EUCTR2017-000676-29-NL进行中（未招募）1 期
Tailoring neoadjuvant therapy in hormone receptor positive, HER2 negative, luminal breast cancer. - NEOLBC study
BOOG Study Center0 个研究点目标入组 200 人开始时间: 2017年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Postmenopausal women presenting with histological proven (core biopsy material) hormone receptor positive (ER=50%, PR any), HER2 negative, stage II/ III breast cancer.
- •Measurable disease (breast and/or lymph nodes)
- •Adequate bone marrow function (within 4 weeks prior to registration): WBC=3.0x109/l, neutrophils =1.5 x 109/l, platelets =100 x 109/l
- •Adequate liver function (within 4 weeks prior to registration): bilirubin =1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT =2.5 x UNL, Alkaline Phosphatase =5 x UNL
- •Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be =50 ml/min
- •Accessible for treatment and follow-up
- •Written informed consent
- •Randomization specific
- •Registration in the NEOLBC trial before 2 weeks biopsy
- •Use of letrozole
- •Outcome central Ki67 determination in two weeks biopsy available.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Evidence of distant metastases (M1)
- •Previous invasive breast cancer
- •Prior chemotherapy, radiation therapy or hormonal therapy with the exception of patients who received letrozole = 14 days (+ max. 4 days) prior to registration and who are still on letrozole.
- •Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
- •Peripheral neuropathy > grade 2, whatever the cause
- •Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or QTcF =450 msec.
- •Known hypersensitivity reaction to any of the components of the treatment (peanuts, soy)
- •Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment,
- •prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
- •Currently receiving any of the following substances and cannot be discontinued 7 days prior to randomisation:
- •o Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, pomegranate and Seville oranges.
- •o That have a known risk to prolong the QT interval or induce Torsades de Pointes.
- •o That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- •o Herbal preparations/medications, dietary supplements.
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
研究者
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