2023-503994-39-00进行中（未招募）2 期
Low dose TamOxifen and LifestylE changes for bReast cANcer prevenTion: a randomized phase II biomarker trial in subjects at increased risk (TOLERANT Study)
Istituto Europeo Di Oncologia S.r.l.5 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Post intervention levels of circulating Sex Hormone Binding Globulin (SHBG)
研究概览
简要总结
The main aim is to verify whether Low Dose Tamoxifen (LDT) increases circulating Sex Hormone Binding Globulin (SHBG) more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months of intervention
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 18 and 70 years old
- •Healthy participants carriers of a germline pathogenic/likely pathogenetic variant in at least one of the following genes BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C or RAD51D, or > 5% BC risk at 10 years, using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models, or with previous diagnosis of intraepithelial neoplasia (surgery for ADH, LCIS, ER positive DCIS) within the last 3 years
- •Ability to understand and the willingness to sign a written informed consent document.
- •ECOG performance status ≤1 (Karnofsky ≥70%)
- •5a. For high risk strata: A negative mammogram or any radiological image based on age and center protocol screening within 6 months before baseline visit
- •5b. For IEN Strata: A bilateral mammogram within 12 months before baseline visit is required. The diagnostic mammogram (i.e. before breast surgery) is acceptable
- •A negative transvaginal ultrasound/hysteroscopy within 6 months before baseline visit. Women with a previous hysterectomy due to a benign condition, are not required a transvaginal ultrasound.
排除标准
- •Diagnosis of ER negative (<10%) DCIS, or history of breast invasive cancer
- •No hormonal contraception is allowed during study intervention. Non-hormonal methods will be advised for women of childbearing potential (WOCBP).
- •Previous treatment with SERMs or any other hormonal treatment for breast neoplasms
- •BMI < 18.5 Kg/m2 and/or Malnutrition Universal Screening Tool (MUST) score ≥2 and/or any current or past eating disorders
- •Any diagnosis of invasive neoplasia, except non-melanoma skin cancer, in the previous 5 years
- •Any tamoxifen contraindications (abnormal liver function, previous ischemic heart disease, endometrial disorder, previous deep venous thrombosis, history of pulmonary embolus, current or suspected glaucoma, retinopathy or cataract)
- •Current use of warfarin or other anticoagulant drugs
- •Bilateral mastectomy
- •Pregnancy or desire to become pregnant in the subsequent 9 months after treatment cessation
- •Diabetes or any other clinical condition that at the investigator’s discretion contraindicates the proposed intervention
结局指标
主要结局
Post intervention levels of circulating Sex Hormone Binding Globulin (SHBG)
Post intervention levels of circulating Sex Hormone Binding Globulin (SHBG)
次要结局
- Changes in time of serum biomarkers: SHBG, insulin, glucose, lipid profile, IGF-I, IGFBP-1, -2 and -3, hs-CRP, adiponectin and leptin;
- Changes in time of safety and toxicity
- Changes in time of quality of life
- Changes in time of BMI and body composition
- Changes in time of microbiome composition
- Changes in time of immune modulation by expression of inflammation cell signaling genes
研究者
Bernardo Bonanni
Scientific
Istituto Europeo Di Oncologia S.r.l.
研究点 (5)
Loading locations...
相似试验
已完成
2 期
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTionCDH1 Gene MutationRAD51C Gene MutationPALB2 Gene MutationDuctal Carcinoma in SituLobular Carcinoma in SituRAD51D Gene MutationBRCA MutationATM Gene MutationCHEK2 Gene MutationNCT06033092European Institute of Oncology110
已完成
不适用
Impact of Low-dose Tamoxifen on BPUHigh Background Uptake on MBINCT02979301Mayo Clinic22
尚未招募
2 期
A study to check the outcomes of Triple Negative Breast Cancer patients with the presence of Estrogen receptor Beta and TP53 mutation and the outcomes of adding the drug Tamoxifen in these patients.Malignant neoplasm of breast of unspecified site,CTRI/2023/09/057359NAVNEET KAILASH AGRAWAL100
进行中（未招募）
3 期
Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-upCarcinoma, Intraductal, NoninfiltratingRecurrence, Local NeoplasmBreast NeoplasmsAtypical HyperplasiaNCT01357772Andrea DeCensi500
已完成
不适用
A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6Breast CancerNCT00900744Icahn School of Medicine at Mount Sinai121