2024-520004-26-00招募中2 期
Randomized double blind phase 2 trial of baby exemestane versus baby tamoxifen in post-menopausal women at high risk for breast cancer. BabyTEARS (Baby Tamoxifen or Exemestane Assessment Randomized Study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The primary endpoint is the difference between the mean changes of individual scores (overall MENQOL) between the two arms, where the change is the difference between baseline and 12 months.
研究概览
简要总结
To compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life (overall score of Menopause-Specific Quality of Life Questionnaire - MENQOL) from baseline to 12 months.
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
- 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. In addition, any of the following criteria must be met: a. Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (>5%) DCIS or diagnosis within 3 years of HRL (ADH, LCIS, ALH), or: b. At least 3% breast cancer risk at 5 years (or 5% risk at 10 yrs) per one of the following risk models: the Breast Cancer Surveillance Consortium risk calculator V3 and Tyrer-Cuzick model V8, or: c. Known carriers of a germline pathogenic/likely pathogenetic variant within 5 years in the following moderate penetrance genes (CHEK2 or ATM), or women with chest wall irradiation before age of 30 years.
- •Negative gynecological examination performed up to 6 months before the trial consent form signature.
- •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 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.
排除标准
- •Pre/perimenopausal women
- •Patients with moderate or severe renal impairment.
- •Patients with a known hypersensitivity to study drugs.
- •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 type of coumarin-type of anticoagulant therapy.
结局指标
主要结局
The primary endpoint is the difference between the mean changes of individual scores (overall MENQOL) between the two arms, where the change is the difference between baseline and 12 months.
The primary endpoint is the difference between the mean changes of individual scores (overall MENQOL) between the two arms, where the change is the difference between baseline and 12 months.
次要结局
- The difference in sex hormones (free estradiol: estradiol/SHBG) and IGF system (IGF-I, IGFBP-3 and their ratio) after 12 months.
- The difference between arms in the overall MENQOL score after 6 months of treatment.
- Sex hormones (free estradiol, estradiol/SHBG), IGF system (IGF-I, IGFBP-3 and their ratio) at 6 months. The difference between arms in each of the four individual MENQOL domain scores (physical, vasomotor, sexual and psychosocial) at 6 and 12 months.
- The difference between arms of toxicity and safety profile according to CTCAE v.5 at 6 and 12 months.
- The difference between arms at 6 and 12 months in PMAS, Promise Medication Adherence Scale, a validated tool to measure pill adherence.
- The difference between arms on BPI Brief Pain Inventory at 6 and 12 months.
- The difference between arms in C-telopetide at 6 and 12 months.
- Patient uptake at screening/baseline phase will be measured with a questionnaire including factors related to breast cancer worry and presence of life style risk factors, and participant satisfaction for study explanation.
- Toxicity of babyexe in comparison with full dose historical controls treated in the adjuvant setting will also be evaluated.
研究者
Andrea De Censi
Scientific
Ente Ospedaliero Ospedali Galliera Di Genova
研究点 (2)
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