NCT06405295Enrolling By Invitation不适用
A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年5月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- iDFS%
研究概览
简要总结
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG score 0-1
- •BRCA1/2 mutation
- •No distant metastases assessed by imaging after surgical treatment
- •Breast cancer that is non-pCR after neoadjuvant therapy, or postoperative pathology suggestive of ≥pT2, or ≥pN1
- •Have completed postoperative adjuvant chemotherapy and/or radiotherapy
- •No major organ dysfunction
排除标准
- •Patients who are unable to take oral medication, or who refuse this medication regimen
- •Already enrolled in another study, or less than or equal to 4 weeks from discontinuation of another medication
- •Presence of severe dysfunction of vital organs
- •Patients with other malignancies (with the exception of cured non-melanoma skin cancers, carcinoma in situ of the cervix and other tumours that have been cured for at least 5 years)
- •Acute infectious disease or active chronic infectious disease
- •History of uncontrolled epilepsy, central nervous system disease or mental disorder
结局指标
主要结局
iDFS%
时间窗: 3 years
次要结局
- DRFS%(3 years)
- OS%(3 years)
研究者
PENG YUAN
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL)HODGKIN LYMPHOMANCT00795613Ospedale Santa Croce-Carle Cuneo450
已完成
3 期
Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and ToleranceGraves Disease (Basedow's Disease)NCT01295333Assistance Publique Hopitaux De Marseille200
招募中
3 期
Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal CarcinomaEsophageal Squamous Cell CarcinomaNCT04009265Fujian Medical University Union Hospital819
已完成
3 期
Tamoxifen +/- GnRH Analogue vs Aromatase Inhibitor + GnRH Analogue in Male Breast Cancer PatientsMale Breast CancerNCT01638247German Breast Group56
已完成
2 期
Efficacy and Safety of Early Combined Therapy With PCSK9 Inhibitors and Statins in Acute Ischemic StrokeAcute Ischemic StrokeNCT06696820Xiang Luo429