#1 Clinical Trials Search in Europe

Study on the Effectiveness of Trastuzumab Deruxtecan in Patients with HER2-Positive Oligometastatic Breast Cancer

2 1 1

What is this study about?

This clinical trial is focused on studying a specific type of breast cancer known as HER2-positive oligometastatic breast cancer. This type of cancer is characterized by the presence of a limited number of cancerous lesions that have spread to other parts of the body. The treatment being tested in this study is called trastuzumab deruxtecan, also known by its code name DS-8201a. This medication is administered as a solution through an intravenous infusion, which means it is given directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective trastuzumab deruxtecan is when used as part of a combination treatment approach for patients with HER2-positive oligometastatic breast cancer. Participants in the study will receive the medication and will be monitored over a period of time to assess the treatment’s impact on their cancer. The study will also involve regular imaging tests, such as MRI and PET-CT, to track changes in the cancer and determine the treatment’s effectiveness.

Throughout the study, researchers will be looking for a complete response to the treatment, which means that the cancer is no longer detectable on imaging tests. They will also monitor for any side effects that participants may experience. The study aims to provide valuable information on the potential benefits of trastuzumab deruxtecan for patients with this specific type of breast cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of HER2-positive breast cancer with limited metastases.

Initial assessments include imaging tests such as PET-CT and MRI to evaluate the extent of the disease.

2 treatment initiation

The treatment involves the administration of trastuzumab deruxtecan, also known as DS-8201a.

This medication is given as a solution for infusion through an intravenous line.

The frequency and dosage are determined by the study protocol and are administered under medical supervision.

3 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment, including imaging tests to track changes in the cancer.

The primary goal is to achieve a complete radiologic response, as defined by specific criteria.

4 additional treatments

Depending on the response, additional treatments may be planned, such as surgery or radiation, to target remaining cancer cells.

These treatments are scheduled to avoid delays and are part of the comprehensive care plan.

5 follow-up and evaluation

After completing the treatment phase, follow-up evaluations are conducted to monitor for any adverse effects and to ensure the cancer remains under control.

The study aims to track the long-term outcomes and any potential side effects until 30 days after the last treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of HER2-positive breast cancer. This means the cancer cells have a protein called HER2 on their surface, which can be identified through specific tests.
  • Must have proof of breast cancer that has spread to other parts of the body, known as metastases. At least one area of spread must be confirmed.
  • Must have a test to determine the level of ER-expression, which refers to the presence of estrogen receptors on the cancer cells.
  • Must have oligo-metastatic disease, meaning the cancer has spread to a limited number of areas, specifically up to three separate spots. These can be in one organ or spread across 2-3 different organ systems. Certain types of spread, like widespread small spots or spread in the lining of the abdomen, are not allowed.
  • If the cancer has come back after treatment, there must have been a period of at least 24 months without the disease.
  • Must have cancer that can be measured according to specific guidelines called RECIST1.1.
  • Must be at least 18 years old, able to understand the study, and agree to participate by signing a consent form.
  • Must have a World Health Organization (WHO) performance status of 0 or 1, which means the person is fully active or has some symptoms but can still carry out light work.

Who Cannot Join the Study?

  • Patients who do not have HER2-positive breast cancer. HER2-positive means that the cancer cells have more of a protein called HER2, which can make the cancer grow faster.
  • Patients who do not have oligometastatic disease. Oligometastatic disease means that the cancer has spread to a few other parts of the body, but not many.
  • Patients who are not within the specified age range for the study.
  • Patients who are not eligible based on gender requirements for the study.
  • Patients who belong to a vulnerable population that is not selected for this 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

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Netherlands Cancer Institute Amsterdam The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hugspvcq Voyu dveaxhmc Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
15.09.2023
Italy Italy
Not yet recruiting
15.09.2023
Spain Spain
Not yet recruiting
15.09.2023
Sweden Sweden
Not yet recruiting
15.09.2023
The Netherlands The Netherlands
Recruiting
15.09.2023

Trial locations

Investigated drugs:

T-DXd is a medication being studied for its effectiveness in treating patients with HER2-positive oligo-metastatic breast cancer. It is part of a multi-modality treatment approach, which means it is used alongside other treatments to see how well it works in managing this type of cancer.

Investigated diseases:

Breast Cancer, HER2-Positive, Oligometastatic Disease – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. In the oligometastatic stage, the cancer has spread beyond the breast to a limited number of other sites in the body. The progression of this disease involves the growth and potential spread of cancerous cells, which can affect various organs. HER2-positive cancers tend to grow and spread more aggressively than other types of breast cancer. The disease’s behavior can vary, with some cases remaining stable for a period while others may progress more rapidly. Understanding the specific characteristics of the cancer, such as its HER2 status, is crucial in determining its progression and potential impact on the body.

Trial ID:
2023-505039-11-00
NCT ID:
NCT05982678
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Comparing RO7771950 with a drug combination of tucatinib, trastuzumab, and capecitabine in patients with HER2-positive metastatic or locally advanced breast cancer

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +5

  • Phase 1b-2 Study of Elacestrant and Abemaciclib in Patients with Brain Metastases from ER-Positive, HER2-Negative Breast Cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Germany Greece Italy Spain