Chemotherapy-Free pCR-Guided Strategy With Subcutaneous Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer (PHERGAIN-2)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 393
- 试验地点
- 41
- 主要终点
- 3-year recurrence-free interval (3y-RFI)
研究概览
简要总结
This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous fixed-dose combination) and T-DM1, for patients with previously untreated HER2-positive early breast cancer.
详细描述
Patients ≥ 18 years of age with previously untreated HER2 IHC 3+ invasive carcinoma according to ASCO/CAP 2018 guidelines.
Tumor size between >5 to 30 mm by breast MRI and node-negative status by clinical exam, MRI, and ultrasound. In patients with suspected axillary node involvement, a negative fine needle aspiration biopsy (FNAB) will be mandatory.
Central review for:
Breast MRI. HER2 status. Neoadjuvant treatment will consist In 8 cycles of fixed-dose subcutaneous (SC FDC) HP combination (± ET according to HR status).
urgery will be performed within 4 weeks from the last cycle of HP (sentinel node biopsy will be mandatory; subsequent axillary dissection will be performed according to local guidelines). Surgery will require free margins for any infiltrating or DCIS lesion.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patient HER 2+ IHC 3+
Patients ≥18 years of age with previously untreated HER2-positive (HER2[+]) (Immunohistochemistry [IHC] 3+) invasive carcinoma according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria and tumor size between >5 to 25 mm by breast magnetic resonance imaging (MRI) and node-negative status by clinical exam, MRI, and ultrasound. Patients must have not been previously treated with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy (ET) for invasive breast cancer. Patients with metastatic disease are not eligible. In patients with suspected axillary node involvement, a negative fine needle aspiration biopsy (FNAB) will be mandatory
干预措施: Trastuzumab and Pertuzumab (FDC SC) and T-DM1 (Drug)
结局指标
主要结局
3-year recurrence-free interval (3y-RFI)
时间窗: 3 years
3-year recurrence-free interval (3y-RFI) defined as time from start of treatment in adjuvant setting until recurrence, new invasive disease, or death from breast cancer. Recurrence will be defined in accordance with the standardized efficacy endpoints (STEEP) criteria.
Global health status decline
时间窗: 1 year
Global health status decline rate at 1 year from start of neoadjuvant treatment, defined as the rate of patients with a ≥10% global health status decline at 1 year from start of neoadjuvant treatment as assessed by the Global Health Status/QoL EORTC-QLC-C30 scale and its breast cancer module QLQ-BR23.
次要结局
- Survival rates EFS(3 years and 5 years)
- Survival rates invasive disease-free survival (iDFS)(3 years and 5 years)
- Health-Related Quality of Life (HRQoL) - QLQ-BR23(Baseline up to 5 years)
- pathological complete response (pCR)(after neoadjuvant treatment (8 cycles, an average of 6months))
- Breast-conserving surgery (BCS)(after neoadjuvant treatment (8 cycles, an average of 6months))
- Response rate BCS(after neoadjuvant treatment (8 cycles, an average of 6months))
- Response rate pCR(after neoadjuvant treatment (8 cycles, an average of 6months))
- To evaluate the ratio of patients who have needed chemotherapy.(before T-DM1)
- Survival rates relapse-free interval (RFI)(5 years)
- pathological complete response (pCR) according to hormone receptor (HR) status(after neoadjuvant treatment (8 cycles, an average of 6months))
- Residual cancer burden (RCB)(after neoadjuvant treatment (8 cycles, an average of 6months))
- Survival rates relapse-free survival (RFS)(3 years and 5 years)
- Survival rates disease-free survival (DFS)(3 years and 5 years)
- Health-Related Quality of Life (HRQoL) - QLQ-C30(Baseline up to 5 years)
- Response rate RCB(after neoadjuvant treatment (8 cycles, an average of 6months))
- Survival ratesdistant relapse-free survival (DRFS)(3 years and 5 years)
- Safety adverse events (AEs)(Baseline up to 5 years)
- Survival rates overall survival (OS)(3 years and 5 years)
- Survival ratesbreast cancer-specific survival (BCSS).(3 years and 5 years)
- To assess the cardiac toxicity profile after 1 year of adjuvant treatment(after 1 year of adjuvant treatment)
- To assess the general toxicity profile according to CTCAE v.5.0.(at 3 and 5 year)