This clinical trial is focused on studying a type of breast cancer known as ER+/HER2- early breast cancer. This type of cancer is characterized by the presence of estrogen receptors (ER+) and the absence of human epidermal growth factor receptor 2 (HER2-). The study aims to evaluate the effectiveness and safety of a new treatment called Camizestrant, also known by its code name AZD9833. Camizestrant is a next-generation oral medication that works by degrading estrogen receptors, which are proteins that can promote the growth of breast cancer cells. The study will compare Camizestrant to standard endocrine therapies, which include medications like aromatase inhibitors and tamoxifen.
The purpose of this study is to determine if extended therapy with Camizestrant is more effective than standard treatments in preventing the recurrence of breast cancer. Participants in the study will have already completed at least two years of standard adjuvant endocrine-based therapy without any recurrence of the disease. The study will involve taking the medication for a period of up to 60 months, during which the safety and effectiveness of the treatment will be closely monitored. Some participants will receive Camizestrant, while others will receive standard treatments or a placebo.
Throughout the study, various aspects of the participants’ health will be assessed, including their overall survival and any side effects they may experience. The study will also look at how the treatment affects the quality of life, focusing on symptoms such as joint pain, hot flashes, and vaginal dryness. The goal is to provide valuable information on whether Camizestrant can offer a better option for patients with this type of breast cancer, potentially reducing the risk of the cancer returning after initial treatment.
1joining the study
Upon joining the study, you will be informed about the trial’s purpose, procedures, and your role. You will be asked to provide consent to participate.
You will undergo initial assessments to confirm eligibility, including a review of your medical history and current health status.
2treatment assignment
You will be randomly assigned to receive either the new treatment, camizestrant, or a standard endocrine therapy. This process is random to ensure fairness and accuracy in the study results.
3medication administration
If assigned to camizestrant, you will take it orally as a tablet. The dosage and frequency will be explained to you by the study team.
If assigned to standard therapy, you may receive one of the following medications: exemestane, letrozole, anastrozole, or tamoxifen citrate. These are also taken orally, and the specific dosage and frequency will be provided.
4regular check-ups
You will have regular appointments with the study team to monitor your health and the effects of the treatment. These may include physical exams, blood tests, and other assessments.
You will be asked about any side effects or changes in your health. It is important to report these accurately to ensure your safety and the study’s success.
5ongoing monitoring
Throughout the study, your progress will be closely monitored. This includes tracking your response to the treatment and any changes in your condition.
You may be asked to complete questionnaires about your quality of life and any symptoms you experience.
6completion of the study
At the end of the study period, you will have a final assessment to evaluate the overall impact of the treatment.
The study team will discuss the results with you and provide guidance on any next steps for your care.
Who Can Join the Study?
Both women and men can participate.
Participants must be 18 years or older at the time of screening.
Must have a diagnosis of ER+/HER2- early-stage breast cancer that has been surgically removed and is at high or intermediate risk of coming back.
Must have completed the necessary local treatment for the primary breast tumor, which may include surgery and possibly radiotherapy, with or without chemotherapy given before or after surgery.
Must have completed at least 2 years but no more than 5 years and 3 months of hormone therapy after surgery, with or without a type of drug called a CDK4/6 inhibitor.
Must have an ECOG performance status of 0 or 1, which means the participant is fully active or has some symptoms but does not need bed rest during the day.
Must have adequate organ and bone marrow function, meaning the organs and bone marrow are working well enough to participate in the study.
Who Cannot Join the Study?
Patients who have a different type of breast cancer than ER+/HER2- Early Breast Cancer cannot participate. This type of cancer is defined by specific characteristics of the cancer cells.
Patients who are not within the specified age range for the study cannot participate. The study is looking for participants in certain age groups.
Patients who are not part of the specified clinical trial groups cannot participate. These groups are defined by certain health conditions or characteristics.
Patients who are not female cannot participate, as the study is focused on female subjects.
Patients who are considered part of a vulnerable population cannot participate. This includes individuals who may have additional health or social challenges.
Camizestrant is a new type of medication taken by mouth that is designed to target and break down estrogen receptors in the body. Estrogen receptors can help some breast cancers grow, so by breaking them down, camizestrant aims to prevent the cancer from coming back. This medication is being tested to see if it works better than the usual treatments for breast cancer that rely on blocking estrogen.
Aromatase Inhibitors are a group of medications that help lower the amount of estrogen in the body. Estrogen can help some breast cancers grow, so by reducing its levels, these medications aim to prevent the cancer from returning. They are commonly used as a standard treatment for certain types of breast cancer.
Tamoxifen is a medication that blocks estrogen from reaching cancer cells. Estrogen can help some breast cancers grow, so by blocking it, tamoxifen aims to stop the cancer from coming back. It is a well-known treatment used for certain types of breast cancer.
Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer – This type of breast cancer is characterized by the presence of estrogen receptors and the absence of excess HER2 protein on the surface of cancer cells. It typically begins in the breast tissue and is detected at an early stage, meaning it has not spread extensively. The cancer cells grow in response to estrogen, which can fuel their proliferation. Over time, if untreated, the cancer may progress by invading nearby tissues or spreading to other parts of the body. The progression can vary, with some cases remaining localized for extended periods while others may advance more rapidly. The disease is often monitored for changes in size or spread to ensure timely management.
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