Advanced breast cancer, also called stage 4 breast cancer, is when the cancer has spread beyond the breast and nearby lymph nodes to other parts of the body. This can include areas like the lungs, liver, brain, or bones. When cancer spreads like this, it’s called metastasis. Even though the cancer is found in other parts of the body, it is still considered breast cancer and is treated as such.”
In 2021, the incidence rate of metastatic breast cancer in women was 7.9 per 100,000, according to the CDC. Nearly 30% of women who are diagnosed with early-stage breast cancer eventually develop metastatic disease. Because male breast cancer is rare, it’s not clear how often it spreads to other parts of the body. However, men can also be diagnosed with metastatic breast cancer.
According to the American Cancer Society, the outlook for stage 4 breast cancer has traditionally been challenging, but more people are living longer after diagnosis. This is partly due to improvements in treatment.
The process of cancer spreading to other parts of the body is called metastasis. This happens when cancer cells break away from the original tumor, such as in the breast, and move to other areas of the body. The cancer cells can travel through the bloodstream or the lymphatic system to reach places like the bones, liver, lungs, or brain.
Advanced hormone receptor-positive breast cancer means the cancer has spread to other parts of the body and the cancer cells have tested positive for hormone receptors—either estrogen receptors (ER), progesterone receptors (PR), or both.
HER2-negative breast cancer means that the cancer cells do not have high levels of a protein called human epidermal growth factor receptor 2 (HER2). HER2 is found on the surface of breast cells and helps control their growth and division.
Although stage 4 breast cancer cannot be cured, it can be treated. Thanks to advances in research and the development of new medications, many people are living longer by managing the disease like a long-term condition, with a focus on maintaining quality of life. With good care and support, advanced breast cancer may respond well to various treatments that can help extend life for several years.”
The use of CDK4/6 inhibitors combined with endocrine therapy in this study will not cure your advanced breast cancer. However, adding CDK4/6 inhibitors to endocrine therapy has been shown to help patients with hormone receptor-positive (HR+) advanced breast cancer live longer without the disease getting worse, and it can also improve overall survival when used as a first or second treatment option.
Line of therapy is a way to number each round of cancer treatment a patient receives, showing the order in which treatments are given. First-line therapy is the initial treatment most doctors choose for patients who haven’t been treated before because it is usually effective and has fewer risks. If the first treatment doesn’t work, doctors will try second-line therapy, which is the next option.
Currently, all patients start with the same dose of CDK4/6 inhibitors, which are taken by mouth. However, older breast cancer patients have been shown to have a higher risk of side effects. Because of this, doctors often lower the starting dose for older patients to reduce side effects and help them stay on treatment longer. In this study, the starting dose of CDK4/6 inhibitors will be adjusted based on each participant’s health, which will be assessed through a questionnaire. The idea is that tailoring the dose to a patient’s overall health could reduce side effects and allow patients to stay on treatment for a longer time.
As a participant in this study, you will complete the Comprehensive Geriatric Assessment questionnaire. Your doctor will use your answers to better understand your overall health. This can help your doctor decide if you need any extra care or support to feel better during your treatment. By taking part in this study, you will also help researchers learn more about how CDK4/6 inhibitors work in breast cancer patients over 70 years old. Your participation might help future older patients receive the right dose of treatment.
Older cancer patients are often not included enough in important drug studies, including those for CDK4/6 inhibitors. We know that older patients are more likely to have side effects from these medicines. Because of this, doctors sometimes start older patients on a lower dose, but there isn’t strong proof that this is the best approach. The IMPORTANT trial wants to find out if starting with a lower dose might actually help patients stay on treatment longer with fewer side effects. In this study, a special health questionnaire called the Comprehensive Geriatric Assessment will be used to help doctors adjust the treatment for older patients with advanced breast cancer. The goal is to reduce side effects and help patients feel better during treatment.
The IMPORTANT trial will study whether a self-filled questionnaire which looks at different parts of a person’s physical and mental health, can help decide the best starting dose of CDK4/6 inhibitors. In this study, the starting dose will be adjusted based on each participant’s health, as shown by their answers to the CGA questionnaire. The idea is that by carefully looking at a patient’s health, doctors can choose a dose that causes fewer side effects and allows patients to stay on treatment longer.
The IMPORTANT trial includes older breast cancer patients (70 years and older, both men and women) who have advanced hormone receptor-positive breast cancer. These patients cannot be cured with current treatments and have not yet received any treatment for their advanced cancer.
CDK4/6 inhibitors are a type of medicine used to treat certain breast cancers that are hormone receptor-positive and HER2-negative. These medicines come as pills and work by stopping cancer cells from dividing and growing. They do this by targeting specific proteins called cyclin-dependent kinases 4 and 6, or CDK4/6 for short. Because they focus on these specific proteins, they are called targeted therapies. The IMPORTANT trial includes three types of CDK4/6 inhibitors: Palbociclib, Ribociclib, and Abemaciclib.
CDK4/6 inhibitors are not chemotherapy. They are targeted therapy.
The only extra thing you’ll need to do for this study, beyond your usual care, is to fill out some questionnaires about your health and the care you’re receiving. These questionnaires take about 30 to 45 minutes to complete. You will fill them out every three months during the first year, and then every six months for the second year.
You can find information about the trial in your own language in the ‘information and informed consent form for trial subjects’ that you will receive before you decide to join the study.
Participation is voluntary.
There is a risk for side effects with CDK 4/6-inhibitors and endocrine therapy. You can find more information about possible side effects of CDK4/6 inhibitors and endocrine therapy in the ‘information and informed consent form for trial subjects’ that you will get before joining the study. The trial doctor or staff will also review this list with you. Besides the side effects listed, there is always a chance of experiencing side effects that are not known yet.
When you take part in the IMPORTANT trial, you will receive the same treatment that is recommended by medical guidelines. The only extra thing you’ll need to do for the study is to fill out some questionnaires about your health and the care you are getting while in the trial.
So far, starting with a lower dose of CDK4/6 inhibitors hasn’t been shown to be less effective than the full dose in patients over 70 years old. This study is based on the idea that a lower starting dose might be better because it could help patients stay on treatment longer without side effects. The study will test this idea. However, it is still possible that the lower dose may not work quite as well as the full dose. During your treatment, your doctor will do tests to see how well the treatment is working and decide the best way to continue.
You won’t have to pay anything to take part in the trial. The treatments used in the study are standard care and are covered by the national healthcare program.
By taking part in this study, you will help future older patients get the right starting dose of CDK4/6 inhibitors. Your participation will also help researchers learn more about how these medicines work in breast cancer patients over 70 years old.
You cannot take part in the IMPORTANT trial if you are already participating in another treatment trial.
You and your family can ask questions about the trial and talk with the investigator or your doctor. You will also get a document called the ‘information and informed consent form for trial subjects’ before you decide to join the trial, which has important details. You can find more information about this study online at https://clinicaltrials.gov/study/NCT06044623
Whether you choose to join the study or not will not change the treatment you get.
You can stop taking part in the study at any time. Please tell the investigator right away if you decide to stop, but you don’t have to explain why. You will continue to get the best treatment and follow-up care for your illness, as you and your doctor decide.
If you take part in the study, the risks will be the same as with the usual treatment for your disease using CDK4/6 inhibitors and endocrine therapy.
