EXEMESTANE for Breast cancer

Inclusion criteria

• {"criterion_text":"- 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.\n- Negative gynecological examination performed up to 6 months before the trial consent form signature.\n- Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1.\n- Able to swallow oral medications.\n- 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.\n- Ability to understand and willingness to sign a written informed consent document.\n- Mammography performed up to 6 months before the trial consent form signature.\n- DEXA performed up to 12 months before the trial consent form signature.\n- Patients with life expectancy >= 10 years.\n- Patients with normal liver function tests and blood cell count."}

Exclusion criteria

• {"criterion_text":"- Pre/perimenopausal women\n- Patients with moderate or severe renal impairment.\n- Patients with a known hypersensitivity to study drugs.\n- History of DVT or PE.\n- Endometrial cancer.\n- Macular disorders.\n- Inability to comply with study procedures.\n- Prior use of antiestrogens within 12 months from the date of the trial consent form signature.\n- Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature.\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Difference between mean change in overall MENQOL (Menopause-Specific Quality of Life Questionnaire) score from baseline to 12 months between the two arms."}

Secondary endpoints

• {"endpoint_text":"- The difference in sex hormones (free estradiol: estradiol/SHBG) and IGF system (IGF-I, IGFBP-3 and their ratio) after 12 months.","definition_or_measurement_approach":"Measurement of sex hormones (free estradiol, estradiol/SHBG) and IGF system markers (IGF-I, IGFBP-3 and their ratio) at 12 months; comparison of differences between arms."}
• {"endpoint_text":"- The difference between arms in the overall MENQOL score after 6 months of treatment.","definition_or_measurement_approach":"Overall MENQOL score at 6 months compared between arms."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Hormone and IGF system measurements at 6 months; MENQOL domain scores (physical, vasomotor, sexual, psychosocial) assessed at 6 and 12 months, comparing arms."}
• {"endpoint_text":"- The difference between arms of toxicity and safety profile according to CTCAE v.5 at 6 and 12 months.","definition_or_measurement_approach":"Adverse events and toxicity graded using CTCAE v5 at 6 and 12 months; comparison between arms."}
• {"endpoint_text":"- The difference between arms at 6 and 12 months in PMAS, Promise Medication Adherence Scale, a validated tool to measure pill adherence.","definition_or_measurement_approach":"Pill adherence measured via PMAS at 6 and 12 months; comparison between arms."}
• {"endpoint_text":"- The difference between arms on BPI Brief Pain Inventory at 6 and 12 months.","definition_or_measurement_approach":"Pain assessed with BPI Short Form at 6 and 12 months; comparison between arms."}
• {"endpoint_text":"- The difference between arms in C-telopetide at 6 and 12 months.","definition_or_measurement_approach":"C-telopeptide levels measured at 6 and 12 months; comparison between arms."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Questionnaire at screening/baseline assessing uptake factors, breast cancer worry, lifestyle risk factors and satisfaction with study explanation."}
• {"endpoint_text":"- Toxicity of babyexe in comparison with full dose historical controls treated in the adjuvant setting will also be evaluated.","definition_or_measurement_approach":"Comparative evaluation of toxicity of babyexe versus historical full-dose adjuvant controls (method: comparison to historical control data)."}

Italy

Earliest CTIS Part Ii Submission Date

09-06-2025

Latest Decision Or Authorization Date

15-07-2025

Processing Time Days

36

Number Of Sites

2

Number Of Participants

70

Portugal

Earliest CTIS Part Ii Submission Date

16-12-2025

Latest Decision Or Authorization Date

03-03-2026

Processing Time Days

77

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

Ente Ospedaliero Ospedali Galliera Di Genova

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Breast Cancer Research Foundation (BCRF)","duties_or_roles":"","organisation_type":""}