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

AstraZeneca AB0 个研究点目标入组 1,500 人开始时间: 2014年6月24日最近更新: 2016年2月1日

适应症

试验速览

暂无简介。

•- 18 years old and older
•- Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:
•a) TNBC ER and PgR negative AND HER2 negative (not eligible for anti HER2 therapy)
•b) ER and/or PgR positive, HER2 negative ER and/or PgR positive AND HER2 negative (not eligible for anti-HER2 therapy)
•-Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
•- Completed adequate breast and axilla surgery.
•- Completed at least 6 of 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 0-1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 500

•- 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 malignancy. EXCEPTIONS are:
•a) 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
•b) other solid tumours including lymphomas (without bone marrow involvement) diagnosed = 5 years prior to randomization and treated with not evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
•- Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.-Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing
•- Evidence of metastatic breast cancer

发起方