EUCTR2012-004879-38-DE进行中（未招募）1 期
A RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM, PHASE III NEOADJUVANT STUDY EVALUATING TRASTUZUMAB EMTANSINE PLUSPERTUZUMAB COMPARED WITH CHEMOTHERAPY PLUS TRASTUZUMAB AND PERTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 432
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
- •- age = 18 years
- •- Histologically confirmed invasive breast cancer with a primary tumor
- •size of > 2 cm
- •- HER2-positive breast cancer
- •- Patients with multifocal tumors (more than one tumor confined to the
- •same quadrant as the primary tumor) if all discrete lesions are sampled
- •and centrally confirmed as HER2-positive
- •- Stage at presentation: cT2-cT4, cN0-cN3, cM0
- •- Known hormone receptor status of the primary tumor
- •- Patient agreement to undergo mastectomy or breastconserving surgery
- •after neoadjuvant therapy
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •- Adequate organ function as specified per protocol
- •- Baseline LVEF = 55% measured by echocardiogram (ECHO) or
- •multiple-gated acquisition (MUGA)
- •- Effective contraception as defined by protocol
- •- Documentation of Hepatitis B and Hepatitis C serologies.
- •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 368
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •- Stage IV (metastatic) breast cancer
- •- Patients with a history of invasive breast cancer
- •- Patients who have received prior anti-cancer therapy for breast cancer
- •except those patients with a history of breast lobular carcinoma in situ
- •(LCIS) that was surgically managed or ductal carcinoma in situ (DCIS)
- •treated exclusively with mastectomy. In case of prior history of
- •LCIS/DCIS, >5 years must have passed from surgery until diagnosis of
- •current breast cancer
- •- Patients with multicentric (multiple tumors involving more than 1
- •quadrant) or bilateral breast cancer
- •- Patients who have undergone incisional and/or excisional biopsy of
- •primary tumor and/or axillary lymph nodes
- •- Axillary lymph node dissection or positive sentinel lymph node prior to
- •start of neoadjuvant therapy
- •- History of concurrent or previous non-breast malignancies except for
- •appropriately treated (1) non-melanoma skin cancer and (2) in situ
- •carcinomas, including cervix, colon, and skin. A patient with previous
- •invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years
- •- Treatment with any investigational drug within 28 days prior to
- •randomization
- •- Current National Cancer Institute Common Terminology Criteria for
- •Adverse Events (NCI CTCAE) v4.0 Grade >/= 2 peripheral neuropathy
- •- Major surgical or significant traumatic injury within 28 days prior to
- •randomization
- •- Any significant concurrent medical or surgical conditions or findings
- •that would jeopardize the patient's safety or ability to complete the
- •- Cardiopulmonary dysfunction as defined per protocol
- •- Pregnancy or breastfeeding.
研究者
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