Breast CancerPhase 2BabyTearsNCT06364267
Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
A Phase 2 study testing Tamoxifen 10 MG and Exemestane 25 MG in people with Breast Cancer, run by Andrea DeCensi at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen 10 MG and Exemestane 25 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to 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.
- 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) 0-1.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
E.O. Ospedali Galliera
Genova, Italy, 16128
Andrea De Censi, MD, +390105634501, andrea.decensi@galliera.it
Davide Corradengo, +390105634580, davide.corradengo@galliera.it
About this study
Official title: Randomized Double Blind Phase II Trial of Baby Exemestane vs Baby Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
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.
Read the detailed description
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.
In both arms, treatment should begin within 30 days from randomization. Exemstane and Tamoxifen will be provided for free by the Study Sponsor.
After study completion, participants will be unblinded and treated according to local guidelines. Clinical visit will be performed every 6 months (±14 days) with physical examination vital signs and weight and girth measurement, ECOG PS, MENQOL questionnaire (0, 6, 12 months), review of self-reported compliance, concomitant medications, AEs assessment, and physical exam. Telephone/video contact may be allowed at 3 and 9 months, whereas baseline, 6 months and 12 months visits are necessary for blood collection and biomarker assessment. Blood serum for centralized storage at IEO, Milan, Italy, will be collected at different time points.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen 10 MG, Exemestane 25 MG
- Keywords
- Breast cancer, menopause, exemestane, tamoxifen, MenQol, Low dose, babytam, babyexe
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen 10 MGDrug
Blinded tamoxifen 10 mg every other day
Exemestane 25 MGDrug
Blinded exemestane 25 mg every other day
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 months. Receives: Drug: Exemestane 25 MG |
| ARM 2 | Experimental | BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months Receives: Drug: Tamoxifen 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life MEnQol
The primary endpoint is the difference between arms in the score of overall domain of MENQOL after 12 months of treatment.
Measured: 12 months
Secondary outcomes (10)
Sex hormones
The difference in sex hormones (free estradiol: estradiol/SHBG) and IGF system (IGF-I, IGFBP-3 and their ratio) after 12 months, as surrogate endpoint biomarkers.
Measured: 12 months
MenQol score domain
The difference between arms in the overall MENQOL score domain after 6 months of treatment.
Measured: 6 months
Sex hormones
The difference in sex hormones (free estradiol: estradiol/SHBG) and IGF system (IGF-I, IGFBP-3 and their ratio) after 6 months, as surrogate endpoint biomarkers.
Measured: 6 months
Other domains of MenQol
The difference between arms individual domains of MENQOL (physical, sexual, psychosocial, vasomotor) at 6 and 12 months
Measured: 6 and 12 months
Safety profile
The difference between arms of safety profile according to CTCAE v.5 at 6 and 12 months.
Measured: 6 and 12 months
PMAS
The difference between arms at 6 and 12 months in PMAS, Promise Medication Adherence Scale, a validated tool to measure pill adherence.
Measured: 6 and 12 months
BPI
The difference between arms on BPI Brief Pain Inventory at 6 and 12 months.
Measured: 6 and 12 months
Bone biomarker
The difference between arms in C-telopetide at 6 and 12 months
Measured: 6 and 12 months
Customer satisfatcion
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.
Measured: Screening
Exemestane toxicity
Toxicity of babyexe in comparison with full dose historical controls treated in the adjuvant setting will also be evaluated
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Oct 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea DeCensi
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber/Brigham and Women's Cancer Center, Herbert Irving Comprehensive Cancer Center, Istituto Europeo di Oncologia, Breast Cancer Research Foundation
- Responsible party
- Sponsor-investigator, Andrea DeCensi, Ente Ospedaliero Ospedali Galliera
- Investigators
- Andrea U De Censi, MD, Study chair, Ente Ospedaliero Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364267
- Sponsor's protocol ID
- BabyTears
- Other IDs
- 2024-520004-26-00
- Acronym
- BabyTears
- Status last verified
- Nov 2025
- First submitted
- 8 Apr 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Phase II Trial of Baby Exemestane vs Baby Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
- ClinicalTrials.gov ID
- NCT06364267
- Acronym / sponsor ID
- BabyTears / BabyTears
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, menopause, exemestane, tamoxifen, MenQol, Low dose, babytam, babyexe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Andrea DeCensiUniversity, hospital or other
- Collaborators
- Dana-Farber/Brigham and Women's Cancer Center, Herbert Irving Comprehensive Cancer Center, Istituto Europeo di Oncologia, Breast Cancer Research Foundation
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In both arms, treatment should begin within 30 days from randomization. Exemstane and Tamoxifen will be provided for free by the Study Sponsor.
After study completion, participants will be unblinded and treated according to local guidelines. Clinical visit will be performed every 6 months (±14 days) with physical examination vital signs and weight and girth measurement, ECOG PS, MENQOL questionnaire (0, 6, 12 months), review of self-reported compliance, concomitant medications, AEs assessment, and physical exam. Telephone/video contact may be allowed at 3 and 9 months, whereas baseline, 6 months and 12 months visits are necessary for blood collection and biomarker assessment. Blood serum for centralized storage at IEO, Milan, Italy, will be collected at different time points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Drug: Exemestane 25 MGBabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 months. |
| ARM 2 | Experimental | Drug: Tamoxifen 10 MGBabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- 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 the willingness to sign a written informed consent document.
Key exclusion criteria (11 listed)
- Pre/perimenopausal women
- History of DVT or PE.
- Endometrial cancer.
- Macular disorders.
- Inability to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamoxifen 10 MGBlinded tamoxifen 10 mg every other day | Drug | ARM 2 |
| Exemestane 25 MGBlinded exemestane 25 mg every other day | Drug | ARM 1 |
Primary outcome
Quality of life MEnQol
Time frame: 12 months
The primary endpoint is the difference between arms in the score of overall domain of MENQOL after 12 months of treatment.
10 secondary outcomes
Sex hormones
Time frame: 12 months
MenQol score domain
Time frame: 6 months
Sex hormones
Time frame: 6 months
Other domains of MenQol
Time frame: 6 and 12 months
Safety profile
Time frame: 6 and 12 months
PMAS
Time frame: 6 and 12 months
BPI
Time frame: 6 and 12 months
Bone biomarker
Time frame: 6 and 12 months
Customer satisfatcion
Time frame: Screening
Exemestane toxicity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea U De Censi, MD study chair
Ente Ospedaliero Ospedali Galliera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen 10 MG and Exemestane 25 MG in people with Breast Cancer, run by Andrea DeCensi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea U De Censi, MD (+39.010.563.4501, andrea.decensi@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life MEnQol (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.