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 study about?

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Clinique de Flandre	Coudekerque Branche	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Blois Simone Veil	Blois	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Prive Saint-Gregoire	Saint-Gregoire	France
Clinique Pasteur Lanroze	Brest	France
Institut Godinot	Reims	France
Centre Hospitalier William Morey	Chalon Sur Saone	France
Clinique De La Sauvegarde	Lyon	France
Hopital Prive Jean Mermoz	Lyon	France
Clinique de l’Europe	Amiens	France
Centre Hospitalier Alpes Leman	74130	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier De Cholet	Cholet	France
Hopital Prive Des Cotes D’armor	Plerin	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
Centre Hospitalier D Auxerre	Auxerre	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Centre Hospitalier Simone Veil De Beauvais	Beauvais	France
Institut Sainte Catherine	Avignon	France
Immobiliere De Nancy	Nancy	France
Pôle Santé République	Clermont Ferrand	France
Centre Hospitalier De Pau	Pau	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Iojqigsx Rvyplvon Df Cttsyc Du Mjpwzhtoafy	Montpellier	France
Cavdnj Lgic Bsskvy	Lyon	France
Haezqohs di Lalex	Thonon-les-bains	France
Cijknz Habwaodbxln Iudkmgcjftluw Dw Fcwshgqmepyynitujugwk	Frejus	France
Chhrfv da Rwipxisxjxicg &fabmjg Ckrttdms Spfkpt Abve	STRASBOURG, Alsace	France
Ajimimwhkm Pxbdgkhi Hbojcgcw Db Pylvp	Paris	France
Ixhxlkof Povanwinpaeuddv Cjwwxc Cvgkae	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan

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.

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.

Trial ID:

2024-515349-41-00

Protocol code:

UC-GMP-2402

NCT ID:

NCT06680596

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?