NCT06364267招募中2 期
Randomized Double Blind Phase II Trial of Baby Exemestane vs Baby Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
Andrea DeCensi1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Quality of life MEnQol
研究概览
简要总结
The purpose of the study is to to compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life from baseline to 12 months.
详细描述
This is a multicenter, randomized, double blind phase II trial.
Eligible patients will be randomized in a 1:1 ratio to:
ARM 1: BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 monthsor unless progression, SAE, medical decision, patient withdrawal occur.
ARM 2: BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months or unless progression, SAE, medical decision, patient withdrawal occur.
Blinding will be guaranteed by over-encapsulation of active tablet agents with an AA capsule in a 6-month bottle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post- menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •Any of the following criteria must be met:
- •Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (>5%) DCIS (patients with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy) or diagnosis within 3 years of HRL (ADH, LCIS, ALH), or:
- •At least 3% breast cancer risk at 5 years (or 5% risk at 10yrs) per one of the following risk models: the Breast Cancer Surveillance Consortium risk calculator V3 or Tyrer-Cuzick model V8 or:
- •Known carriers of a germline pathogenic/likely pathogenetic variant in the following moderate penetrance genes (CHEK2 or ATM), or women with chest wall irradiation before age of 30 years.
- •Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-
- •Able to swallow oral medications.
- •Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Specifically, all cancers diagnosed since 3 years or longer except for breast and endometrial are eligible.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Mammography performed up to 6 months before the trial consent form signature.
- •DEXA performed up to 12 months before the trial consent form signature.
- •Patients with life expectancy ≥ 10 years.
- •Patients with normal liver function tests and blood cell count.
- •Negative gynaecological examination performed up to 6 months before the trial consent form signature.
排除标准
- •Pre/perimenopausal women
- •History of DVT or PE.
- •Endometrial cancer.
- •Macular disorders.
- •Inability to comply with study procedures.
- •Prior use of antiestrogens within 12 months from the date of the trial consent form signature.
- •Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature.
- •Severe osteoporosis (T score ≤ 2.5 at either spine or hip), or recent vertebral fracture (within 6 months) not treated with zolendronic acid or denosumab.
- •Use of terbinafine, quinidine, cinacalcet, rifampicin, phenytonin, carbamazepine, phenobarbital, and St. John's wort, warfarin, erythromycin, cyclosporin, nifepidine and any concomitant coumarin-type anticoagulant therapy.
- •Patients with moderate or severe renal impairment.
- •Patients with a known hypersensitivity to study drugs.
研究组 & 干预措施
ARM 1
Experimental
BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 months.
干预措施: Exemestane 25 MG (Drug)
ARM 2
Experimental
BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months
干预措施: Tamoxifen 10 MG (Drug)
结局指标
主要结局
Quality of life MEnQol
时间窗: 12 months
The primary endpoint is the difference between arms in the score of overall domain of MENQOL after 12 months of treatment.
次要结局
- Sex hormones(6 months)
- MenQol score domain(6 months)
- Other domains of MenQol(6 and 12 months)
- Safety profile(6 and 12 months)
- PMAS(6 and 12 months)
- BPI(6 and 12 months)
- Bone biomarker(6 and 12 months)
- Customer satisfatcion(Screening)
- Exemestane toxicity(12 months)
研究者
Andrea DeCensi
Director of Medicin Department and Oncology Division
Ente Ospedaliero Ospedali Galliera
研究点 (1)
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