Study of Trastuzumab Deruxtecan for Patients with HER2-Positive Metastatic Breast Cancer Resistant to Trastuzumab, Pertuzumab, and Taxane Treatment

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What is this study about?

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 is investigating a treatment called trastuzumab deruxtecan, also known by its code name DS-8201a. This medication is a combination of a HER2-targeted antibody and a topoisomerase I inhibitor, which is designed to target and kill cancer cells more effectively.

The purpose of the study is to evaluate how well trastuzumab deruxtecan works in patients whose cancer has not responded well to previous treatments, specifically those involving trastuzumab, pertuzumab, and taxane. Participants in the study will receive the medication through an intravenous infusion, which means it will be administered directly into a vein. The study will monitor the participants over a period to assess the treatment’s impact on the cancer, including how long it takes for the cancer to progress and the overall survival of the patients.

Throughout the study, researchers will also keep track of any side effects or adverse reactions to the treatment. This will help determine the safety and tolerability of trastuzumab deruxtecan. The study aims to provide valuable information on whether this treatment can be a viable option for patients with HER2-positive metastatic breast cancer who have not had success with other therapies.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. These assessments include a review of your medical history, a physical examination, and various laboratory tests to ensure your organs and bone marrow are functioning adequately.

You will also have an echocardiogram or a multiple-gated acquisition scan to measure your heart’s left ventricular ejection fraction, which must be at least 50%. Additionally, a pregnancy test will be conducted if applicable.

2 treatment administration

Once eligibility is confirmed, you will begin treatment with the medication trastuzumab deruxtecan, also known as DS-8201a. This medication is administered as a solution for infusion, meaning it is given through a vein in your arm (intravenously).

The dosage and frequency of administration will be determined by the study protocol, and you will receive this treatment regularly as specified by the trial schedule.

3 regular follow-up visits

Throughout the trial, you will have regular follow-up visits. These visits are essential to monitor your health and the effects of the treatment. During these visits, you will undergo physical examinations, laboratory tests, and imaging studies to assess the response of your cancer to the treatment.

The study team will also monitor for any side effects or adverse events you may experience. It is important to report any new symptoms or changes in your health to the study team promptly.

4 end of treatment evaluation

At the end of the treatment period, you will have a final evaluation. This evaluation will include a comprehensive assessment of your health and the overall response of your cancer to the treatment.

The study team will discuss the results with you and provide guidance on the next steps in your care.

Who Can Join the Study?

Must provide a written and signed agreement to participate in the study.
Heart function must be normal, with a left ventricular ejection fraction (LVEF) of at least 50%. This is a measure of how well the heart pumps blood.
Must have normal organ and bone marrow function, which includes:
- Absolute Neutrophil Count (ANC) of at least 1,500 cells per microliter. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count of at least 100,000 per microliter. Platelets help with blood clotting.
- Hemoglobin level of at least 9 grams per deciliter. Hemoglobin is a protein in red blood cells that carries oxygen.
- Creatinine clearance of at least 30 mL/min. This measures how well the kidneys are working.
- Total serum bilirubin within normal limits, unless there is a specific liver condition or liver spread of cancer.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels within normal limits, unless there is liver spread of cancer.
- Alkaline phosphatase (ALP) levels within normal limits, unless there is bone or liver spread of cancer.
- Serum albumin level of at least 2.5 grams per deciliter. Albumin is a protein made by the liver.
Blood clotting tests, INR and aPTT, must be within normal limits.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures required by the study.
For women who can have children, a negative pregnancy test is required unless they have had a permanent sterilization procedure.
Must be at least 18 years old.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means they are fully active or have some symptoms but do not need bed rest.
Must have a life expectancy of at least 12 weeks.
Must have breast cancer that has returned and cannot be removed by surgery, or has spread to other parts of the body.
Must have a confirmed HER2-positive status, which is a specific type of breast cancer, determined by a local laboratory.
Must have a confirmed Hormone Receptor (HR) status, which can be positive or negative, determined by a local laboratory.
Must have previously received anti-HER2 therapy, including trastuzumab and pertuzumab, and experienced a relapse during or within 12 months after the therapy.
Must have measurable disease as assessed by the investigator using specific criteria (RECIST version 1.1).

Who Cannot Join the Study?

Patients who have a different type of cancer that has spread to other parts of the body.
Patients who have not been diagnosed with HER2-positive breast cancer. This is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2, which promotes the growth of cancer cells.
Patients who have not shown resistance to trastuzumab-pertuzumab based therapy. This means the cancer has not stopped responding to these specific treatments.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who are pregnant or breastfeeding.
Patients with serious health conditions that could interfere with the study.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Del Mar	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Universitario De Jaen	Jaen	Spain
Hospital Universitario San Juan De Alicante	Sant Joan D'alacant	Spain
Hospital Universitario De Fuenlabrada	Fuenlabrada	Spain
Hospital De Galdakao Usansolo	Galdakao	Spain
Hqcsajbm Ujhvdtatlbxnb Mbufdny Dc Volrzrbmty	Santander	Spain
Hbkojgwx Uxsmhfdzwaqpp Dz Befdsor	Badajoz	Spain
Fzmuwfcqw Psub Lv Ierbjluzteobg Bcdylzdav Dqw Hmumozez Uewsffhvqrbco Lu Pny	Madrid	Spain
Hkljkddt Uzaigsrpijcmk du A Cnwbca	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	21.09.2023

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan

Trastuzumab deruxtecan is a medication used in this clinical trial to treat a specific type of breast cancer known as HER2-positive breast cancer. This type of cancer has high levels of a protein called HER2, which promotes the growth of cancer cells. Trastuzumab deruxtecan is designed to target and attach to the HER2 protein on the surface of cancer cells. Once attached, it delivers a powerful anti-cancer drug directly into the cancer cells, helping to kill them and slow down the progression of the disease. This medication is being tested in patients whose cancer has not responded well to previous treatments involving other HER2-targeting drugs.

Investigated diseases:

HER2 positive breast cancer

Metastatic breast cancer – Metastatic breast cancer is a stage of breast cancer where the cancer cells have spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. This spread occurs when cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system. The progression of metastatic breast cancer can vary, with some patients experiencing rapid spread while others may have a slower progression. Symptoms depend on the location of the metastasis and can include bone pain, difficulty breathing, or neurological symptoms. The disease is characterized by its ability to affect multiple organs and systems, leading to a complex clinical picture. Management focuses on controlling the spread and alleviating symptoms.

Trial ID:

2023-503627-26-00

Protocol code:

GEICAM/2021-08

NCT ID:

NCT05744375

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Trastuzumab Deruxtecan for Patients with HER2-Positive Metastatic Breast Cancer Resistant to Trastuzumab, Pertuzumab, and Taxane Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?