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临床试验/EUCTR2019-004100-35-DE
EUCTR2019-004100-35-DE进行中（未招募）1 期

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 1,332 人开始时间: 2020年3月17日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
1,332
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 until the completion of radiotherapy
  • •-Patients with known gBRCA1/2 mutation without indication to adjuvant olaparib therapy are allowed to participate in the trial.
  • •-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 1332
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 1332

排除标准

  • •-Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not
  • •-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
  • •-Patients with known gBRCA1/2 mutation and indicated or planned adjuvant olaparib therapy if available
  • •-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

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