Analysis of Clinical Outcome, Predictive and Prognostic Factors of Therapeutic Responses in Patients Who Treated With Doxorubicin & Docetaxel Neoadjuvant Chemotherapy in Clinical Stage II or III Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- pathologic complete response
研究概览
简要总结
Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer.
The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pathologically-confirmed breast cancer by core needle biopsy,
- •initial clinical stage II or III,
- •objective measurable lesion,
- •ECOG performance 0~2,
- •previously untreated,
- •adequate bone marrow, hepatic, cardiac, and renal functions
- •agreement with this trial, and written informed consent
排除标准
- •history of other cancer
- •active infection
- •psychologic disease
- •uncontrolled heart diseases
研究组 & 干预措施
docetaxel + doxorubicin
The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks.
干预措施: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) (Drug)
结局指标
主要结局
pathologic complete response
时间窗: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
The primary end point of this trial was evaluating pathologic complete response (pCR) rate. After 3 cycles of neoadjuvant chemotherapy, patients were undertook breast surgery. Using post operative pathology specimen, we evaluated pathologic response and calculated pCR rate.
次要结局
- survival (Relapse-free survival, overall survival)(2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy)
- early metabolic response(before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle))
- predictive factors(after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy))
- hematologic toxicity(every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy))
研究者
Seock-Ah Im
Professor
Seoul National University Hospital