ACTRN12607000011482已完成3 期
HERA: A randomised three-arm multi-centre comparison of 1 year and 2 years of Herceptin® versus no Herceptin® in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,482
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status = 1; Non-metastatic operable primary invasive adenocarcinoma of the breast that is: histologically confirmed, adequately excised, axillary node positive or negative, and tumour size =T1c according to TNM; Known hormone receptor status (ER/PgR or ER alone); Patient must have received at least four cycles of an approved (neo-) adjuvant chemotherapy regimen; Baseline LVEF = 55% measured by echocardiography or MUGA scan after completion of all (neo-) adjuvant chemotherapy and radiotherapy); Completion of radiotherapy for any patients undergoing radiotherapy; Overexpression of HER2 in the invasive component of the primary tumour, according to one of the following definitions: 3+ overexpression by IHC or 2+ overexpression by IHC AND fluorescence in situ hybridisation (FISH) test demonstrating c-erbB2 gene amplification, or c-erbB2 gene amplification by FISH; Completion of all necessary baseline lab and radiologic investigations; Signed written informed consent
排除标准
- •History of any prior (ipsi- and/or contralateral) invasive breast carcinoma; Past or current history of malignant neoplasms, except for curative treated: basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix; Any clinical” T4 tumour, including inflammatory breast cancer; Maximum cumulative dose of doxorubicin >360mg/m2 or maximum cumulative dose epirubicin > 720mg/m2 or any prior anthracyclines unrelated to the present breast cancer; (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support; Any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer; Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or patients with supraclavicular lymph node involvement; Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer; Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, immunotherapy, and bisphosphonate therapy; Serious cardiac illness or medical conditions including but not confined to: History of documented congestive heart failure (CHF), high-risk uncontrolled arrythmias, angina pectoris requiring antianginal medication, clinically significant valvular heart disease, evidence of transmural infarction on ECG, poorly controlled hypertension; Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness; Any of the following abnormal laboratory tests immediately prior to randomisation: serum bilirubin > 2.0 x upper limit of normal (ULN), alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) > 2.5 x ULN, alkaline phosphatase (ALP) > 2.5 x ULN, serum creatinine > 2.0 x ULN, total white blood cell count (WBC) < 2500/mm3, absolute neutrophil count < 1500/mm3, platelets <100,000/mm3; Pregnant or lactating women; Women of childbearing potential or less than one year after menopause (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment.
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