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Randomized double blind phase 2 trial of baby exemestane versus baby tamoxifen in postmenopausal women at high risk for breast cancer
EU CTIS ID: 2024-520004-26-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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) 0-1.
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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) 0-1.
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.