EUCTR2016-000435-41-IT进行中（未招募）1 期
Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced/Inflammatory HER2-positive Breast Cancer (ImmunHER) - ImmunHER protocol
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)0 个研究点目标入组 60 人开始时间: 2020年12月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Previously untreated, infiltrating primary breast cancer with locally advanced, inflammatory, or early stage tumor (either greater than 2 cm in diameter or node positive) with no evidence of metastatic disease.
- •HER2 positivity (either immunohistochemistry 3+ or fluorescent in situ hybridization amplification).
- •Age 18 or older.
- •Eastern Cooperative Oncology Group performance status of 0 to 1.
- •Availability of tumor tissue for biologic and molecular examination before starting primary treatment.
- •Left ventricular ejection fraction within the institutional range of normal.
- •Normal organ and marrow function.
- •Adequate contraception methods for women of childbearing potential.
- •Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years.
- •Written informed consent.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Either stage I or IV breast cancer.
- •Prior trastuzumab or pertuzumab.
- •Any prior chemotherapy.
- •Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
- •Undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) <= 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
- •Breast radiotherapy prior to starting study.
- •Known hypersensitivity to the investigational drugs or any of their excipients.
- •Evidence of any disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or puts the patient at high risk for treatment-related complications.
- •Moderate/severe hepatic impairment (Child-Pugh B/C).
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Concurrent malignancy or malignancy within 3 years prior to study enrollment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
- •Pregnancy or breastfeeding (breast feeding should be discontinued to be enrolled in the study).
- •Women of childbearing potential that refusal to adopt adequate contraceptive measures.
- •Unwilling or unable to comply with the protocol.
研究者
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