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临床试验/NCT00301548
NCT00301548已完成2 期

Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer

European Institute of Oncology0 个研究点目标入组 172 人开始时间: 2000年2月1日最近更新:
适应症
相关药物

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

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

研究者

发起方
European Institute of Oncology
申办方类型
Other

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