Recruiting

Study on Detecting Tumor DNA in Blood for Patients with HR+, HER2 Low Metastatic Breast Cancer Using Trastuzumab Deruxtecan After Standard Therapy

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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 metastatic breast cancer that is hormone receptor-positive (HR+) and has low levels of HER2. The study aims to explore the effectiveness of a treatment called trastuzumab deruxtecan, which is an antibody-drug conjugate. This treatment is given as a solution through an infusion into the vein. The trial will involve patients who are currently receiving standard therapy for this type of breast cancer and will use a blood test to detect tumor DNA, which helps identify patients who might benefit from the new treatment.

The purpose of the study is to determine if switching to trastuzumab deruxtecan after a short period of standard treatment can improve the time patients live without the cancer getting worse. Initially, patients will receive standard treatment with a combination of hormone therapy and a type of medication called a CDK4/6 inhibitor. After one month, patients whose blood tests show persistent tumor DNA will switch to the new treatment. The study will monitor how long patients live without the cancer progressing and will also look at overall survival and response to the treatment.

Throughout the study, patients will have regular assessments to check the status of their cancer. These assessments will occur every six weeks during the first year and every nine weeks thereafter. The study will also track any side effects experienced by participants. The goal is to gather information on how well trastuzumab deruxtecan works in this specific group of breast cancer patients and to understand its safety profile.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Signing consent for treatment phase
Before starting the treatment phase, it is necessary to sign a written informed consent form. This document confirms understanding and agreement to participate in the treatment phase of the study.
Step 2
Discontinuation of previous medication
Discontinue the use of any CDK4/6 inhibitors, such as palbociclib, ribociclib, or abemaciclib, at least 7 days before starting the new treatment, but not more than 14 days prior.
Step 3
CtDNA assessment
A blood test will be conducted to measure circulating tumor DNA (ctDNA) levels after 4 weeks of standard treatment. This test helps determine if there is a molecular response to the treatment.
Step 4
Health status evaluation
An assessment of overall health status will be conducted. This includes checking the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1, indicating full activity or some symptoms but nearly fully ambulatory.
Step 5
Heart function test
A test will be performed to measure the left ventricular ejection fraction (LVEF). The result should be 50% or higher to ensure the heart is functioning properly.
Step 6
Blood and organ function tests
Blood tests will be conducted to ensure adequate bone marrow and organ function. This includes checking levels of neutrophils, platelets, hemoglobin, creatinine, albumin, bilirubin, and liver enzymes.
Step 7
Pregnancy test and contraception
For women of childbearing potential, a pregnancy test will be conducted within 3 days of enrollment. Effective contraception must be used during the study and for at least 7 months after the last dose for women, and 4 months for men.
Step 8
Treatment with trastuzumab deruxtecan
The treatment involves receiving trastuzumab deruxtecan, also known as T-DXd, through an intravenous infusion. The frequency and dosage will be determined by the study protocol.
Step 9
Regular health assessments
Regular health assessments will be conducted to monitor the response to the treatment. Tumor assessments will occur every 6 weeks during the first 12 months and every 9 weeks thereafter.

Who can join the trial?

18 criteria

Patient must have signed the written informed consent for both the screening and treatment phases before any trial-specific procedures.
Patient is 18 years of age or older.
Patient has documented breast cancer that is metastatic (cancer that has spread to other parts of the body) and eligible for biopsy for confirmation.
Cancer must be HER2 low or HER2 ultra low and HR-positive (hormone receptor-positive).
Patient has either a metastatic relapse during or within 1 year after stopping adjuvant endocrine therapy, or a metastatic relapse in specific organs like the lung or liver, occurring more than one year after completing adjuvant therapy.
Patient did not receive any therapy in the metastatic setting.
Patient is eligible for a first-line treatment with a marketed CDK4/6 inhibitor (such as palbociclib, ribociclib, or abemaciclib) in combination with either AI or fulvestrant.
Patient has a measurable or an evaluable disease according to specific medical guidelines.
Availability of an archived metastatic tumor sample for research purposes.
Patient must be willing and able to follow the study protocol, including visits, treatment plans, and tests.
Patient must be registered in a National Health Care System or equivalent.
Patient must have stopped using a CDK4/6 inhibitor at least 7 days before joining the study, but no longer than 14 days.
Patient must show no drop in ctDNA (a type of DNA found in the blood) after 4 weeks of standard treatment.
Patient has an ECOG Performance Status of 1 or less, indicating they are fully active or have some restrictions but can carry out light work.
Patient has a left ventricular ejection fraction (LVEF) of 50% or higher, which measures heart function.
Patient has adequate bone marrow and organ function, as shown by specific laboratory values.
Women of childbearing potential must have a negative pregnancy test within 3 days of joining the study.
Men and women of childbearing potential must agree to use effective contraception during the study and for a specified period after the last dose of study treatment.

Who cannot join the trial?

6 criteria

Patients who do not have Metastatic Breast Cancer HR+, HER2- cannot participate. This means the cancer has spread to other parts of the body, is hormone receptor-positive, and does not have too much of the HER2 protein.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are not expected to develop resistance to the standard treatment cannot participate. This refers to patients whose cancer is not likely to stop responding to the usual treatment.
Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study and includes specific characteristics.
Patients who are not female or male subjects as specified by the study cannot participate. The study includes both genders.
Patients who are not part of the vulnerable population selected for the study cannot participate. This refers to groups that may need special protection or consideration.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

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Investigated drugs

Trastuzumab deruxtecan
is a medication used in this clinical trial to treat patients with a specific type of breast cancer. It is designed to target and attach to cancer cells that have a protein called HER2 on their surface. Once attached, it delivers a powerful anti-cancer drug directly into the cancer cells, helping to destroy them. This medication is being tested to see if it can help patients who are not responding well to their current treatment.
Endocrine therapy
is a treatment used to manage breast cancer by blocking or lowering the amount of hormones in the body, such as estrogen, which can help some types of breast cancer grow. In this trial, endocrine therapy is combined with another medication to see if it can help control the cancer more effectively.
CDK4/6 inhibitors
are a type of medication used in this trial to help stop cancer cells from growing and dividing. They work by blocking certain proteins in the cells that are involved in cell division. By doing this, they can slow down or stop the growth of cancer. These inhibitors are used in combination with other treatments to see if they can improve outcomes for patients with breast cancer.

Trastuzumab Deruxtecan

What is already known about the treatment

Trastuzumab Deruxtecan – This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic breast cancer that is hormone receptor-positive (HR+) and low in human epidermal growth factor receptor 2 (HER2-). The main use of this drug is to help patients who are at high risk of cancer returning after initial treatment. It works by targeting and binding to specific proteins on cancer cells, delivering a chemotherapy agent directly to these cells to help stop their growth. Trastuzumab Deruxtecan is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target cancer cells.

Investigated diseases

Metastatic Breast Cancer HR+, HER2- – This type of breast cancer is characterized by the spread of cancer cells beyond the breast to other parts of the body. It is hormone receptor-positive (HR+), meaning the cancer cells grow in response to hormones like estrogen or progesterone. The cancer is also HER2-negative, indicating that it does not overexpress the HER2 protein, which can promote the growth of cancer cells. The disease progresses as cancer cells continue to multiply and invade other tissues, often affecting organs such as the bones, liver, lungs, or brain. Over time, the cancer may develop resistance to standard treatments, making it more challenging to control. The progression of the disease is monitored through regular assessments to track the spread and growth of cancer cells.