Have you been diagnosed with advanced breast cancer?
What is ER+/HER2- breast cancer?
Knowing what type of breast cancer you have will help doctors determine the best treatment.
Breast cancer is a type of cancer that develops in women and men from breast tissue, when the cells grow and divide out of control. A breast is made up of three main parts: lobules, ducts, and connective tissue. Most of the breast cancers begin from the lobules (milk-producing gland) or ducts (tubes that carry milk to the nipple). This type of cancer is called adenocarcinoma.
An estrogen-receptor-positive ER+ cancer has receptors for estrogen at the surface of the tumor cells. This suggests the cancer cells, like normal breast cells, may receive signals from estrogen that could stimulate their growth. Breast cancer that does not contain high levels of HER 2 (human epidermal growth factor receptor 2) protein at the surface of the tumor cells are known as HER2-.
Some other definitions that could help you to better understand your disease:
Locoregional recurrent breast cancer:
The development of new tumor in the breast/body part previously affected by cancer, such as chest wall and/or axillary and clavicular lymph node, is called a locoregional recurrence.
Metastatic breast cancer:
Metastases develop when cancer cells break away from body area or organ where they first formed and spread to a different part of the body. When this happens, cancer is then called a metastatic cancer.
Medicine that travels through the body, in the bloodstream, to find, damage or destroy cancer cells are called systemic treatment. It includes chemotherapy, immunotherapy, hormone therapy or targeted therapy.
Advanced breast cancer:
Advanced breast cancer corresponds to a breast cancer that is locoregional or metastatic.
Progression Free Survival:
Progression Free Survival (PFS) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression free survival is one way to see how well a new treatment works.
What is the AMEERA-5 study?
The AMEERA-5 study is an international clinical study sponsored by Sanofi to determine whether an investigational drug, given in combination with palbociclib, improves progression free survival (PFS) when compared with letrozole, in combination with palbociclib, in participants with ER+/HER2- advanced breast cancer. Researchers will evaluate the investigational drug's safety, whether it has a beneficial effect and if there are side effects.
Eligible and consenting participants to the AMEERA-5 study will be assigned at random (like flipping a coin) to either:
What is the
What is the investigational drug?
The investigational drug is a new medicine that is being developed but that is not yet approved by health authorities. The investigational drug belongs to a class of hormonal drugs called “selective estrogen receptor degrader (SERD)”. The investigational drug may act in the body by reducing the quantity of estrogen that feed into breast cancer cells, causing the tumor to shrink and leading to improvement of the disease.
The investigational drug comes in tablets and is taken by mouth with or without food, approximately at the same time each day.
What can you expect if you participate in the AMEERA-5 study?
The AMEERA-5 team is looking for women or men who are at least 18 years old and who have been diagnosed with estrogen receptor ER+/HER2- breast cancer.
If you qualify, you may take part in the study. You will be closely followed-up by your physician to see if the investigational drug works and to make sure it is safe for you. During the study, feel free to discuss your research care with the study doctor or research staff members. Thanks to the information collected during a clinical research study, the investigational medicine may or may not be approved by health authorities. The information may also help for future studies or lead to the development of other new medicines.
IT IS IMPORTANT TO:
As a study participant, you will have the right to contact the study's Institutional Review Board (IRB) or Ethics Committee (EC) representatives regarding your rights as a research participant. You also have the right to stop taking the investigational drug and/or leave the study at any time.
The study will last approximately six years.
What is a clinical research study?
Before people can take a new medicine, studies have to show that this medicine is safe and effective. These studies are called clinical research studies. These clinical research studies are a mandatory part of the process that leads to health authority review and approval, which is required before a drug can be marketed.
Clinical research studies are conducted to test if an experimental medicine works and is safe to use. When a new medicine or therapy is being developed, we may not know whether it will be helpful, harmful, or not different than other medicines already prescribed. Researchers therefore need to show that the medicine is safe and effective. To do that, they measure certain outcomes in the participants.
Each person taking part in the study must voluntarily agree to be in the study and follow the instructions of the study doctor. They are free to leave the study at any time.
A clinical trial is overseen by an independent committee, called an IRB. People on this committee are usually doctors, scientists, and patient advocates. This committee ensures the clinical trial is conducted ethically, and that it is designed to protect the rights and welfare of study participants.
What is a placebo?
A placebo may look like the medicine being tested, but it has no medical effect. Placebos are sometimes used to help tell the difference between the investigational drug being studied and no treatment.
During the consent process, you will be told whether the study involves the use of placebo, and what your chances are of receiving it. You will also be informed of any potential risks if you receive placebo.
National Breast Cancer Foundation, Inc. Learn About Breast Cancer, updated 15 April 2020. Accessed at https://www.nationalbreastcancer.org/about-breast-cancer on 01 July 2021.
National Cancer Institute. Dictionary of Cancer Terms, updated 25 August 2020. Access at https://www.nationalbreastcancer.org/about-breast-cancer on 26 July 2021.
MAT-US-2105468 V3.0 Expiration Date: 07/20/23