EUCTR2020-001943-21-DE进行中（未招募）1 期
eoOn – Neoadjuvant treatment of Ontruzant® (SB3) in patients with HER2-positive early breast cancer: An open-label, multicenter, phase IV study - NeoOn
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
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
- Female
入选标准
- •In order to be eligible for participation in this trial subject must fulfil all of the following criteria:
- •1. Written informed consent prior to beginning of trial specific procedures.
- •2. Subject must be female and aged = 18 years on day of signing informed consent.
- •3. ECOG 0-1.
- •4. Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion.
- •5. Measurable tumor lesion with a size of = 1 cm assessed by sonography or magnetic resonance imaging (MRI) within = 28 days prior to entry. In case of inflammatory disease, the extent of inflammation will be measured.
- •6. Indication for chemotherapy.
- •7. Multicentric and/or multifocal disease as well as synchronous bilateral breast cancer is eligible as long as one measurable lesion meets all inclusion criteria. The investigator has to determine which lesion will be used for tumor evaluation before initiation of treatment.
- •8. Complete staging within 8 weeks prior to entry with no evidence of distant disease, including bilateral mammography, breast ultrasound, chest-X-ray (or chest CT-scan), liver ultrasound (or liver CT-scan or liver MRI) and bone scan.
- •9. Subjects must provide a core biopsy from tumor lesion before first chemotherapy and after last neoadjuvant study treatment for biomarker analyses.
- •10. Adequate organ function defined by laboratory values.
- •11. Female subjects of childbearing potential must have a negative urine pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the study through 7 months after the last dose of trial treatment.
- •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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •The subject must be excluded from participating in the trial in following cases:
- •1. Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer.
- •2. Known hypersensitivity to Ontruzant® or any of the drug excipients.
- •3. Prior chemotherapy, radiation therapy or small molecule therapy for any reason.
- •4. Previous malignant disease being disease-free for less than 3 years (except in situ carcinoma of the cervix and basal cell carcinoma of the skin).
- •5. Pregnancy or breast-feeding.
- •6. Prior neoadjuvant therapy.
- •7. Active infection requiring systemic therapy.
- •8. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •9. Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs (physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed).
- •10. History of primary or acquired immunodeficiency (including allogenic organ transplant).
- •11. Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis).
- •12. Known history or positive antibody test for any of the following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C, has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- •13. Known congestive heart failure > NYHA I and/or coronary heart disease, angina pectoris, previous history of myocardial infarction, uncontrolled or poorly controlled arterial hypertension (e.g. blood pressure >160/90 mmHg under treatment with two or more antihypertensive drugs), rhythm disorders with clinically significant valvular heart disease.
- •14. Pre-existing motor or sensory neuropathy of a severity grade =2 by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- •15. Any other condition in opinion of the investigator that would interfere with applied systemic treatment or other trial procedures.
研究者
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