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Study on Adding Elacestrant to Olaparib for Patients with HR-Positive, HER2-Negative Advanced Breast Cancer with gBRCA1/2 Mutations

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What is this trial about?

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

This clinical trial is focused on studying a type of breast cancer known as hormone receptor (HR)-positive, HER2-negative breast cancer that has either spread to nearby tissues or other parts of the body. This specific type of breast cancer also involves genetic changes called gBRCA1/2 mutations. The study is testing a new treatment approach by adding a medication called elacestrant to the standard treatment with another medication called olaparib. Elacestrant is a type of drug known as a selective estrogen receptor degrader (SERD), which works by targeting and breaking down estrogen receptors that help some breast cancers grow. Olaparib is a PARP inhibitor, which helps prevent cancer cells from repairing themselves, leading to their death.

The purpose of this study is to see if adding elacestrant to olaparib can improve the time patients live without their cancer getting worse, compared to using olaparib alone. Participants in the study will be randomly assigned to receive either the combination of elacestrant and olaparib or olaparib with a placebo. The study will last for up to 48 weeks, during which participants will take the medications in the form of film-coated tablets by mouth. Regular check-ups and assessments will be conducted to monitor the participants' health and the effects of the treatment.

This trial aims to provide valuable information on whether the combination of these medications can offer better outcomes for patients with this specific type of breast cancer. The study will also look at other factors, such as the overall survival of participants, the quality of life related to breast cancer, and any side effects experienced during the treatment. The results of this study could potentially lead to new treatment options for patients with HR-positive, HER2-negative breast cancer with gBRCA1/2 mutations.

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
Joining the study
Upon joining the study, the patient must provide written informed consent. This includes agreeing to attend scheduled visits, undergo treatment, and participate in follow-up activities.
A negative pregnancy test is required for female patients of childbearing potential within 72 hours before starting treatment. Male patients must agree to use contraception during the study and for at least 120 days after the last dose of elacestrant.
Step 2
Treatment initiation
The patient will begin treatment with olaparib and elacestrant. Olaparib is administered as Lynparza 150 mg film-coated tablets taken orally. Elacestrant is also administered orally in the form of film-coated tablets.
The specific dosage and frequency of administration will be determined by the study protocol and the patient's condition.
Step 3
Monitoring and assessments
Throughout the study, the patient's health and response to treatment will be monitored. This includes regular assessments to evaluate the progression of the disease and any side effects experienced.
The primary goal is to assess progression-free survival (PFS), which is the time from the start of treatment until the disease progresses or the patient passes away.
Step 4
Treatment adjustments
If necessary, adjustments to the treatment plan may be made based on the patient's response and any side effects. This could include dose reductions, delays, or interruptions.
The study will also track the time to treatment failure (TTF), overall survival (OS), and quality of life specific to breast cancer.
Step 5
Completion of study
The study is expected to continue until December 15, 2028. Upon completion, the patient's participation will end, and final assessments will be conducted.
Patients who are still under treatment or have not experienced disease progression at the end of the study will be noted at the date of last contact.

Who can join the trial?

11 criteria

Patients must provide written informed consent before starting any specific procedures related to the study. This means they agree to participate and understand what the study involves.
Patients should have a life expectancy of more than 6 months.
Female patients who can have children must have a negative pregnancy test within 72 hours before starting treatment. They must use highly effective non-hormonal birth control methods. Male patients must avoid heterosexual intercourse or use a condom during the study and for at least 120 days after the last dose of the study drug. They should also avoid donating sperm.
Both female and male patients can participate.
Patients must be at least 18 years old when they join the study.
Patients must have breast cancer that is locally advanced or has spread to other parts of the body. The cancer must be **hormone receptor (HR)-positive**, meaning it grows in response to hormones, and **HER2-negative**, meaning it does not have high levels of a protein called HER2.
Patients must have specific genetic changes called **gBRCA1/2 mutations**, which are detected through local testing.
Patients must be willing and able to provide a sample of their tumor tissue, which is preserved in a special way called **formalin fixed paraffin embedded (FFPE)**.
Patients must be suitable for a standard treatment called a **PARP inhibitor** and plan to be treated with a drug called olaparib.
Patients must have an **ECOG performance status** of 0 to 2, which is a scale used to assess how well they can perform daily activities. A score of 0 means fully active, while 2 means they are up and about more than half the day.
Any side effects from previous cancer treatments must be resolved to a mild level, except for hair loss or other effects that are not considered a safety risk.

Who cannot join the trial?

7 criteria

Patients who do not have **hormone receptor (HR)-positive** breast cancer. This means the cancer does not grow in response to hormones like estrogen or progesterone.
Patients whose cancer is **HER2-positive**. HER2 is a protein that can promote the growth of cancer cells. In this study, the cancer should be HER2-negative.
Patients without **gBRCA1/2 mutations**. These are specific genetic changes that can increase the risk of breast cancer.
Patients who do not have **locally advanced** or **metastatic** breast cancer. Locally advanced means the cancer has spread to nearby areas, and metastatic means it has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not part of the vulnerable population selected for the study.

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Verified sites

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

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Goethe University Frankfurt
Frankfurt, Germany
Verified
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Essen, Germany

Trial locations

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Investigated drugs

Elacestrant
is an oral medication that works by targeting and degrading estrogen receptors. It is used in this trial to see if it can improve outcomes for patients with certain types of breast cancer when added to another treatment.
Olaparib
is a medication that helps to block the repair of damaged DNA in cancer cells, which can lead to their death. It is used in this trial as a standard treatment for patients with specific genetic mutations in breast cancer.

What is already known about the treatment

Elacestrant
Elacestrant is an oral medication administered in pill form, currently being studied in clinical trials for its potential use in treating certain types of breast cancer. It is specifically being evaluated for patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with specific genetic mutations. Elacestrant works by degrading estrogen receptors, which can help slow or stop the growth of cancer cells that rely on estrogen. It is classified as a selective estrogen receptor degrader (SERD).
Olaparib
Olaparib is an oral medication taken in tablet form, widely recognized in medical literature for its role in cancer treatment. It is used for patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with specific genetic mutations. Olaparib functions by inhibiting the enzyme PARP, which helps repair DNA damage in cells, thereby preventing cancer cells from repairing themselves and leading to their death. It is classified as a PARP inhibitor.

Investigated diseases

Breast Cancer, Hormone Receptor-Positive, HER2-Negative – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It is HER2-negative, indicating that the cancer cells do not have an excess of the HER2 protein on their surfaces. This form of breast cancer can be locally advanced, meaning it has spread beyond the breast to nearby tissues, or metastatic, indicating it has spread to other parts of the body. The progression of this cancer can vary, with some cases remaining stable for extended periods, while others may progress more rapidly. Genetic mutations such as gBRCA1/2 can influence the behavior and treatment response of the cancer. Understanding the specific characteristics of the cancer is crucial for determining the most effective treatment approach.