Study on Elacestrant and Triptorelin for Premenopausal Women with Early Luminal Breast Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for premenopausal women with early-stage luminal breast cancer. The treatment involves the use of a medication called Elacestrant, which is taken orally as a film-coated tablet. Elacestrant is a type of drug known as a selective estrogen receptor degrader (SERD), which works by targeting and breaking down estrogen receptors in cancer cells. The study will also explore the effects of combining Elacestrant with another medication called Triptorelin, which is administered as an injection. Triptorelin is used to lower hormone levels in the body, which may help in treating breast cancer.

The purpose of this study is to evaluate the biological activity of Elacestrant, with or without the addition of Triptorelin, in women who have estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that can be surgically removed. The study will look at how these treatments affect the estrogen receptor pathway and the proliferation of cancer cells, as measured by a marker called Ki67. Participants will be randomly assigned to receive either Elacestrant alone or in combination with Triptorelin, and the effects will be monitored over a short period before surgery.

Throughout the study, participants will undergo various assessments to measure changes in cancer cell activity and hormone levels. The trial aims to provide insights into how these treatments can impact the growth of breast cancer cells and potentially improve outcomes for patients. The study is designed to be open-label, meaning both the participants and researchers will know which treatment is being administered. This trial is part of ongoing research to find effective treatments for breast cancer and to understand the role of hormone pathways in cancer progression.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent. This is a document that confirms your understanding and agreement to participate in the trial.

You will undergo a series of initial assessments to confirm your eligibility. These assessments include checking your health status, reviewing your medical history, and ensuring you meet specific criteria such as age and health condition.

2 initial assessments

You will have a blood test to check your overall health, including your blood cell counts and organ function.

A sample of your tumor tissue will be collected for analysis. This is to ensure the quality and suitability of the tissue for the study.

3 treatment phase

You will be randomly assigned to receive either elacestrant alone or elacestrant with triptorelin. Elacestrant is taken orally as a 400 mg film-coated tablet.

Triptorelin is administered as a solution for injection or infusion. The frequency and duration of administration will be explained to you by the study team.

The treatment phase is designed to evaluate the effect of the medication on your breast cancer.

4 monitoring and follow-up

Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes blood tests, imaging studies, and other necessary evaluations.

You will be asked to report any side effects or changes in your health to the study team.

5 end of treatment

At the end of the treatment phase, you will undergo a final set of assessments to evaluate the impact of the treatment on your cancer.

You will be provided with information on any further steps or follow-up care needed after the trial concludes.

Who Can Join the Study?

Must provide a signed informed consent before any trial-specific procedures.
Must have a Ki67 expression between 10% and 35%. Ki67 is a protein that helps to understand how fast cancer cells are growing.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work.
Breast cancer must be eligible for primary surgery.
Must provide a pre-treatment tumor tissue sample for analysis. This sample should be of good quality and will be checked before starting the trial.
Must have adequate blood and organ function, including:
- Enough neutrophils (a type of white blood cell) and platelets (cells that help with blood clotting).
- Hemoglobin levels of at least 9.0 g/dL without needing transfusions.
- Normal kidney function as shown by certain blood tests.
- Normal liver function tests.
- Normal levels of potassium, calcium, and sodium in the blood.
Must be a female patient at least 35 years old at the time of signing the consent.
Must be willing and able to attend scheduled visits, follow treatment plans, and undergo tests and procedures required by the trial.
If capable of becoming pregnant, must have a negative pregnancy test within 7 days before starting the trial.
Must agree not to donate or retrieve eggs for personal use during the study and for at least 120 days after the last dose of the study drug.
If capable of becoming pregnant, must agree to use highly effective contraception methods during the trial and for a period after stopping the treatment. Acceptable methods include:
- Total abstinence (no sexual activity).
- Non-hormonal intrauterine device (IUD).
Must be able to swallow oral medication.
Must be premenopausal, meaning having regular menstrual periods or certain hormone levels indicating premenopausal status. Patients who have had both ovaries removed are not eligible.
Must have a confirmed diagnosis of non-metastatic primary invasive breast cancer that is untreated and recently diagnosed, with specific characteristics:
- Stage I to IIB operable breast cancer.
- No distant metastasis (cancer spread to other parts of the body).
- At least one measurable lesion of 10 mm or larger.
If there are multiple tumors, the largest must be at least 10 mm and will be the focus for evaluations.
Tumor must be ER-positive (estrogen receptor-positive) with more than 10% of cells showing this characteristic and HER2-negative (a protein that can affect the growth of cancer cells).

Who Cannot Join the Study?

Patients who are not premenopausal women with early luminal breast cancer cannot participate. Premenopausal means women who have not yet gone through menopause.
Patients who are not female cannot participate.
Patients who are male cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study but is not specified here.
Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Icealkiy Ctqevx Dcwmhemflmrailcpp	L'hospitalet De Llobregat	Spain
Hfauexrs Upixibjoxfhvx Dj Brfoklg	Badajoz	Spain
Hzrlfykv Vugl dmsjxtmi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	31.08.2023

Trial locations

Investigated drugs:

Elacestrant is a medication being studied for its potential to treat breast cancer. It works by blocking the effects of estrogen, a hormone that can help some breast cancer cells grow. By interfering with this process, elacestrant may help slow down or stop the growth of cancer cells in patients with certain types of breast cancer.

Triptorelin is a therapy used to lower the levels of certain hormones in the body. In this trial, it is being used to help reduce the production of estrogen in premenopausal women. By doing so, it may enhance the effectiveness of other treatments that target estrogen receptors in breast cancer cells, potentially improving outcomes for patients with this type of cancer.

Investigated diseases:

Hormone receptor positive breast cancer

Early Luminal Breast Cancer – Early luminal breast cancer is a type of breast cancer characterized by the presence of hormone receptors, specifically estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-). It typically occurs in the milk-producing glands or ducts of the breast. The disease progresses as cancer cells grow and divide, potentially spreading to nearby tissues. In its early stages, it may not cause noticeable symptoms, but as it advances, it can lead to changes in breast shape, size, or appearance. The progression of this cancer is influenced by hormonal factors, and it may respond to hormonal changes in the body. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2023-503373-37-01

Protocol code:

SOLTI-2104

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Elacestrant and Triptorelin for Premenopausal Women with Early Luminal Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?