Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.

NCT06364267 | Recruiting Phase 2 DMC

• 2 other identifiers: BabyTears2024-520004-26-00
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast cancer, menopause, exemestane, tamoxifen, MenQol, Low dose; babytam, babyexe

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (10)

• Sex hormones

  12 months

• MenQol score domain

  6 months

• Sex hormones

  6 months

• Other domains of MenQol

  6 and 12 months

• Safety profile

  6 and 12 months

Other Outcomes (8)

• MMG risk score

  12 months

• MMG density

  12 months

• HOMA

  6 and 12 months

Study Arms (2)

ARM 1

EXPERIMENTAL

BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 months.

Drug: Exemestane 25 MG

ARM 2

EXPERIMENTAL

BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months

Drug: Tamoxifen 10 MG

Interventions

Tamoxifen 10 MG DRUG

Blinded tamoxifen 10 mg every other day

ARM 2

Exemestane 25 MG DRUG

Blinded exemestane 25 mg every other day

ARM 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrea DeCensi: lead
• Dana-Farber/Brigham and Women's Cancer Center: collaborator
• Herbert Irving Comprehensive Cancer Center: collaborator
• Istituto Europeo di Oncologia: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

E.O. Ospedali Galliera

Genova, Italy, 16128, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Andrea U De Censi, MD

  Ente Ospedaliero Ospedali Galliera

  STUDY CHAIR

Central Study Contacts

Andrea U De Censi, MD

CONTACT

+39.010.563.4501; andrea.decensi@galliera.it

Davide S Corradengo, SC

CONTACT

+39.010.563.4580; davide.corradengo@galliera.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Medicin Department and Oncology Division

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 15, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)