EUCTR2013-003839-30-NL进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
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
- •-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 cycles of 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 1300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
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 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 and lymphomas (without bone marrow involvement) diagnosed = 5 years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
- •- Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- •-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
研究者
相似试验
进行中（未招募）
1 期
Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer.Adjuvant breast cancerMedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003839-30-DEAstraZeneca AB1,800
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.Breastcancer10006232NL-OMON47654Astra Zeneca40
进行中（未招募）
不适用
Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer.Adjuvant breast cancerMedDRA version: 17.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003839-30-ESAstraZeneca AB1,320
进行中（未招募）
Unknown
A randomised, double-blind, parallel group, placebo controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infantsRespiratory outcomes after premature birth including lower respiratory tract infections and wheeze.RespiratoryISRCTN14019493Cardiff University542
进行中（未招募）
1 期
Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer.EUCTR2013-003839-30-BEAstraZeneca AB1,800