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Study on Reducing Treatment for Patients with HER2-Positive Metastatic Breast Cancer Using Trastuzumab and Drug Combination After 2 Years of Controlled Disease

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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 HER2-positive metastatic breast cancer. This is a form of cancer that has spread beyond the breast and is characterized by an overexpression of the HER2 protein. The study involves patients whose cancer has been controlled after two years of ongoing treatment with medications that specifically target the HER2 protein. These medications include Trastuzumab, Pertuzumab, Trastuzumab Emtansine, and Trastuzumab Deruxtecan. The purpose of the study is to explore the possibility of reducing the intensity of these treatments in patients who show no detectable cancer levels in their blood tests, specifically in circulating tumor DNA (ctDNA).

Participants in the study will undergo a period of reduced treatment to see if their cancer remains controlled. This approach is known as therapeutic de-escalation. The study will monitor the patients' health and cancer status over time to determine if the reduced treatment is effective. The study will also involve regular blood tests to check for any signs of cancer returning. If the cancer does show signs of returning, the original treatment may be reintroduced. The study aims to find out if it is safe and effective to give patients less medication while still keeping the cancer under control.

The study will last for a maximum of 36 months, during which time patients will be closely monitored. The main goal is to see if the cancer remains stable without the full intensity of the original treatment. This could potentially lead to fewer side effects and an improved quality of life for patients. The study will also assess the overall health and well-being of participants, including their quality of life and any feelings of anxiety or regret about their treatment decisions. The results of this study could help guide future treatment plans for patients with HER2-positive metastatic breast cancer.

The research process

The trial runs in 6 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, a written informed consent must be signed. If unable to sign, a trusted person can sign on your behalf.
A series of tests will be conducted to ensure adequate heart, kidney, blood, and liver functions.
Step 2
Initial assessments
A pregnancy test is required for women of childbearing potential within 28 days before inclusion.
Non-menopausal women and fertile men must agree to use non-hormonal contraception methods during the study.
Step 3
Treatment history review
A review of your treatment history will confirm that you have received continuous anti-HER2 targeted therapy for at least 2 years.
This includes treatments such as trastuzumab, pertuzumab, trastuzumab emtansine, or trastuzumab deruxtecan.
Step 4
Treatment de-escalation
The main objective is to evaluate the feasibility of reducing treatment in cases where the disease is controlled and cancer levels are undetectable in blood tests.
Regular monitoring will be conducted to assess the progression-free rate, which is the time from registration to the first documented event of cancer progression or death.
Step 5
Monitoring and follow-up
During the study, regular visits will be scheduled to monitor your health and the effectiveness of the treatment.
Quality of life will be assessed using specific questionnaires to evaluate aspects such as anxiety and decision regret.
Step 6
End of study
The study is estimated to end by November 14, 2029.
Final assessments will be conducted to evaluate the overall outcomes and any long-term effects of the treatment de-escalation.

Who can join the trial?

14 criteria

The patient must have signed a written informed consent before any trial-specific procedures. If the patient cannot sign, a trusted person can sign on their behalf.
The patient must have adequate heart, kidney, blood, and liver functions according to hospital guidelines.
Women who can have children must have a negative pregnancy test within 28 days before joining the study.
Women who are not post-menopausal and men who can father children must agree to use effective birth control methods during the study. Hormonal contraceptives like birth control pills, patches, implants, or injections are not allowed for patients who are hormone receptor positive.
The patient must be willing and able to follow the study plan, including scheduled visits, treatment, and other procedures.
The patient must be part of a Social Security System or equivalent.
The patient must be at least 18 years old.
The patient must have a documented diagnosis of locally advanced inoperable or metastatic breast cancer that is HER2-positive. This means the cancer has a specific protein called HER2 that is present in high amounts.
The patient must have an adequate tumor tissue sample available for a special test called NGS analysis to design the ctDNA test. This test is based on the most recent tumor tissue sample, excluding bone tissue.
The patient must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
The patient must have received continuous anti-HER2 targeted therapy for at least 2 years for their breast cancer, with a complete or partial response at the last radiological assessment. A treatment break of up to 3 months is allowed.
If the patient has only bone disease, a complete metabolic response in a special scan called an 18-FDG PET scan is required.
The patient must have a treated and controlled primary tumor, which means the original tumor has been managed with surgery and/or radiation therapy.
Patients with ER-positive disease may have received additional hormone therapy, which should be continued if already in use. Additional ovarian suppression using LHRH agonists is allowed.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with HER2-positive breast cancer. HER2-positive means that the cancer has a protein called HER2 on the surface of its cells, which promotes the growth of cancer cells.
Patients whose breast cancer is not locally advanced or metastatic. Locally advanced means the cancer has spread beyond the breast to nearby tissues, and metastatic means the cancer has spread to other parts of the body.
Patients who have not been on maintenance treatment with anti-HER2 targeted therapy for at least 2 years. Anti-HER2 targeted therapy is a treatment that specifically targets and blocks the HER2 protein to stop cancer growth.
Patients who have not achieved disease control after 2 years of maintenance treatment.
Patients who have not tested negative for ctDNA. ctDNA stands for circulating tumor DNA, which is DNA from cancer cells that is found in the blood.

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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
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Anti-HER2 Targeted Therapy is a type of treatment specifically designed to target and block the HER2 protein, which can promote the growth of cancer cells. In this clinical trial, patients with HER2-positive metastatic breast cancer receive this therapy to help control the disease. The goal is to see if it's possible to reduce the amount of medication needed while still keeping the cancer under control, especially for those who have shown a good response to treatment over a long period.

What is already known about the treatment

Anti-HER2 Targeted Therapy – This medication is administered to patients with HER2-positive breast cancer, typically in the form of an injection or infusion. It is currently used in medical practice to manage advanced breast cancer that cannot be surgically removed or has spread to other parts of the body. The main therapeutic indication is for patients whose cancer is under control after two years of maintenance treatment. At the molecular level, this therapy works by targeting and blocking the HER2 protein, which is involved in the growth of cancer cells. It is classified pharmacologically as a targeted therapy, specifically designed to interfere with specific molecules involved in tumor growth and progression.

Investigated diseases

HER2-positive metastatic breast cancer – This is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, which promotes the growth of cancer cells. It is considered metastatic when the cancer has spread beyond the breast to other parts of the body. The disease often progresses through stages, starting from localized breast tissue and potentially advancing to lymph nodes and distant organs. The progression can be monitored through imaging techniques and molecular markers, such as circulating tumor DNA (ctDNA). Over time, the cancer may become resistant to initial treatments, necessitating changes in therapeutic strategies. The disease's progression is typically evaluated using criteria like RECIST 1.1, which assesses changes in tumor size and spread.