Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- objective response rate (ORR) evaluated by MRI
研究概览
简要总结
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.
详细描述
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be signed；
- •Eastern Cooperative Oncology Group Performance Status: 0~1;
- •Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer;
- •Age ≥18 years old；
- •No distant metastatic disease；
- •The disease condition is stage II or stage III;
- •Laboratory exam criteria for enrollment: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2 times ULN, TBIL, CCr≤1.5 times ULN.
排除标准
- •Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- •Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation).
- •Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ
- •Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
- •Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes.
- •Patients who had myocardial infarction in the past 12 months.
- •Patients who participate in other clinical trail.
- •Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.
研究组 & 干预措施
Tucidinostat and Exemestane
Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.
干预措施: Tucidinostat (Drug)
Tucidinostat and Exemestane
Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.
干预措施: Exemestane (Drug)
Tucidinostat and Exemestane
Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.
干预措施: Ovarian function suppression (Drug)
结局指标
主要结局
objective response rate (ORR) evaluated by MRI
时间窗: Up to 31 weeks
ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators using MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST)
次要结局
- objective response rate (ORR) evaluated by CEUS(Up to 31 weeks)
- pathologic complete response rate (pCR)(Up to 31 weeks)
- Adverse effect (AE)(Up to 31 weeks)
- Residual Cancer Burden (RCB)(Up to 31 weeks)
研究者
Ying Lin
Vice Director of Department of Breast Surgery
First Affiliated Hospital, Sun Yat-Sen University