NL-OMON30125撤回2 期
Study of neo adjuvant chemotherapy in large and/or lymphenode positive breast cancer (stage IIB-III pT2> 3cm). Multicentre - phase II - trial. - Neoadjuvant chemotherapy in large and/or lymphenode positive breast cancer.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Women presenting with locally advanced stage IIB-III breast cancer pT2 > 3 cm, and/or clinically proven N+ disease. Exclusion cT4. (TNM classification 2002).
- •No prior surgery other than biopsy and no prior chemotherapy or radiation therapy.
- •Age > 18 years and age < 60 years.
- •Karnofsky Performance status index > 80%
- •Estrogen and/or progesterone receptor analysis performed on the primary tumour. Results must be known by the end of chemoptherapy in order to decide whether hormonal therapy is indicated.
- •Her2/neu receptor analysis performed on the primary tumour.
- •Adequate bone marrow (within 14 days prior to registration):WBC > 3.0 x 109/l, neutrophils > 1.5 x 109/l, platelets > 100 x 109/l, hemoglobin > 7 mmol/l.
- •Adequate liver function (within 21 days prior to registration):bilirubin < 1 x upper limit of normal (UNL) range, ALAT and/or ASAT < 2.5 x UNL, Alkaline Phosphatase < 5 x UNL.
- •Adequate renal function (within 21 days prior to registration):Creatinine < 120 µmol/L; if limit values reached, the calculated creatinine clearance should be > 60 mL/min.
- •No sign of metastatic disease on X-thorax, liver ultrasound or nuclear bone scan.
- •Cardiac LVEF evaluation by ECHO or MUGA (within normal limits).
- •Patients must be accessible for treatment and follow-up.
- •Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
- •Having signed written informed consent according to the local Ethics Committee requirements.
排除标准
- •Prior systemic anticancer therapy for any cancer (immunotherapy, hormonaltherapy, genetherapy, chemotherapy).
- •Prior anthracycline-based or taxoid-containing therapy (paclitaxel, docetaxel) for any malignancy.
- •Prior radiation therapy for breast cancer.
- •Patients with advanced pulmonary disease.
- •Peripheral neuropathy > grade 2 whatever the cause.
- •Clinical evidence of CNS disease.
- •Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
- •Pregnant or lactating women, or potentially fertile women not using adequate contraception.
- •Clinically T4
研究者
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