2024-516198-61-00招募中3 期
UNIRAD : Randomised, double-blind, multicentre phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with high risk of relapse, ER+ and HER2- primary breast cancer who remain free of disease
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Unicancer
- 入组人数
- 1,080
- 试验地点
- 50
- 主要终点
- Disease free survival rate (DFS) after randomisation (disease is defined as local, regional or metastatic relapse, a new contralateral breast cancer, or death from any cause).
研究概览
简要总结
To evaluate the benefit on disease-free survival (DFS) from adding 2 years everolimus to standard endocrine treatments.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female ≥ 18 years of age
- •Adequate hematological function (neutrophil count 2x109/l, platelet count 100x 109/l)
- •Adequate hepatic function: AST and ALT ≤ 2.5 ULN, alkaline phosphatases ≤ 2.5 ULN, total bilirubin ≤ 2 ULN.
- •Adequate renal function: serum creatinine ≤ 1.5 ULN
- •Signed written informed consent.
- •Histologically proven invasive unilateral or bilateral breast cancer (regardless of the morphological subtype)
- •Patient with high risk of relapse
- •ER+ and HER2 negative : Hormone receptor positive is defined as any staining on the primary tumor, HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH non-amplified]
- •Primary tumor completely resected (deep margins and overlying skin involvement allowed if fully resected)
- •Patients who will begin an adjuvant hormone therapy or have received a maximum of 4 years of adjuvant hormone therapy. Hormone therapy could be either tamoxifen +/- LH-RH agonists, letrozole, anastrozole or exemestane
- •No clinically or radiologically detectable metastases at time of inclusion.
- •WHO Performance status (ECOG) of 0 or 1.
排除标准
- •Any local or regional recurrence or metastatic disease.
- •Patient with chronic infection
- •Uncontrolled diabetes defined as glycated haemoglobin , HbA1c>7%
- •Uncontrolled hypercholesterolemia (cholesterol >300 mg/dl under adequate therapy).
- •Known hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.
- •Patient with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study (e.g. patient who regularly require systemic steroids to control co-morbid disease).
- •Patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Any clinical or radiological suspicion of malignant or pre-malignant disease in the contralateral breast.
- •Patients with pN1mi as sole nodal involvement
- •Previous cancer (excepted basal cell carcinoma of the skin or in situ carcinoma of the cervix) in the preceding 5 years, including invasive contralateral breast cancer.
- •Patient already included in another ongoing therapeutic trial involving an unlicensed drug for which follow-up is required.
- •Patient who is pregnant or breast-feeding. Adequate birth control measures should be taken during the study treatment phase.
- •Patient with significantly impaired lung function (e.g. Chronic Obstructive Pulmonary Disease, respiratory insufficiency, Interstitial Lung Disease)
- •Positive serology for HIV infection or hepatitis C.
- •Chronic carrier of HBV (positive Antigen HbsAg positive in the blood)
结局指标
主要结局
Disease free survival rate (DFS) after randomisation (disease is defined as local, regional or metastatic relapse, a new contralateral breast cancer, or death from any cause).
Disease free survival rate (DFS) after randomisation (disease is defined as local, regional or metastatic relapse, a new contralateral breast cancer, or death from any cause).
次要结局
- Efficacy : Overall survival rate (OS) for the whole population
- Efficacy : DFS and OS for ER+ and PR+ subgroup
- Efficacy : DFS and OS for the ER+/PR – subgroup
- Efficacy : EFS
- Efficacy : DMFS
- Efficacy : BMFS
- Efficacy : Secondary cancer
- Toxicity : CTC-AE scale version 4.0.
- Biological : Predictive value of mTOR activation markers on DFS: IHC analysis of primary tumor for pS6K and p4EBP
- Biological : Other translational analyses linking cancer biology with outcomes
- Other : Quality of life: QLQ C30
- Other : EFS and DMFS in low risk patients (according to the EPClin score)
- Other : Sociologic study
研究者
Nourredine AIT RAHMOUNE
Scientific
Unicancer
研究点 (50)
Loading locations...
相似试验
进行中（未招募）
1 期
Randomized, double-blind, multicentric phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving 3 years of adjuvant hormone therapywomen with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving 3 years of adjuvant hormone therapyEUCTR2012-003187-44-FRICANCER1,984
进行中（未招募）
1 期
A trial of everolimus in women with breast cancerER+, HER2- early breast cancerMedDRA version: 20.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003187-44-GBICANCER1,984
进行中（未招募）
1 期
Comparative Efficacy and Safety Study of RGB-14-P and Prolia in Women with Postmenopausal OsteoporosisMedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersPostmenopausal osteoporosisEUCTR2020-006017-38-CZGedeon Richter Plc.434
进行中（未招募）
1 期
Comparative Efficacy and Safety Study of RGB-14-P and Prolia in Women with Postmenopausal OsteoporosisPostmenopausal osteoporosisEUCTR2020-006017-38-PLGedeon Richter Plc.434
进行中（未招募）
1 期
Comparative Efficacy and Safety Study of RGB-14-P and Prolia in Women with Postmenopausal OsteoporosisPostmenopausal osteoporosisEUCTR2020-006017-38-BGGedeon Richter Plc.434