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Study evaluating the omission of exemestane, letrozole, anastrozole, and tamoxifen in postmenopausal women with low-risk early breast cancer.

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on individuals with early Breast Cancer that has a specific type known as Luminal A. This means the cancer cells are Hormone Receptor Positive, meaning they rely on hormones like estrogen and progesterone to grow, and they are HER2-negative, which means they lack a specific protein that can promote cancer growth. The study is designed for patients who are postmenopausal and have a low risk of the cancer returning. The goal of the study is to determine if it is safe to skip Endocrine Therapy, which is a type of treatment that uses drugs to block hormones, in patients who have already had surgery and radiation.

In this trial, participants will be monitored to see how long they remain free from the cancer returning. The medications typically used in such treatments include Exemestane, Anastrozole, Letrozole, and Tamoxifen. These drugs are taken orally to prevent the cancer from growing back by interfering with the body's hormone levels. During the course of the study, researchers will observe the participants over several years to track their health and monitor for any signs of the disease returning in the breast or in other parts of the body.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry and treatment
After joining the study, the adjuvant radiotherapy (radiation therapy used to kill any remaining cancer cells) is received if breast-conserving surgery (surgery to remove the tumor while keeping the breast) was performed.
No endocrine therapy (hormone therapy used to prevent cancer from returning) is administered during this trial.
Step 2
Monitoring and follow-up
The progress is monitored to track the relapse-free interval, which is the time between the initial treatment and any sign of the cancer returning in the same breast, appearing in other parts of the body, or death caused by breast cancer.
Long-term monitoring is conducted to observe the occurrence of ipsilateral ductal carcinoma in situ (non-invasive cancer in the same breast), invasive contralateral breast cancer (invasive cancer in the opposite breast), and distant disease-free survival (the time during which the cancer does not spread to distant organs).
Health assessments are performed over 5, 8, and 10 years to track overall survival (the length of time a person remains alive) and to monitor for bone-related events, osteopenia/osteoporosis (conditions involving decreased bone density), dyslipidemia (unhealthy levels of fats in the blood), and cardiovascular events (such as heart attack or stroke).

Who can join the trial?

14 criteria

Female participants who are 60 years of age or older.
Women who are postmenopausal, meaning they no longer have menstrual periods, either because they had their ovaries removed or because they have not had a period for at least 12 months without using chemotherapy.
A willingness and ability to follow all study rules, including attending scheduled appointments, undergoing medical tests, and following the treatment plan.
A requirement to be part of a Social Security System or a similar government insurance program.
The ability to sign a written informed consent form, which is a document where you agree to participate in the study after understanding all the details.
A recent diagnosis of invasive breast cancer, which is cancer that has started to spread into the surrounding breast tissue.
The main tumor must be small, measuring 1 centimeter or less when looked at under a microscope.
No signs that the cancer has spread to the lymph nodes (small glands that part of the immune system) or to other parts of the body.
The other breast must show a BI-RADS 1 or 2 result on imaging, which means the imaging shows no signs of cancer in that breast.
Specific hormone and protein markers must be present: the cancer must be ER positive (responds to estrogen), PR positive (responds to progesterone), have a low Ki67 level (a protein that shows how fast cells are growing), and be HER2 negative (does not have too much of a specific growth protein).
The cancer cells must be a low histological grade, which means the cells look similar to normal cells and tend to grow more slowly.
The patient must have had surgery, such as a mastectomy (removal of the breast) or breast-conserving surgery (removing only the tumor), with clear margins, meaning no cancer cells were found at the very edge of the tissue removed.
If the patient had breast-conserving surgery, they must have received or be scheduled to receive adjuvant radiotherapy, which is radiation treatment used after surgery to kill any remaining cancer cells.
The patient must not require adjuvant chemotherapy, which is the use of drugs to kill cancer cells after the main treatment.

Who cannot join the trial?

15 criteria

You have received any neoadjuvant treatment, which means medical treatments like hormone therapy or chemotherapy given before the main treatment to shrink a tumor.
You have a history of non-breast cancer malignancies, which refers to other types of cancer not related to the breast, and you have not been cancer-free for more than 5 years, unless it was a specific low-risk type like certain skin or colon cancers.
You have a non-malignant severe disease, which is a serious health condition that is not cancer, and it is expected to limit your life expectancy to less than 10 years.
You have BRCA1, BRCA2, or other high-risk germline mutations, which are inherited genetic changes that significantly increase the risk of developing breast cancer.
You have participated in another medical study within the 30 days before joining this trial.
You are unable or unwilling to follow the medical check-ups required by the study due to personal, social, or location-related reasons.
You are currently under protective custody or guardianship, meaning you are under the legal control of someone else or the state.
You have already received or are scheduled to receive adjuvant chemotherapy, which is treatment given after the main treatment to prevent the cancer from returning.
You have a medical reason why you cannot undergo radiotherapy (the use of high-energy rays to kill cancer cells) or if you have already had partial breast irradiation.
You have had a mastectomy, which is the surgical removal of one or both breasts, and have already received or are scheduled to receive radiation treatment.
You have invasive lobular breast cancer, a specific type of cancer that starts in the milk-producing glands of the breast.
You have cancer in both breasts or a history of cancer in either the same breast or the opposite breast.
You have multifocal or multicentric disease, which means there are multiple separate areas of cancer within the breast.
Your cancer is limited to microinvasion, meaning the cancer cells are extremely small (less than 1 mm).
There is evidence of lymphovascular invasion, which means cancer cells have been found in the blood vessels or the lymph vessels.

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Verified sites

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

Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Exemestane
is a type of hormone therapy used to treat certain types of breast cancer by lowering the amount of estrogen in the body.
Anastrozole
is a hormone therapy that works by blocking the production of estrogen, which helps to prevent the growth of hormone-sensitive breast cancer cells.
Letrozole
is a medication used in hormone therapy to decrease the levels of estrogen in the body to help manage breast cancer.
Tamoxifen
is a hormone therapy medication that works by blocking the effects of estrogen on breast cancer cells, helping to prevent the cancer from growing or returning.

What is already known about the treatment

Exemestane
This medication is taken by mouth as a pill and is widely used in modern medicine to treat certain types of breast cancer. It belongs to a group of drugs called aromatase inhibitors, which work by blocking an enzyme in the body that produces estrogen. By lowering estrogen levels, it helps prevent cancer cells from growing and spreading.
Anastrozole
This medicine is administered orally and is an established treatment for hormone-sensitive breast cancer. It is classified as an aromatase inhibitor, which means it works at a molecular level to stop the body from making estrogen. Because many breast cancers use estrogen to grow, this drug helps slow down or stop the cancer's progress.
Letrozole
Taken as an oral pill, this drug is a well-known treatment used to manage hormone receptor-positive breast cancer. It belongs to the aromatase inhibitor class and functions by interfering with the chemical process that creates estrogen in the body. Reducing the amount of available estrogen helps to starve cancer cells of the fuel they need to multiply.
Tamoxifen
This medication is used orally and is a common, long-standing treatment for various types of breast cancer. It is classified as a selective estrogen receptor modulator, which works by attaching to estrogen receptors on cancer cells to block estrogen from binding. This action prevents the hormone from signaling the cancer cells to grow and divide.

Investigated diseases

Early breast cancer - This condition involves cancer cells that are located only within the breast tissue and have not spread to the lymph nodes or distant parts of the body. The disease begins when abnormal cells grow uncontrollably within the breast ducts or lobules. In specific cases, these cells may be influenced by hormones like estrogen or progesterone. The progression is characterized by the size of the tumor and whether it remains localized to the original site. As it develops, the cancer can potentially grow within the breast or move to nearby structures.