Efficacy of Endocrine Therapy Compared to Chemotherapy as a Neoadjuvant Treatment for Patients With Hormone Receptor-positive and HER2-negative Breast Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical response rate
研究概览
简要总结
Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.
详细描述
Patients will be randomized into two groups:
The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines.
The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.
- Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for the NET group), the clinical assessment will be performed for all patients.
- All patients will undergo breast magnetic resonance imaging (MRI) before the start of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment before surgery.
- We will determine the objective tumor response with every measurement method and assess the response according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.
- Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group.
- Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment.
- Adverse events will be recorded at every patient visit and will be assessed according to the Common Terminology Criteria for Adverse Events Version 5.0.
- Surgery will be performed between the 24th and 26th week.
- Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted to arm A.
The primary endpoint will be;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Any histological type of invasive breast cancer. All grades of breast cancer (I, II, III). ER-positive and/or PR-positive, HER2-negative breast cancer. ER and/or PR level of positivity ≥34 % (score 4 according to modified Allred score).
- •Clinical Stages: any T N1-3, or T2-4 any N, M0.
排除标准
- •Hormone receptor positivity < 34%. inflammatory breast cancer Metastatic breast cancer. Recurrent breast cancer. Other malignancy. Unfit patients for chemotherapy.
研究组 & 干预措施
Neoadjuvant chemotherapy group
Patients in this arm will receive neoadjuvant chemotherapy as usual
干预措施: Chemotherapy drug (Drug)
Neoadjuvant endocrine therapy group
Patients in this group will receive neoadjuvant endocrine therapy
干预措施: Hormonal Antineoplastics (Drug)
结局指标
主要结局
Clinical response rate
时间窗: 6 months
The primary endpoint will be; The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements according to the (RECIST) version 1.1.
次要结局
- pathological complete response(6 months)
研究者
Amal Ali Omar
Assistant lecturer
Sohag University