Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT)
详细描述
This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT) between 2011 and 2016.
The primary end points are overall survival (OS) and progression free survival (PFS) with Kaplan Meier.
This study was approved by Ethical Committee in Dharmais National Cancer Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •IIIB/C and IV stage of breast cancer
- •received neoadjuvant hormonal therapy or neoadjuvant chemotherapy
- •had first and second biopsy (surgery) within 6 months
排除标准
- •had mastectomy before treatment
- •disagree to enter the study
- •had been given hormonal therapy or chemotherapy before study
- •had contra-indication of SOB for pre-menopausal patients
研究组 & 干预措施
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
干预措施: Aromatase Inhibitors (Arimidex) (Drug)
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
干预措施: Tamoxifen (Drug)
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
干预措施: SOB (Procedure)
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
干预措施: Aromatase Inhibitors (Femara) (Drug)
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
干预措施: Aromatase Inhibitors (Aromasin) (Drug)
Neoadjuvant chemotherapy
Neoadjuvant chemotherapy: FAC 6 cycles
干预措施: FAC (Drug)
结局指标
主要结局
Overall survival
时间窗: time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years
length of time from the date of pathological diagnosis until death from any cause
次要结局
- Progressive free survival(time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years)