This clinical trial is focused on studying the treatment of breast cancer, specifically in patients who have a type of breast cancer known as ER+/HER2-. This means the cancer cells have receptors for estrogen but not for a protein called HER2. The study is investigating a medication called elacestrant, which is being compared to standard endocrine therapy. Endocrine therapy is a treatment that blocks or lowers the amount of hormones in the body to slow down or stop the growth of cancer. The purpose of the study is to see if elacestrant can delay the spread of cancer to other parts of the body or prevent death in patients who have a relapse detected by a test called ctDNA, which looks for cancer DNA in the blood.
Participants in the study will be randomly assigned to receive either elacestrant or one of the standard endocrine therapies, which include medications like tamoxifen, anastrozole, exemestane, and letrozole. Some patients may also receive additional treatments such as leuprorelin, goserelin, or triptorelin, which are used to lower hormone levels in the body. The study will last for a period of up to 104 weeks, during which the effects of the treatments will be monitored. The study aims to determine which treatment is more effective in preventing the cancer from spreading or causing death.
Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the treatment. These tests may include imaging scans like MRI or CT scans, which use magnetic fields or X-rays to create detailed pictures of the inside of the body. The study will also collect information on the safety of the treatments and how they affect the quality of life of the participants. The results of this study could help improve treatment options for patients with this type of breast cancer in the future.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a positive test for circulating tumor DNA (ctDNA) and a history of ER positive, HER2 negative breast cancer.
Participants must have completed certain prior treatments and be planning to continue with adjuvant endocrine therapy.
2randomization
Participants are randomly assigned to one of two groups: one receiving elacestrant and the other receiving standard endocrine therapy.
The goal is to compare the effectiveness of elacestrant in delaying distant metastasis or death.
3treatment phase
Participants in the elacestrant group take the medication orally. The dosage and frequency are determined by the study protocol.
Participants in the standard therapy group receive one of the following medications: tamoxifen, anastrozole, letrozole, exemestane, or elacestrant, depending on their specific treatment plan.
Additional medications such as leuprorelin, goserelin, or triptorelin may be administered via injection if required.
4monitoring and follow-up
Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.
This includes imaging tests and blood tests to track the presence of ctDNA and any signs of metastasis.
5completion of the study
The study is expected to continue until May 2032, with participants being followed up for outcomes such as distant metastasis-free survival and overall survival.
Participants’ experiences and outcomes are documented to evaluate the safety and effectiveness of the treatments.
Who Can Join the Study?
Patients must have breast cancer that is ER positive and HER2 negative. This means the cancer cells have certain characteristics: ER positive means at least 10% of the cells have estrogen receptors, and HER2 negative means the cells have a low score on specific tests.
Patients can be either female (both pre- and postmenopausal) or male.
Patients must be at least 18 years old.
Patients must have an elevated risk of recurrence after treatment for early breast cancer. This means they have certain stages of cancer or have completed specific chemotherapy treatments.
Patients must have received at least 4.5 years and up to 7 years of endocrine therapy (ET) and plan to continue it during the screening phase. Endocrine therapy is a treatment that blocks hormones that can help cancer grow.
Patients must have a ctDNA positive result according to a specific test. ctDNA is a type of DNA found in the blood that can indicate cancer.
Patients must be receiving adjuvant ET at the time of the ctDNA positive test. Adjuvant ET is additional hormone therapy given after the main treatment to lower the risk of cancer returning.
Patients must not have any locoregional or metastatic disease. This means the cancer has not spread to nearby areas or other parts of the body.
Patients must have an ECOG performance status of 0-1. This is a scale that measures how well patients can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Patients must have adequate organ function. This means their organs are working well enough to handle the treatment.
Women of childbearing potential must have a negative pregnancy test before starting the trial.
Patients must provide a tumor sample from a previous biopsy or surgery. This sample must meet certain size and cellularity requirements.
Patients must give written informed consent to participate, following specific guidelines and regulations.
Who Cannot Join the Study?
Patients who have a different type of cancer other than breast cancer.
Patients who are not experiencing a ctDNA-relapse. This means that there is no detectable cancer DNA in their blood after treatment.
Patients who are not diagnosed with ER+/HER2- breast cancer. This refers to a specific type of breast cancer that is positive for estrogen receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-).
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are considered part of a vulnerable population, which may include groups like pregnant women, children, or those unable to give consent.
Elacestrant is a medication being studied for its potential to treat breast cancer that is positive for estrogen receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-). This medication is being tested to see if it can delay the spread of cancer to other parts of the body or prevent death in patients who have experienced a relapse detected by circulating tumor DNA (ctDNA).
Standard Endocrine Therapy refers to the usual treatment given to patients with ER+ breast cancer. This therapy typically involves medications that block the effects of estrogen, a hormone that can promote the growth of breast cancer cells. The trial is comparing the effectiveness of elacestrant against these standard treatments to see which is more effective in delaying cancer progression or death.
Breast cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It is often classified by the presence of hormone receptors, such as estrogen receptor-positive (ER+) or human epidermal growth factor receptor 2-negative (HER2-), which can influence its behavior and response to treatment. Symptoms may include changes in breast shape, skin dimpling, or nipple discharge. Early detection through screening can improve outcomes by identifying the disease before it spreads.
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