NCT02040935已完成3 期
HOMERUS: A Local, Open Label, Multicentre, Phase IIIB Study, Investigating Subcutaneous Trastuzumab Administered at Home With Single Injection Device in Patients With HER2-Positive Early Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
研究概览
简要总结
This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
- •HER2-positive disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Hormonal therapy will be allowed as per institutional guidelines
- •Prior use of anti-HER2 therapy will be allowed
- •Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
- •No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- •Use of concurrent radiotherapy will be permitted
- •Completion of surgery and chemotherapy (if applicable)
排除标准
- •History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years
- •Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
- •Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- •Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
- •Pregnant or lactating women
- •Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
- •Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
- •Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
- •Inadequate hepatic or renal function
研究组 & 干预措施
Trastuzumab
Experimental
Participants will receive 600 milligrams (mg) trastuzumab SC by SID every 3 weeks (Q3W) for up to a total of 1 year, unless disease recurrence, unacceptable toxicity or participant withdrawal occurs. The first 3 administrations will be done at hospital, after that participants will be permitted to self-administer under the supervision of a healthcare professional (HCP).
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
时间窗: From Baseline up to approximately 4 years
次要结局
- Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab(Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days))
- Health Survey Short Form-36 (SF-36) Score(Cycles 3 and 9 (cycle length=21 days))
- Mood and Anxiety Questionnaire (MASQ) Score(Cycles 3 and 9 (cycle length=21 days))
- Percentage of Participants Choosing to Return to Hospital Administration(Cycle 6 (cycle length=21 days))
研究者
研究点 (17)
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