NCT04236310Unknown2 期
A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER-Positive, HER2-Positive Breast Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 主要终点
- Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy
研究概览
简要总结
To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
- •Age at diagnosis ≥18 years and ≤75 years, female.
- •Histologically confirmed diagnosis of Unilateral ER+/HER2+ breast cancer. ER-positivity is defined as >1% stained cells；HER2-positivity is defined as IHC 3+ or if IHC scored 2+, in-situ hybridisation (ISH) suggests amplified HER2 gene.
- •Tumor diameter >2 centimeters with the clinical stage being classified as from IIa to IIIc.
- •ECOG ≤ 1, LVEF ≥ 55%.
- •Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥1.5 × 109 / L and platelets ≥100 × 109 / L and hemoglobin ≥90 g/L; for hepatic function, total bilirubin ≤1.5 × UNL, AST and ALT ≤2.5 × UNL; for renal function, SCr ≤1.5 × UNL.
排除标准
- •Evidence of bilateral invasive breast cancer or metastatic disease (M1).
- •Pevious treatment with chemotherapy, hormonal therapy, an investigational drug for any type of malignancy, or radiation therapy.
- •Any of the following exist in the last 6 months: known or suspected congestive heart failure (≥ NYHA II), persistent arrhythmias (≥ grade 2), atrial fibrillation of any grade, coronary / peripheral bypass, symptomatic congestive heart failure, cerebrovascular accidents (including transient cerebral hemorrhage attacks or symptomatic pulmonary embolism).
- •Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.
- •Active infection or severe symptomatic visceral disease in the last 4 weeks.
- •Patients with HIV infection or known AIDS, or patients with infection of active hepatitis B (HBV DNA ≥1000IU / ml) or hepatitis C (hepatitis C antibody is positive and HCV RNA is above the lower limit of detection of the analytical method).
- •Prior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
- •Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
- •Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
- •Not eligible for the trial assessed by the investigators of our study.
研究组 & 干预措施
SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression
Experimental
干预措施: SHR6390 (Drug)
SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression
Experimental
干预措施: Anastrozole (Drug)
SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression
Experimental
干预措施: Pyrotinib (Drug)
SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression
Experimental
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy
时间窗: 2 weeks
Ki67 changes from baseline to at 2 weeks after the start of the neoadjuvant therapy
次要结局
- Ki67 changes from baseline to at surgery(average 19 weeks after the start of the neoadjuvant therapy)
- Pathological complete response (ypT0/is ypN0) rate(average 19 weeks after the start of the neoadjuvant therapy)
- Objective response rate (ORR)(average 19 weeks after the start of the neoadjuvant therapy)
- Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped(during treatment (16 weeks))
- Invasive disease-free survival (IDFS)(5 years)
研究者
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Unknown
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