NL-OMON47654已完成3 期
A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. - Olympia
Astra Zeneca0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed non-metastatic primary triple negative invasive
- •adenocarcinoma of the breast.
- •ER and/or PgR positive/HER 2 negative patients
- •Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
- •suspected deleterious (known or predicted to be detrimental/lead to loss of
- •Completed adequate breast and axilla surgery. Completed at least 6 cycles
- •neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the
- •combination of both. Prior platinum as potentially curative treatment for prior
- •cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer
- •is allowed.
- •ECOG performance status 0-1.
排除标准
- •Any previous treatment with a PARP inhibitor, including olaparib and/or known
- •hypersensitivity to any of the excipients of study treatment
- •Patients with second primary cancer, EXCEPTIONS: adequately treated
- •non-melanoma skin cancer, curatively treated in situ cancer of the cervix,
- •Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial
- •carcinoma, or other solid tumours including lymphomas (without bone marrow
- •involvement) curatively treated with no evidence of disease for >= 5 years prior
- •to randomization. More than one course of chemotherapy for previous malignancies
- •Resting ECG with QTc > 470 msec detected on 2 or more time points within a
- •24 hour period or family history of long QT syndrome. If ECG demonstrates QTc
- •>470 msec, patient will be eligible only if repeat ECG demonstrates QTc <=470
- •Whole blood transfusions in the last 120 days prior to entry to the study which
- •may interfere with gBRCA testing
研究者
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