Evaluating Elacestrant alone or with leuprorelin in premenopausal women with early-stage hormone receptor positive breast cancer before surgery

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What is this study about?

This study focuses on breast cancer, specifically in premenopausal women with ER-positive/HER2-negative stage I-II breast cancer. The study evaluates two treatment approaches: one using elacestrant alone, and another combining elacestrant with leuprorelin, which is a hormone therapy that suppresses ovarian function.

The main purpose is to determine if using elacestrant by itself for 4 weeks before surgery is as effective as using it in combination with leuprorelin. The effectiveness will be measured by examining changes in a protein called Ki67, which indicates how fast cancer cells are growing. During the study, patients will receive either elacestrant tablets alone or elacestrant tablets plus leuprorelin injections.

Throughout the treatment period, patients will undergo various assessments including blood tests and magnetic resonance imaging (MRI) scans. The study will monitor how well patients respond to treatment and track any side effects they may experience. After the treatment period, patients will proceed with their planned breast surgery, and follow-up evaluations will continue for up to 6 months after surgery.

1 Initial assessment

The trial begins with confirmation of your eligibility through blood tests and organ function assessment within 7 days before starting treatment

A pregnancy test will be performed if applicable (must be completed within 72 hours before first dose)

Your current breast cancer tissue sample will be evaluated to confirm ER-positive and HER2-negative status

2 Treatment assignment

You will be assigned to one of two treatment groups:

Group 1: Elacestrant tablets alone

Group 2: Elacestrant tablets plus Leuprorelin injection

3 4-week treatment period

Duration of treatment: 28 days

You will take Elacestrant film-coated tablets daily

If assigned to group 2, you will also receive one Leuprorelin injection (Zeulide 3.75 mg) into the muscle

4 Monitoring visits

Day 14: Blood sample collection to measure hormone levels

Day 28: Final blood sample collection before surgery

MRI scan to assess response to treatment

5 Surgery and follow-up

Breast surgery will be performed after completing the 4-week treatment

One-month post-surgery: Blood test to check hormone levels

Regular check-ups for 6 months after surgery to monitor for any side effects

Who Can Join the Study?

Must be female aged 18 or older
Must have normal organ function including:
– Adequate blood cell counts
– Proper kidney function
– Normal liver function tests
– Normal blood electrolyte levels (potassium, sodium, calcium, magnesium, phosphorus)
Must be premenopausal (having regular menstrual periods in the last 6 months)
Must have breast cancer that is:
– Early stage (Stage I or II)
– Hormone receptor positive
– HER2 negative
– With specific growth rate markers (Ki67 between 10% and 30%)
Must be eligible for breast surgery
Must have a tissue sample available from previous biopsy
Must have good physical fitness level (ECOG status 0-1, meaning able to perform daily activities)
If able to become pregnant, must:
– Have a negative pregnancy test within 72 hours before starting treatment
– Agree to use effective non-hormonal birth control during treatment and for 120 days after
Must be willing to:
– Sign informed consent form
– Follow study requirements
– Attend scheduled visits
– Complete required tests
Must be enrolled in a Social Security System or equivalent

Who Cannot Join the Study?

Patient is not female
Patient is not between 18 and 65 years old
Patient does not have stage I or II breast cancer (early stages of breast cancer confined to breast area)
Patient does not have ER-positive/HER2-negative breast cancer (cancer that grows in response to estrogen but not to HER2 protein)
Patient is not premenopausal (still having regular menstrual periods)
Patient has received previous treatment for breast cancer
Patient has cancer that has spread to other parts of the body
Patient is pregnant or breastfeeding
Patient has severe medical conditions that could interfere with study treatment
Patient is participating in another clinical trial
Patient has known allergies to study medications
Patient has conditions that would make it difficult to follow study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centre Jean Perrin	Clermont Ferrand	France

Other Sites

Site Name	City	Country	Status
Cmhjnl Lfnm Bdbfod	Lyon	France
Ikdilyrf Pwjaodoknorwowd Cehfar Cfaybj	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Elacestrant is an oral medication used to treat certain types of breast cancer. It works by blocking estrogen receptors, which helps slow down or stop the growth of breast cancer cells that depend on estrogen to grow. This medication is being studied as a new treatment option for patients with hormone receptor-positive breast cancer.

Leuprorelin (also known as leuprolide) is a hormone therapy medication that suppresses ovarian function. It works by reducing the production of estrogen in the body. This medication is commonly used in breast cancer treatment to stop the ovaries from producing hormones that might stimulate cancer growth in premenopausal women.

Investigated diseases:

Breast cancer

Breast Cancer – A disease that begins when cells in the breast start to grow out of control and form abnormal tissue. It typically starts in either the ducts that carry milk to the nipple or the glands that make breast milk. The cancer cells can grow into surrounding breast tissue and may eventually spread to lymph nodes. Breast cancer most commonly presents as a painless lump or thickening in the breast tissue. The disease can affect both women and men, though it’s much more common in women. In early stages, breast cancer may not cause noticeable symptoms.

Trial ID:

2024-520051-24-00

Protocol code:

CSET 2025/4053

Trial Phase:

Therapeutic exploratory (Phase II)

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Evaluating Elacestrant alone or with leuprorelin in premenopausal women with early-stage hormone receptor positive breast cancer before surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?