Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 主要终点
- Reduction in Ki-67 labeling index
研究概览
简要总结
The role of early timing of adjuvant chemotherapy was postulated to be particularly important for patients with endocrine non-responsive disease. The role of cytotoxicity during the period of breast surgery itself and immediately after (perioperative chemotherapy) remained unknown. We investigated in a randomized trial the role of perioperative chemotherapy in patients treated with a preoperative chemotherapy for locally advanced breast cancer and compare it to the preoperative chemotherapy without additional cytotoxic therapy during and immediately after definitive surgery. Patients with T2-3 N0-2 M0 breast cancer, with both estrogen receptors (ER) and progesterone receptors (PgR) expressed in less than 20% of tumor cells, or with absence of progesterone receptors, received up to 6 courses of primary systemic therapy with epirubicin 25 mg/m2 intravenously (i.v.) on days 1 and 2, cisplatin 60 mg/m2 i.v. on day 1, and 5-fluorouracil 200 mg/m2 i.v. daily as continuous infusion (ECF). Patients achieving a partial or complete remission were randomized to continue the infusion of fluorouracil until 2 weeks after surgery (perioperative treatment arm) or to stop fluorouracil infusion one week before surgery, on day 21 of the sixth cycle (control arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer histologically proven > 2 cm, ER and PgR <20% or Any ER and PgR absent (T2,T3 N0-2, M0)
- •No treatment with previous chemotherapy/hormonotherapy
- •Performance status 0-2 (ECOG scale, Appendix 2)
- •Measurable or evaluable lesions
- •Age between 18-70 years
- •No significant intercurrent illness such as diabetes, cardiovascular, renal or neurologic impairments
- •Absence of psychiatric illness
- •WBC > 4,000/mm3; PLTS > 100,000/mm3
- •AST, ALT, LDH, gamma-GT < 2.5 x upper limit of normal and bilirubin < 3 mg/100 ml
- •Informed consent obtained
- •Pregnancy test (in fertile women). An effective contraceptive method must be utilized by fertile women.
- •Baseline examinations (chest X ray, CT scan, ECG etc) performed within one month prior initiation to therapy
排除标准
- •Uncontrolled infection and metabolite disease
- •Distant metastases
- •Active peripheric and/or central neurological disease
- •Active cardiac disease defined as CHF (NYHA III-IV) significant arrhytmias, bilateral bundle branch block or recent (less than 3 months) history of myocardial infarction
- •History of second malignancy (exception in situ carcinoma of the uterine cervix and basal or squamous cell carcinoma of the skin)
结局指标
主要结局
Reduction in Ki-67 labeling index
次要结局
- Pathological complete remission rate
- Disease-free survival
- Toxicity and safety
