib (Drug)
结局指标
主要结局
Clinical Benefit Rate
时间窗: 3 years
according to RECIST, is either complete response (CR), partial response (PR) or stable disease (SD) lasting for at least 16 weeks
次要结局
- Number of patients with complete response, partial response or stable disease(3 years)
- Progression free survival(3 years)
- Overall Survival(3 years)
- Number of patients experiencing an adverse event.(toxicities will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period)
研究者
研究点 (2)
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