Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment - SASCIA - SASCIA

GBG Forschungs GmbH0 个研究点目标入组 1,200 人开始时间: 2021年5月26日最近更新: 2024年9月2日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GBG Forschungs GmbH
入组人数: 1,200

研究概览入排标准研究者记录与标识符相似试验

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

•Patients with residual invasive disease after neoadjuvant chemotherapy at high risk of recurrence defined by either:
•- For HR-negative: any residual invasive disease > ypT1mi
•- For HR-positive disease: a CPS+EG score = 3 or CPS+EG score 2 and ypN+ using local ER and grade assessed on core biopsies taken before start of neoadjuvant treatment.
•-Patients must have received neoadjuvant taxane-based chemotherapy for 16 weeks (anthracyclines are permitted). This period must include 6 weeks of a taxane containing neoadjuvant chemotherapy (exception: for patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant chemotherapy, a total treatment period of less than 16 weeks is also eligible).
•-An interval of less than 16 weeks since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) and the date of randomization is required
•-Radiotherapy should be delivered before the start of study treatment. Radiotherapy to the breast is indicated in all patients with breast conserving surgery and to the chest wall and lymph nodes
•according to local guidelines as well as in all patients with cT3/4 or ypN+ disease treated by mastectomy.
•-Immune checkpoint inhibitor / immunotherapy during neoadjuvant therapy is allowed.
•-Germline BRCA1/2 mutated or wildtype/unknown.
•-Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block from surgery after neoadjuvant chemotherapy and from core biopsy before start of neoadjuvant
•chemotherapy, which will be used for centralized prospective confirmation of HR status, HER2
•status, Ki-67 and tumor-infiltrating lymphocytes (TILs) and for retrospective exploratory correlation
•between genes, proteins, and mRNAs relevant to sensitivity/resistance to the investigational
•agents. For patients with bilateral carcinoma, FFPE blocks from both sides have to be provided for
•central testing.
•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 1200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1200

排除标准

•-Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible.
•-Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study, including Gilbert´s disease, Crigler-Najjar-Syndrom, known hepatitis B,
•hepatitis C, known HIV positivity or known autoimmune disease (other than diabetes, vitiligo, or
•stable thyroid disease) and infection requiring intravenous antibiotic use within 1 week of enrolment.
•-Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina
•pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of
•prior infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >150/90
•mmHg under treatment with at maximum three antihypertensive drugs), rhythm abnormalities
•requiring permanent treatment (excluding chronic atrial fibrillation not requiring a pacemaker),
•clinically significant valvular heart disease, supraventricular and nodal arrhythmias requiring a
•pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker.
•-Known allergic reactions to irinotecan.

研究者

发起方

GBG Forschungs GmbH

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