EUCTR2013-001161-16-IT进行中（未招募）1 期
ATIONAL PHASE IIIB PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI-CENTRE, OPEN LABEL STUDY TO ASSESS THE SAFETY OF SUBCUTANEOUS TRASTUZUMAB AND MOLECULAR BIOMARKERS IN PATIENTS WITH EARLY AND LOCALLY ADVANCED HER2-POSITIVE BREAST CANCER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ROCHE SPA
- 入组人数
- 240
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
- •1. Female and male patients aged = 18 years
- •2. Signed informed consent before any specific study procedure
- •3. Able and willing to comply with protocol
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0–1
- •5. Pre and post-menopausal status
- •6. HER2-positive disease immunohistochemistry (IHC) 3+ or in situ hybridization (ISH) positive, as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
- •7. Estrogen and progesterone receptor status (ER and PgR) assessed as negative or positive
- •8. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. Stage of disease: T1-4, N0-3, M0. For T1a-b concomitant axillary involvment is required).
- •9. Left ventricular ejection fraction (LVEF) of = 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC
- •10. Availability of formalin–fixed paraffin-embedded (FFPE) tissue block or partial block from diagnostic core biopsy (only neoadjuvant patients) and from surgical specimens (both adjuvant and neoadjuvant patients), with representative invasive part of the tumor for additional biomarker analysis
- •11. Intact skin at site of SC injection on the thigh
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Exclusion Criteria
- •1. History of other malignancy which could affect compliance with the protocol or interpretation of results Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years, are eligible
- •2. Severe dyspnea at rest or requiring supplementary oxygen therapy
- •3. Concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
- •4. Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
- •5. Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •6. Pregnant or lactating women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days prior to the first dose of study drug
- •7. Women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause (unless surgically sterile), and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment. In this study, menopause is defined as a minimum of 12 consecutive months of amenorrhea during which time no other biological or physiological cause had been identified as a potential cause of this state. Examples of adequate contraceptive measures are intrauterine device, barrier method (condoms, diaphragm) also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not acceptable
- •8. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
- •9. Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin® including hyaluronidase, or the adhesive of the SC device (for cohort B), or a history of severe allergic or immunological reactions, e.g. difficulty to control asthma
- •10. No compliance or adherence with the requirements of the protocol
- •11. Inadequate bone marrow function (as indicated by any of the following):
- •a) Absolute neutrophil count (ANC) < 1,500 / mm3 (< 1.5 × 109/L)
- •b) Platelets < 100,000 / mm3 (< 100 × 109/L)
- •c) Hemoglobin < 10 g/dL
- •12. Impaired hepatic function (as indicated by any of the following):
- •a) Serum total bilirubin > 1.5 × upper limit of normal (ULN)
- •b) Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) > 2.5 × ULN
- •c) Alkaline phosphatase (ALP) > 2.5 × ULN
- •13. Inadequate renal function, as indicated by serum creatinine > 1.5 × ULN
- •14. Hormonal treatment concomitant with chemotherapy (allowed in adjuvant phase with adjuvant Trastuzumab SC.)
- •15. Pre-existing motor or sensory neuropathy of Grade >1
研究者
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