NCT01817452已完成2 期
A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol
West German Study Group1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Definition of a biomarker (profile) characterizing "good responders" to dual blockade T and P anti-HER2 blockade that have similar pCR rates as patients treated with identical dual anti-HER2 blockade + taxane backbone
研究概览
简要总结
Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without chemotherapy backbone within the ADAPT trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
- •Histologically confirmed unilateral primary invasive carcinoma of the breast
- •Clinical T1 - T4 (except inflammatory breast cancer)
- •All clinical N (cN)
- •No clinical evidence for distant metastasis (M0)
- •Known HR status and HER2 status (local pathology) Tumor block available for central pathology review
- •Performance Status ECOG ≤ 1 or KI ≥ 80%
- •Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
- •Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- •The patient must be accessible for treatment and follow-up
- •Additional Inclusion criteria for participation in the HR-/HER2+ sub-protocol:
- •Confirmed ER and PR negative and HER2+ by central pathology
- •Clinical cT1c - T4a-c (participation of patients with tumors >cT2 is strongly recommended)
- •All clinical N (participation of patients with cN0, if at least cT1c is strongly recommended)
- •Patients must qualify for neoadjuvant treatment
- •LVEF > 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)
排除标准
- •Known hypersensitivity reaction to the compounds or incorporated substances
- •Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
- •Non-operable breast cancer including inflammatory breast cancer
- •Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
- •Male breast cancer
- •Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- •Breast feeding woman
- •Sequential breast cancer
- •Reasons indicating risk of poor compliance Patient not able to consent
- •Additional Exclusion Criteria for participation in the HER2+/HR- sub-protocol:
- •Known polyneuropathy ≥ grade 2
- •Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
- •Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
- •Uncompensated cardiac function (current unstable ventricular arrhythmia requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 6 months of enrollment, history of severe hypertension, CAD - coronary artery disease)
- •Severe dyspnea
- •Abnormal blood values:
- •Thrombocytopenia > CTCAE grade 1
- •Increases in ALT/AST > CTCAE grade 1
- •Hypokalaemia > CTCAE grade 1
- •Neutropenia > CTCAE grade 1
- •Anaemia > CTCAE grade 1
研究组 & 干预措施
Arm A
Experimental
Trastuzumab + Pertuzumab
干预措施: Trastuzumab (Drug)
Arm A
Experimental
Trastuzumab + Pertuzumab
干预措施: Pertuzumab (Drug)
Arm B
Active Comparator
Trastuzumab + Pertuzumab + Paclitaxel
干预措施: Trastuzumab (Drug)
Arm B
Active Comparator
Trastuzumab + Pertuzumab + Paclitaxel
干预措施: Pertuzumab (Drug)
Arm B
Active Comparator
Trastuzumab + Pertuzumab + Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Definition of a biomarker (profile) characterizing "good responders" to dual blockade T and P anti-HER2 blockade that have similar pCR rates as patients treated with identical dual anti-HER2 blockade + taxane backbone
时间窗: After 12 weeks of therapy
pCR will be measured after 12 weeks of randomized treatment.
次要结局
未报告次要终点
研究者
研究点 (1)
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