Recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

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

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.

The research process

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

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

10 criteria

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 trial?

12 criteria

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

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Verified sites

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

Centr Georges Francois Leclerc
Verified
Dijon, France
Centre Francois Baclesse
Verified
Caen, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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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.

What is already known about the treatment

Elacestrant
An oral selective estrogen receptor degrader (SERD) medication used in clinical trials for treating hormone receptor-positive breast cancer. This drug works by binding to and degrading estrogen receptors, effectively blocking estrogen signaling that can promote cancer growth. Administered as oral tablets, Elacestrant represents a new generation of breast cancer treatments that may offer advantages over traditional injectable SERDs. The medication belongs to the class of endocrine therapy agents and is currently being studied in early-stage breast cancer patients, particularly focusing on its effectiveness in premenopausal women.
Leuprorelin
A synthetic hormone medication administered via injection that belongs to the class of gonadotropin-releasing hormone (GnRH) agonists, also known as luteinizing hormone-releasing hormone (LHRH) agonists. This medication works by suppressing ovarian function through reducing the production of estrogen in premenopausal women, making it valuable in hormone-sensitive breast cancer treatment. Leuprorelin acts by initially stimulating and then suppressing the pituitary gland's production of hormones that affect estrogen levels, effectively creating a temporary menopause-like state.

Investigated diseases

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.