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Study on Stopping or Continuing Anastrozole, Letrozole, and Exemestane for Patients with Advanced or Metastatic Low-Grade Endometrial Stromal Sarcoma

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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 cancer called low-grade endometrial stromal sarcoma, which is a rare form of cancer that affects the lining of the uterus. The study is investigating the effects of stopping versus continuing treatment with medications known as aromatase inhibitors. These medications include Anastrozole (also known as Arimidex), Letrozole, and Exemestane (also known as Aromasin). Aromatase inhibitors are used to lower estrogen levels in the body, which can help slow the growth of certain types of cancer cells.

The purpose of the study is to compare the outcomes of patients who continue taking aromatase inhibitors with those who stop taking them. Participants in the study will be randomly assigned to either continue their current treatment or to stop it. The study will monitor the progression of the disease over time to see if there is a difference in how long patients remain free from cancer growth. This is known as progression-free survival. The study will also look at other factors such as overall survival, safety, quality of life, and the time until further treatment is needed.

Participants will be involved in the study for a period of time, during which they will receive regular check-ups and assessments to monitor their health and the status of their cancer. The study aims to provide valuable information on the best approach to managing low-grade endometrial stromal sarcoma with aromatase inhibitors, potentially improving treatment strategies for patients with this condition.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.
The patient must have a confirmed diagnosis of low grade endometrial stromal sarcoma and have been treated with an aromatase inhibitor for a specified duration.
Step 2
Randomization
The patient is randomly assigned to one of two groups: one group will continue the aromatase inhibitor treatment, while the other group will have the treatment interrupted.
This step is crucial to compare the effects of maintaining versus interrupting the treatment.
Step 3
Treatment phase
Patients in the maintenance group will continue taking their prescribed aromatase inhibitor, which could be anastrozole, letrozole, or exemestane, orally as a film-coated or coated tablet.
The dosage for anastrozole is 1 mg, and for exemestane, it is 25 mg. The frequency and duration of administration are determined by the study protocol.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the patient's health status and the progression of the disease.
Assessments include measuring progression-free survival, overall survival, safety, quality of life, and time to first subsequent chemotherapy.
Step 5
End of study participation
The study is estimated to conclude by January 24, 2028.
At the end of the study, final assessments are conducted to evaluate the outcomes of the treatment strategies.

Who can join the trial?

8 criteria

Must be at least 18 years old.
Must have a confirmed diagnosis of **low grade endometrial stroma sarcoma (LGESS)**, which is a type of cancer that affects the lining of the uterus.
Must have experienced a tumor breaking through during surgery, or have locally advanced or metastatic disease at diagnosis, or have had the disease return after initial treatment.
Must have been treated with an **aromatase inhibitor** (a type of medication that lowers estrogen levels) such as Anastrozole, Exemestane, or Letrozole for at least 24 months if there is no remaining or measurable disease, or for at least 36 months if there is measurable disease.
The disease must be under control at the time of randomization, meaning the disease is either responding to treatment or stable, with the use of aromatase inhibitors for the required duration.
Must have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 2 or less, which is a scale used to assess how a patient's disease is affecting their daily living abilities. A score of 2 means the patient is capable of all self-care but unable to carry out any work activities.
Must have medical insurance coverage.
Must have signed an informed consent form before any study-specific procedures are done, indicating they understand the study and agree to participate.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of locally advanced or metastatic low-grade endometrial stroma sarcoma cannot participate.
Patients who are not female cannot participate.
Patients who are under the age of 18 cannot participate.
Patients who are part of a vulnerable population, meaning they may have difficulty understanding or consenting to the study, cannot participate.

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Verified sites

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

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Besancon University Hospital Center
Besançon, France
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Centre Francois Baclesse
Caen, France

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Investigated drugs

Aromatase Inhibitors are medications used in this trial to manage hormone levels in patients with locally advanced or metastatic low-grade endometrial stromal sarcoma. These medications work by reducing the amount of estrogen in the body, which can help slow the growth of certain types of cancer cells that rely on estrogen to grow. The trial is comparing the effects of continuing versus stopping these medications to see which approach is more effective in prolonging the time patients live without their cancer getting worse.

What is already known about the treatment

Aromatase Inhibitors – These medications are typically administered orally in the form of tablets. They are currently well-established in medical practice and literature, particularly for their role in treating hormone-sensitive cancers. The main therapeutic indication for aromatase inhibitors is to manage conditions like locally advanced or metastatic low-grade endometrial stromal sarcoma by reducing estrogen levels in the body. At the molecular level, they work by blocking the enzyme aromatase, which is responsible for converting androgens into estrogens, thereby lowering estrogen levels and slowing the growth of estrogen-dependent tumors. Aromatase inhibitors are classified as hormone therapy drugs.

Investigated diseases

Endometrial Stromal Sarcoma – Endometrial stromal sarcoma is a rare type of cancer that originates in the connective tissue of the uterus. It is characterized by the abnormal growth of cells in the endometrial stroma, which is the supportive tissue of the uterine lining. This disease can be classified into low-grade and high-grade forms, with low-grade endometrial stromal sarcoma (LGESS) being less aggressive. LGESS tends to grow slowly and may spread to nearby tissues or distant parts of the body over time. Symptoms can include abnormal uterine bleeding, pelvic pain, or a noticeable mass in the pelvic area. The progression of the disease can vary, and it may remain stable for long periods before showing signs of advancement.