Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Comparison of Low-Dose Exemestane versus Low-Dose Tamoxifen for Breast Cancer Prevention in Postmenopausal Women at High Risk

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying breast cancer prevention in postmenopausal women who are at high risk for developing breast cancer. The study compares two medications at low doses: exemestane (called "babyexe") versus tamoxifen (called "babytam"). Exemestane and tamoxifen are both medications that can affect hormone activity in the body. Postmenopausal refers to women who have not had menstrual periods for at least 12 months.

The purpose of this study is to compare how these two low-dose medications affect quality of life in high-risk women. High-risk factors may include previous abnormal breast findings, family history of breast cancer, certain genetic variations, or previous radiation to the chest area before age 30. The trial is described as "randomized" and "double blind," which means participants will be assigned by chance to receive either babyexe or babytam, and neither the participants nor the researchers will know which medication each person is receiving during the study.

Participants in this study will take their assigned medication and be evaluated at various points, including at 6 months and 12 months after starting treatment. The researchers will assess various aspects of quality of life, including physical symptoms, hot flashes (vasomotor symptoms), sexual health, and psychological well-being. They will also monitor for any side effects and measure certain hormone levels and bone markers in the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Randomization and Medication Assignment

    You will be randomly assigned to receive one of two medications: either low-dose exemestane (also called 'babyexe') or low-dose tamoxifen (also called 'babytam'). Neither you nor your doctor will know which medication you are receiving, as this is a double-blind study.

    Both medications are being studied for their potential to reduce breast cancer risk in postmenopausal women who are at high risk for developing breast cancer.

  2. Step 2

    Baseline Assessment

    Before starting medication, you will complete several questionnaires, including the Menopause-Specific Quality of Life Questionnaire (MENQOL), which measures how menopause-related symptoms affect your quality of life.

    Blood samples will be taken to measure hormone levels, including estradiol (a type of estrogen) and insulin-like growth factor (IGF) system components.

    You will also complete the Brief Pain Inventory (BPI) questionnaire to assess any pain you may be experiencing.

  3. Step 3

    Starting Medication

    You will begin taking your assigned medication (either low-dose exemestane or low-dose tamoxifen) daily according to the instructions provided.

    You will be asked to maintain consistent medication use throughout the 12-month study period.

  4. Step 4

    6-Month Follow-up Visit

    After taking the medication for 6 months, you will return for a follow-up assessment.

    You will complete the same questionnaires as at baseline (MENQOL, BPI).

    Blood samples will be taken again to measure hormone levels and other biomarkers.

    You will be assessed for any side effects using a standardized system called CTCAE (Common Terminology Criteria for Adverse Events).

    Your medication adherence will be evaluated using the Promise Medication Adherence Scale (PMAS), which measures how consistently you've been taking your pills.

    A bone health marker called C-telopeptide will be measured through blood tests.

  5. Step 5

    12-Month Final Assessment

    After completing the full 12 months of medication, you will attend a final assessment visit.

    You will complete all the same questionnaires and tests as at the 6-month visit (MENQOL, BPI, blood tests for hormones and bone markers).

    Side effects and medication adherence will be evaluated again.

    This visit marks the completion of your participation in the clinical trial.

Who can join the trial?

13 criteria

  • You must be postmenopausal (no menstrual periods for 12 months without another medical cause)
  • You must have one of the following:
    • Recent diagnosis (within the last 12 months) of ER+ DCIS (a type of pre-cancerous breast condition where cells in the milk ducts have abnormal growth) or diagnosis within 3 years of HRL (high-risk breast lesions like ADH, LCIS, or ALH which are abnormal cell growths that increase cancer risk)
    • At least 3% breast cancer risk at 5 years (or 5% risk at 10 years) according to specific risk calculation models
    • Known carrier of specific genetic variations (CHEK2 or ATM) within 5 years, or history of chest wall radiation before age 30
    • You must have had a negative gynecological examination within 6 months before signing the study consent
    • You must have good physical functioning ability (ECOG-PS 0-1, meaning you can perform daily activities with little or no assistance)
    • You must be able to swallow oral medications
    • You can participate if you had a prior or current cancer if it was diagnosed 3 or more years ago (except for breast and endometrial cancers)
    • You must be able to understand and willing to sign an informed consent document
    • You must have had a mammogram within 6 months before signing the study consent
    • You must have had a DEXA scan (bone density test) within 12 months before signing the study consent
    • You must have a life expectancy of at least 10 years
    • You must have normal liver function tests and blood cell count

Who cannot join the trial?

10 criteria

  • You cannot participate if you have a history of invasive breast cancer.
  • You cannot participate if you have had previous or current use of selective estrogen receptor modulators (like tamoxifen) or aromatase inhibitors (like exemestane) for longer than 1 month.
  • You cannot participate if you have severe heart disease that could prevent you from completing the trial.
  • You cannot participate if you have a history of deep vein thrombosis (blood clots in the deep veins, usually in the legs) or pulmonary embolism (blood clot in the lungs).
  • You cannot participate if you have severe osteoporosis (a condition that weakens bones, making them fragile and more likely to break).
  • You cannot participate if you have liver disease or high liver enzyme levels (more than 1.5 times the upper normal limit).
  • You cannot participate if you have kidney problems (creatinine levels greater than 2.0 mg/dL).
  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot participate if you have known allergies to the study medications (exemestane or tamoxifen).
  • You cannot participate if you have a history of other cancers in the past 5 years (except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix).
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Exemestane

    is a medication that belongs to a class of drugs called aromatase inhibitors. It works by lowering the amount of estrogen in the body, which can slow or stop the growth of certain types of breast cancer cells that need estrogen to grow. In this trial, a low dose of exemestane (called "babyexe") is being studied for its potential to reduce breast cancer risk in post-menopausal women who are at high risk.

  • Tamoxifen

    is a medication that blocks the effects of estrogen in the breast tissue. It is commonly used to treat breast cancer and to prevent breast cancer in women at high risk. In this trial, a low dose of tamoxifen (called "babytam") is being studied for its potential to reduce breast cancer risk in post-menopausal women who are at high risk.

What is already known about the treatment

  • Exemestane

    A hormonal therapy medication administered orally in tablet form that is FDA-approved for treating postmenopausal women with breast cancer. It is indicated for reducing the risk of breast cancer recurrence in postmenopausal women and treating advanced breast cancer after other treatments have failed. Exemestane works by inhibiting the enzyme aromatase, which is responsible for producing estrogen, thereby decreasing estrogen levels in the body that can stimulate cancer cell growth. This medication belongs to the class of drugs called aromatase inhibitors, which are commonly used in hormone-dependent breast cancer treatment.

  • Tamoxifen

    An oral medication taken as a tablet that is widely established in medical literature as a standard treatment for hormone receptor-positive breast cancer. It is indicated for breast cancer treatment in both pre- and postmenopausal women and for reducing breast cancer risk in high-risk individuals. Tamoxifen works by selectively binding to estrogen receptors in breast tissue, blocking estrogen from attaching to these receptors and preventing estrogen-stimulated tumor growth. This medication belongs to the selective estrogen receptor modulators (SERMs) class, which act differently on various estrogen-responsive tissues in the body.

Investigated diseases

Breast cancer is a malignant tumor that develops from the cells of the breast. It begins when breast cells start to grow uncontrollably, often forming a mass or lump that can be felt through the skin or detected on imaging tests. The disease typically progresses from localized cancer, where abnormal cells remain within the breast, to potentially more advanced stages where cancer cells may invade surrounding tissues or spread (metastasize) to other parts of the body through the bloodstream or lymphatic system. Breast cancer can affect various parts of the breast including ducts, lobules, and in some cases, the connective tissue. It may cause symptoms like breast lumps, skin changes, nipple discharge, or pain, though early-stage breast cancer often produces no noticeable symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520004-26-00Protocol codeBabyTEARSEstimated enrolment165 patientsSponsorEnte Ospedaliero Ospedali Galliera Di Genova

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.