NL-OMON54665招募中2 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: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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>=3.0x10^9/l, neutrophils >=1.5 x 10^9/l, platelets >=100 x 10^9/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.
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
- •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
研究者
相似试验
进行中（未招募）
1 期
Tailored therapy, before surgery, in women after the menopause with hormone sensitive breast cancer.Mamma carcinomaMedDRA version: 21.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000676-29-NLBOOG Study Center200
尚未招募
不适用
The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate risk prostate carcinoma (NEO-ONE)prostate cancerprostate carcinoma10038588NL-OMON39212TweeSteden ziekenhuis400
进行中（未招募）
不适用
The effects of pretreatment with androgen blocking hormones before brachytherapy for prostate cancer on the course of PSA and testosterone after treatmentocalized prostate cancerMedDRA version: 14.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004749-41-NLTweeSteden hospital
进行中（未招募）
2 期
Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.Breast NeoplasmsNCT03283384Borstkanker Onderzoek Groep100
已完成
不适用
Investigation of neoadjuvant chemohormonal therapy before robot-assisted radical prostatectomy for the patients with high-risk prostate cancer.Prostate cancerJPRN-UMIN000034906Tottori University Hospital100