EUCTR2015-002811-13-GB进行中（未招募）1 期
Randomised, phase II/III, 3 stage trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in breast cancer patients with TNBC and/or gBRCA - PARTNER
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 527 人开始时间: 2015年12月1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
- 527
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
- •For the PARTNER trial:
- •Written informed consent
- •Aged between 16 and 70
- •Histologically confirmed invasive breast cancer
- •Clinical stage T1-4 N0-2 (tumour or metastatic node diameter > 10mm)
- •Confirmed ER-negative and HER2-negative
- •Germline BRCA mutation positive, irrespective of hormone status but HER2 negative.
- •Performance Status 0-1
- •For the PARTNERING pathway:
- •Previous inclusion and treatment within PARTNER trial
- •Written informed consent (PARTNERING consent)
- •Performance Status 0-1 at registration into PARTNERING
- •Availability of an end of chemotherapy biopsy after cycle 6 and prior cycle 7 of PARTNER treatment
- •Histologically confirmed residual invasive breast cancer at biopsy performed after Cycle 6 of PARTNER therapy
- •Availability of TILs assessment in baseline biopsy prior Cycle 1 AND post Cycle 6 of PARTNER therapy is required
- •Body weight >30kg
- •Adequate bone marrow, hepatic, and renal function
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 506
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •For the PARTNER trial:
- •T0 tumour in absence of axillary node > 10mm
- •TNBC with a non-basal phenotype and over-expressing Androgen Receptor
- •Not suitable for neoadjuvant chemotherapy
- •Distant metastases apparent prior to randomisation
- •Prior history of invasive breast cancer within the last 5 years
- •Previous PARP inhibitor use or any previous chemotherapy or targeted agent
- •Any previous chemotherapy or agent used for the treatment of cancer within the last 5 years
- •For the PARTNERING pathway:
- •Rapidly progressive disease during PARTNER neoadjuvant treatment
- •Tumour cellularity less than 10% in biopsy performed after Cycle 6 of PARTNER therapy.
- •Not suitable for treatment with new agents
- •Persistent AEs from prior anti-cancer therapy =Grade 3
研究者
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