Study Comparing Trastuzumab Deruxtecan and Trastuzumab Emtansine for Patients with Advanced HER2-Positive Breast Cancer

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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 comparing two treatments: trastuzumab deruxtecan, also known by its code name DS-8201a, and ado-trastuzumab emtansine, commonly referred to as T-DM1. Both treatments are designed to target and attack cancer cells that have high levels of the HER2 protein.

The purpose of the study is to determine which of these two treatments is more effective in delaying the progression of the disease. Participants in the study will receive one of the two treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will follow participants over a period of time to monitor the effects of the treatments on their cancer.

Participants in this study have previously been treated with a medication called trastuzumab and a type of chemotherapy known as taxane. The study aims to provide valuable information on the effectiveness of these new treatment options for patients with advanced breast cancer. The results could help improve future treatment strategies for this type of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and previous treatments.

The study involves patients with HER2-positive breast cancer that is either not removable by surgery or has spread to other parts of the body.

2 treatment assignment

Participants are randomly assigned to receive either trastuzumab deruxtecan (DS-8201a) or ado-trastuzumab emtansine (T-DM1).

Both medications are administered as a solution through an intravenous infusion.

3 medication administration

The medication is given through a vein in the arm, known as an intravenous infusion.

The frequency and dosage of the medication are determined by the study protocol and the healthcare team.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to the treatment and any side effects.

This includes physical exams, blood tests, and imaging studies to track the progress of the cancer.

5 completion of treatment

The treatment continues until the study’s end date or until it is determined that the treatment is no longer beneficial.

Participants are required to follow specific guidelines regarding contraception during and after the study to prevent pregnancy.

6 follow-up

After completing the treatment, follow-up visits are scheduled to monitor long-term health and any delayed side effects.

The study aims to compare the time during which the cancer does not worsen between the two treatments.

Who Can Join the Study?

  • Must be an adult aged 18 years or older. If the legal age of consent is higher than 18, that age applies.
  • Must have breast cancer that is either unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body).
  • The cancer must have a confirmed HER2 positive expression, which means the cancer cells have more HER2 proteins than normal, as determined by specific guidelines.
  • Must have been previously treated with the drugs trastuzumab and taxane in advanced or metastatic settings, or the cancer progressed within 6 months after treatment that included these drugs.
  • Must show documented radiologic progression, meaning the cancer has grown or spread as seen in medical imaging, during or after the most recent treatment, or within 6 months after completing therapy.
  • Must be confirmed as HER2 positive by a central laboratory using the most recent tumor tissue sample available.
  • Female participants who can have children must agree to use a highly effective form of birth control or avoid intercourse during the study and for at least 7 months after the last dose of the study drugs. Male participants must inform potential female partners about the trial and agree to use birth control or avoid intercourse during the study and for at least 4.5 months after the last dose of the study drugs.
  • Must have adequate renal function, meaning the kidneys are working well enough, with a creatinine clearance of at least 30 mL/min.
  • Must have adequate hepatic function, meaning the liver is working well enough, with total bilirubin levels within specific limits and liver enzymes (AST/ALT) not exceeding 5 times the upper limit of normal.

Who Cannot Join the Study?

  • Patients who have not been previously treated with trastuzumab and taxane. These are specific types of cancer treatments.
  • Patients with breast cancer that is not HER2-positive. This means the cancer does not have high levels of a protein called HER2.
  • Patients whose breast cancer is not unresectable or metastatic. “Unresectable” means the cancer cannot be removed with surgery, and “metastatic” means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hospital Clinico San Carlos Madrid Spain
Katholieke Universiteit te Leuven Leuven Belgium
Comite Entreprise Paul Papin Angers France
IRCCS Humanitas Research Hospital Rozzano Italy
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Institut Jules Bordet Anderlecht Belgium
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Institut Sainte Catherine Avignon France
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital Quironsalud Barcelona Barcelona Spain
Hospital Universitario Virgen Macarena Sevilla Spain
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Canarias La Laguna Spain
Vrije Universiteit Brussel Jette Belgium
Clinique Victor Hugo Le Mans France
Centre Francois Baclesse Caen France
Ingqttmg Rzbdxheg De Citcsm Dg Mlphckjdkev Montpellier France
Ayrdnms Otzpfgaseuf Uthelqxyarnll Pmtgo Parma Italy
Cyzzpu Ltzk Bmoccu Lyon France
Ixzcuozf Cwlotj Djfjvbivcqshfiqfe L'hospitalet De Llobregat Spain
Hjmsuqyr Uzfvsksbrcmfh Dn Bdzddjy Badajoz Spain
Azwomtkxml Pgjauijs Hslokfhl Db Mnjbczpiv Marseille France
Uzswzvbmnr Om Ahanvrm Edegem Belgium
Aioecdw Oblsvufbwtz Pilv Grmvvobq Xelit Bergamo Italy
Hvxmypmb Vxbm dcdbztek Barcelona Spain
Hzcuxjsj Uglwhaezaftvg de A Cbgthm A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
08.04.2019
France France
Not recruiting
08.04.2019
Italy Italy
Not recruiting
08.04.2019
Spain Spain
Not recruiting
08.04.2019

Trial locations

Trastuzumab Deruxtecan (DS-8201a) is a medication used in this clinical trial. It is an anti-HER2-antibody drug conjugate, which means it is designed to target and attach to HER2 proteins on cancer cells. Once attached, it delivers a chemotherapy drug directly to the cancer cells, helping to destroy them. This medication is being tested for its effectiveness in treating HER2-positive, unresectable, and/or metastatic breast cancer in patients who have already been treated with trastuzumab and a taxane.

Ado-Trastuzumab Emtansine (T-DM1) is another medication involved in the trial. It is also an anti-HER2-antibody drug conjugate, similar to trastuzumab deruxtecan. It works by binding to the HER2 proteins on cancer cells and delivering a chemotherapy drug to these cells. This medication is used as a comparison to evaluate the effectiveness of trastuzumab deruxtecan in the study. It is intended for patients with HER2-positive, unresectable, and/or metastatic breast cancer who have previously received treatment with trastuzumab and a taxane.

Metastatic breast cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is considered an advanced stage of breast cancer, often referred to as stage IV. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms can vary depending on where the cancer has spread, but may include bone pain, difficulty breathing, or neurological symptoms. The progression of metastatic breast cancer can be influenced by factors such as the cancer’s hormone receptor status and HER2 status. It is a chronic condition that requires ongoing management to control the spread and alleviate symptoms.

Trial ID:
2024-511204-16-00
Protocol code:
DS8201-A-U302
NCT ID:
NCT03529110
Trial Phase:
Therapeutic confirmatory (Phase III)

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