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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Ente Ospedaliero Ospedali Galliera Di Genova	Genoa	Italy
Champalimaud Clinical Centre	Lisbon	Portugal

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.06.2025
Portugal	Not yet recruiting	01.06.2025

Trial locations

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.

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 ID:

2024-520004-26-00

Protocol code:

BabyTEARS

NCT ID:

NCT06364267

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?