EUCTR2010-022902-41-SE进行中（未招募）1 期
A randomized multicenter, double-blind, placebo-controlledcomparison of chemotherapy plus trastuzumab plus placeboversus chemotherapy plus trastuzumab plus pertuzumab asadjuvant therapy in patients with operable HER2-positiveprimary breast cancer - APHINITY Adjuvant Pertuzumab and Herceptin IN IniTial therapY of breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,804
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
- •- Adult patients. >/= 18 years of age
- •- Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0), or node-negative but with presence of at least one risk factor as defined by the protocol (the latter option only applies to protocol version A. Node-negative patients are NOT allowable under protocol version B.)
- •- Eastern Cooperative Oncology Group (ECOG) performance status - The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). All procedures, including randomization, must occur during this period. The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first.
- •- Known hormone receptor status (estrogen receptor and progesterone receptor)
- •- Baseline LVEF >/= 55%
- •- Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug
- •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 4080
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 720
排除标准
- •- History of any prior (ipsi- and/or contralateral) invasive breast cancer
- •- History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the
- •colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
- •- Any clinical T4 tumor as defined by TNM, including inflammatory
- •breast cancer
- •- Any previous systemic chemotherapy for cancer or radiotherapy for cancer
- •- Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
- •- Concurrent anti-cancer treatment in another investigational trial
- •- Serious cardiac or cardiovascular disease or condition
- •- Pregnant or lactating women
研究者
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