Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- pCR Rates
研究概览
简要总结
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.
The purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery
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
- •Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)
- •Endocrine therapy for the current breast cancer may be started within 28 days prior to trial enrollment and must be initiated prior to C2 of chemotherapy/HER2 directed therapy
- •Choice of endocrine therapy will be determined by the treating and/or enrolling physician
- •Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP
- •Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy
排除标准
- •Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults.
- •Patients with non-breast cancer within prior 2 years
- •Patients with breast cancer within prior 5 years
- •Patients with recurrent breast cancer
- •Patients with stage IV breast cancer
研究组 & 干预措施
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
干预措施: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy (Drug)
结局指标
主要结局
pCR Rates
时间窗: 21 months
To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes
次要结局
- RCB scores(21 months)
研究者
Nathalie Johnson
Principal Investigator
Legacy Health System