Study of Elacestrant for Patients with Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer Who Have Not Used CDK4/6 Inhibitors

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as metastatic breast cancer, which is a form of cancer that has spread beyond the breast to other parts of the body. The study is specifically looking at patients with estrogen receptor positive and HER2 negative breast cancer. These terms refer to specific characteristics of the cancer cells that can influence how the cancer behaves and responds to treatment. The treatment being tested in this study is a medication called elacestrant, which is taken in the form of film-coated tablets. Elacestrant is being evaluated for its effectiveness in patients who have previously received one or two hormonal therapies for their advanced or metastatic breast cancer but have not been treated with a type of medication known as CDK4/6 inhibitors.

The purpose of the study is to assess how well elacestrant works in controlling the cancer. Participants in the study will receive elacestrant as an oral medication, meaning it is taken by mouth. The study will monitor the participants over a period to see how the cancer responds to the treatment. This includes looking at how long the cancer stays under control and whether it shrinks or disappears. The study will also track the overall survival of participants, which refers to the length of time participants live after starting the treatment.

Throughout the study, participants will be regularly assessed to check the progress of their cancer and any side effects they may experience. The study aims to provide valuable information on the potential benefits of elacestrant for treating this specific type of breast cancer. By participating in this study, researchers hope to gather data that could lead to improved treatment options for patients with metastatic breast cancer in the future.

1 joining the study

Upon joining the study, the patient must sign an informed consent form. This is a document that confirms the patient’s understanding and agreement to participate in the study.

The patient must meet specific criteria, such as having a confirmed diagnosis of estrogen receptor-positive, HER2-negative metastatic breast cancer and having received 1 or 2 prior hormonal therapies in the metastatic setting.

2 medication administration

The patient will receive elacestrant, which is available in two dosages: ORSERDU 345 mg and ORSERDU 86 mg film-coated tablets.

The medication is taken orally. The specific dosage and frequency will be determined by the study protocol and the patient’s condition.

3 treatment duration

The treatment will continue until there is evidence of disease progression or unacceptable side effects occur.

The study aims to evaluate the effectiveness of elacestrant over a period that may extend until the estimated end date of May 31, 2027.

4 monitoring and assessments

Regular assessments will be conducted to monitor the patient’s response to the treatment. This includes imaging tests to check for disease progression.

The primary goal is to measure Progression Free Survival (PFS), which is the time from the first dose to the first sign of disease progression or death.

5 evaluation of outcomes

Secondary outcomes include the Objective Response Rate (ORR), which measures the proportion of patients with a significant reduction in tumor size.

Other outcomes include the Duration of Response (DoR), Clinical Benefit Rate (CBR), and Overall Survival (OS).

Who Can Join the Study?

The patient must have signed a form agreeing to participate in the study before any study-related activities begin.
The patient can have a return of the disease while on hormone therapy after the first two years, or within 12 months after finishing hormone therapy. This is known as secondary-resistant breast cancer.
The patient must be a woman or man aged 18 years or older. Women can be either postmenopausal (no longer having periods) or premenopausal/perimenopausal (still having periods or in transition). Premenopausal or perimenopausal women and men must take a medication called an LHRH agonist before and during the study.
The patient must have a confirmed diagnosis of ER+/HER2– breast cancer. This means the cancer cells have certain characteristics related to hormone receptors.
The patient must have at least one measurable area of cancer, or a specific type of bone lesion, as determined by medical guidelines.
The patient must have a good level of daily functioning, as measured by the ECOG performance status of 0 or 1, which indicates they are fully active or have some symptoms but do not need to rest during the day.
The patient must have adequate bone marrow and organ function, as shown by specific blood test results.
The patient must be able and willing to follow the study’s requirements.
The patient must have received at least one, but no more than two, prior hormone therapies for advanced or metastatic cancer.
The patient must have shown disease progression, meaning the cancer has grown or spread, during or after the most recent therapy for advanced or metastatic cancer.

Who Cannot Join the Study?

Patients who have received more than 2 prior hormonal therapies for their cancer.
Patients who have previously been treated with a type of medication called CDK4/6 inhibitors. These are drugs used to stop cancer cells from growing.
Patients who do not have ER+ (estrogen receptor-positive) or HER2- (human epidermal growth factor receptor 2-negative) breast cancer. These terms describe specific characteristics of the cancer cells.
Patients who are not within the specified age range for the study.
Patients who are not able to provide informed consent or understand the study requirements.
Patients who have other medical conditions that might interfere with the study or make participation unsafe.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.

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
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Complex Oncological Center – Shumen EOOD	Shumen	Bulgaria
Complex Oncological Center Plovdiv EOOD	Plovdiv	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	07.12.2023
Romania	Not recruiting	07.12.2023

Trial locations

Investigated drugs:

Elacestrant

Elacestrant is a medication being studied for its effectiveness in treating advanced or metastatic breast cancer that is estrogen receptor-positive (ER+) and HER2-negative. This trial focuses on patients who have previously received one or two hormonal therapies for their metastatic breast cancer but have not been treated with CDK4/6 inhibitors. Elacestrant works by targeting and blocking the estrogen receptor, which can help slow down or stop the growth of cancer cells that rely on estrogen to grow.

Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is considered an advanced stage of breast cancer, often referred to as stage IV. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms can vary depending on where the cancer has spread, but may include bone pain, difficulty breathing, or neurological symptoms. The progression of metastatic breast cancer can be influenced by factors such as hormone receptor status and previous treatments. It is a chronic condition that requires ongoing management to control symptoms and slow the spread of the disease.

Trial ID:

2023-503214-68-00

Protocol code:

STML-ELA-0322

NCT ID:

NCT05596409

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Elacestrant for Patients with Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer Who Have Not Used CDK4/6 Inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?