JPRN-jRCT2080224179已完成3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 453
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of HER2-positive breast cancer, and hormonal and PD-L1 status, as documented through central testing of a representative tumor tissue specimen
- •- Primary breast tumor size of > 2 cm by any radiographic measurement
- •- Stage at presentation: T2-T4, N1-N3, M0 as determined by AJCC staging system, 8th edition
- •- Pathologic confirmation of nodal involvement with malignancy must be determined by fine needle aspiration or core-needle biopsy. Surgical excision of lymph nodes is not permitted.
- •- Patients with multifocal tumors are eligible provided at least one focus is sampled and centrally confirmed as HER2-positive.
- •- Patients with multicentric tumors are eligible provided all discrete lesions are sampled and centrally confirmed as HER2-positive.
- •- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •- Baseline LVEF >= 55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
- •- Adequate hematologic and end-organ function obtained within 14 days prior to initiation of study treatment
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
- •- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
- •- For patients enrolled in the extended China enrollment phase: current resident of mainland China and of Chinese ancestry (the China subpopulation will consist of patients enrolled at sites in mainland China and Taiwan who are of Chinese ancestry)
排除标准
- •- Prior history of invasive breast cancer
- •- Stage IV (metastatic) breast cancer
- •- Patients with synchronous bilateral invasive breast cancer
- •- Prior systemic therapy for treatment of breast cancer
- •- Previous therapy with anthracyclines or taxanes for any malignancy
- •- Ulcerating or inflammatory breast cancer
- •- Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
- •- Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy
- •- History of other malignancy within 5 years prior to screening, with the exception of those patients who have a negligible risk of metastasis or death
- •- Cardiopulmonary dysfunction
- •- Dyspnea at rest
- •- Active or history of autoimmune disease or immune deficiency
- •- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab/placebo, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, or 7 months after the final dose of trastuzumab, pertuzumab, or trastuzumab emtansine whichever occurs last
- •Exclusion Criteria Related to Trastuzumab Emtansine in the Adjuvant Setting:
- •- Patients who achieved pCR
- •- Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery
- •- Unable to complete surgery with curative intent after conclusion of neoadjuvant systemic therapy
- •- Patient discontinued treatment with trastuzumab because of toxicity during the neoadjuvant phase of the study
- •- Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, or sclerosis cholangitis
- •- Patients with Grade >=2 peripheral neuropathy
- •- Prior treatment with trastuzumab emtansine
研究者
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