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Study on Reducing Hormone Therapy Duration with Exemestane, Letrozole, and Anastrozole in Post-Menopausal Women with Low-Risk Hormone-Sensitive 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 clinical trial is focused on studying a type of breast cancer known as hormone receptor-positive (HR+) HER2-negative breast cancer in post-menopausal women. The study is specifically looking at women who have a very low risk of the cancer spreading to other parts of the body, known as metastasis. The treatment being studied involves the use of medications called aromatase inhibitors, which include exemestane, letrozole, and anastrozole. These medications are taken orally in the form of tablets.

The purpose of the study is to see if a shorter duration of hormone therapy, specifically two years, is effective in maintaining a high rate of survival without the cancer spreading over a period of five years. Participants in the study will take one of the aromatase inhibitors for up to two years. The study will monitor the participants' health and any side effects they may experience during this time. The goal is to determine if reducing the length of hormone therapy can still provide effective treatment for this type of breast cancer.

Throughout the study, researchers will track several outcomes, including how long participants remain free from distant metastasis, which means the cancer has not spread to other parts of the body. They will also look at overall survival rates, quality of life, and any adverse effects from the treatment. The results from this study will be compared to those from another study where patients received hormone therapy for five years. This comparison will help determine the safety and effectiveness of the shorter treatment duration.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria. This includes being a postmenopausal woman with localized luminal A breast cancer at low risk of metastatic relapse.
Eligibility also requires that the primary tumor has been completely removed and adequate axillary surgery has been performed.
Step 2
Treatment initiation
The treatment involves taking an adjuvant hormone therapy. The options include letrozole, anastrozole, or exemestane. These medications are taken orally.
The therapy is administered for a duration of 2 years. The specific dosage and frequency are determined by the healthcare provider.
Step 3
Treatment duration
The main objective is to demonstrate that a 2-year duration of this therapy is effective in maintaining high survival rates without distant metastasis over 5 years.
Regular follow-ups and assessments are conducted to monitor health status and any potential side effects.
Step 4
Monitoring and follow-up
Throughout the study, various health parameters are monitored, including distant metastasis-free survival, invasive disease-free survival, and overall survival.
Quality of life assessments are also conducted to evaluate the impact of the treatment.
Step 5
Completion
The study is estimated to conclude by March 31, 2034. Upon completion, the data collected will be analyzed to assess the effectiveness and safety of the reduced hormone therapy duration.

Who can join the trial?

12 criteria

Must be a postmenopausal woman. This means you have stopped having periods due to age or surgery.
Eligible to start or have recently started (within the last 4 months) adjuvant hormone therapy with medications like letrozole, anastrozole, or exemestane. These are treatments given after the main treatment to lower the chance of cancer returning.
Willing and able to follow the study plan, including attending scheduled visits and undergoing tests and procedures.
Must be part of a Social Security System or something similar.
Must have signed a written consent form to participate. If unable to sign, a trusted person can sign on your behalf.
Have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can carry out light work.
Have invasive unilateral breast cancer, meaning cancer is in one breast and has spread into surrounding breast tissue.
No signs of metastases, which means the cancer has not spread to other parts of the body.
The primary tumor must be completely removed, and proper surgery on the lymph nodes under the arm must have been done.
Cancer cells must show at least 50% expression of estrogen or progesterone receptors, which are proteins that can attach to hormones and affect cancer growth.
Cancer must be HER2 negative, meaning it does not have high levels of a protein that can promote cancer growth.
Considered to have a luminal A ultralow risk of cancer returning, meaning less than a 5% chance of cancer coming back in 10 years, based on specific tests called MammaPrint® and Blueprint®.

Who cannot join the trial?

5 criteria

Patients who are not post-menopausal. This means women who have not yet gone through menopause, which is when menstrual periods permanently stop.
Patients who do not have localized luminal A breast cancer. This is a specific type of breast cancer that is usually slower growing and has certain hormone receptors.
Patients who are considered at high risk of metastatic relapse. This means the cancer is likely to spread to other parts of the body.
Patients who are not female, as the study is only for women.
Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care, such as those with certain disabilities or conditions.

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Verified sites

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

Centr Georges Francois Leclerc
Verified
Dijon, France
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Centre Francois Baclesse
Verified
Caen, France

Trial locations

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Investigated drugs

Aromatase Inhibitor is a type of medication used in this trial to help reduce the risk of breast cancer returning. It works by lowering the amount of estrogen in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow. In this study, the focus is on using this medication for a shorter period to see if it is still effective in preventing cancer from coming back in women who are at a very low risk of metastasis.

What is already known about the treatment

Aromatase Inhibitor – This medication is administered orally and is used in the treatment of post-menopausal women with localized luminal A breast cancer who are considered at low risk of metastatic relapse. Currently, it is being studied in clinical trials to evaluate its effectiveness when used for a limited duration of two years as adjuvant endocrine therapy. The main therapeutic indication is to reduce the risk of cancer recurrence in hormone receptor-positive, HER2-negative breast cancer. At the molecular level, aromatase inhibitors work by blocking the enzyme aromatase, which is responsible for converting androgens into estrogens, thereby reducing estrogen levels and slowing the growth of estrogen-dependent cancer cells. This medication falls under the pharmacological classification of hormone therapy.

Investigated diseases

Localized Luminal A Breast Cancer – This is a type of breast cancer that is typically found in post-menopausal women. It is characterized by cancer cells that are hormone receptor-positive and HER2-negative, which means they grow in response to hormones like estrogen. Luminal A breast cancer is generally considered to be a slow-growing cancer with a lower risk of spreading to other parts of the body. It is often detected at an early stage when it is still confined to the breast tissue. The progression of this cancer is usually gradual, and it is often associated with a favorable prognosis compared to other types of breast cancer.