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Study on the Safety and Effects of Trastuzumab Deruxtecan with Drug Combination for Patients with Metastatic HER2-low 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 . This is a form of breast cancer that has spread to other parts of the body and shows low levels of a protein called HER2. The study will explore the effects of a treatment called (also known as T-DXd) when used in combination with other cancer-fighting medications. These medications include , , (also known as MEDI4736), , , and (also known as AZD-5363). The purpose of the study is to assess the safety and effectiveness of these combinations in treating HER2-low metastatic breast cancer.

The study is designed in two parts. In the first part, researchers will determine the best dose of T-DXd when combined with the other medications. In the second part, they will further evaluate the safety and tolerability of these combinations at the determined dose. Participants will receive the treatments through different methods, such as intravenous infusion (a method where the medication is given directly into a vein) or oral tablets. The study will monitor how the body responds to the treatment and any side effects that may occur.

Throughout the study, researchers will collect information on how well the treatment works in shrinking the cancer and how long it takes for the cancer to progress. They will also measure the levels of T-DXd and other substances in the blood to understand how the treatment is processed by the body. The study aims to provide valuable insights into new treatment options for patients with HER2-low metastatic breast cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of breast cancer, and previous treatments.

A tumor sample is required for biomarker assessment to ensure the study’s suitability.

2 part 1: dose-finding phase

This phase aims to determine the appropriate dose of trastuzumab deruxtecan (T-DXd) in combination with other medications.

Medications include paclitaxel (intravenous), fulvestrant (intramuscular), durvalumab (intravenous), and anastrozole (oral).

The focus is on assessing safety and tolerability, with regular monitoring for any adverse effects.

3 part 2: dose-expansion phase

This phase uses the recommended dose determined in Part 1 to further assess safety and tolerability.

Patients may receive capecitabine (oral) and capivasertib (oral) as part of the treatment regimen.

The goal is to evaluate the treatment’s effectiveness in managing metastatic breast cancer.

4 monitoring and assessments

Throughout the trial, regular assessments are conducted to monitor the treatment’s impact on the cancer.

These assessments include measuring the size of the tumor and checking for any side effects.

Blood tests are performed to measure the concentration of medications in the body.

5 completion of the trial

The trial is expected to conclude by July 2026.

Final assessments will determine the overall effectiveness and safety of the treatment combination.

Who Can Join the Study?

  • Patients must be at least 18 years old.
  • Both male and female patients can participate.
  • Patients must have breast cancer that is confirmed by a medical test.
  • The cancer must show a history of HER2-low expression. This means the cancer has low levels of a protein called HER2, which is checked using specific tests.
  • The cancer must be either HR+ or HR-. HR+ means the cancer has hormone receptors, which are proteins that hormones can attach to. HR- means the cancer does not have these receptors.
  • Patients must provide a sufficient sample of their tumor for testing.
  • Patients must have an ECOG Performance Status of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • For patients with HR+ disease:
    • In Part 1: Patients must have had at least one previous treatment with hormone therapy, with or without additional targeted therapy, and at least one previous chemotherapy treatment for metastatic breast cancer.
    • In Part 2: Patients can have had only one previous hormone therapy treatment, with or without additional targeted therapy, and no previous chemotherapy for metastatic breast cancer.
  • For patients with HR- disease:
    • In Part 1: Patients must have had at least one previous chemotherapy treatment for metastatic breast cancer.
    • In Part 2: For Module 2, no previous treatments for metastatic breast cancer are allowed. For Modules 1 and 3, only one previous chemotherapy treatment for metastatic breast cancer is allowed.

Who Cannot Join the Study?

  • Patients who do not have metastatic breast cancer. This means the cancer has spread to other parts of the body.
  • Patients who do not have HER2-low breast cancer. HER2 is a protein that can affect the growth of cancer cells. HER2-low means the cancer cells have a small amount of this protein.
  • Patients who have already received more than one prior treatment for advanced or metastatic disease. This means if you have had more than one treatment for cancer that has spread, you cannot participate.
  • Patients who are not in the age range specified for the study. The study may have specific age requirements.
  • Patients who are not part of the specified gender group. The study may be open to both males and females, or just one gender.
  • Patients who are considered part of a vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium

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
21.03.2022

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan (T-DXd) is a medication being studied for its potential to treat metastatic HER2-low breast cancer. It is designed to target and deliver chemotherapy directly to cancer cells that have low levels of the HER2 protein, which is a common characteristic in certain types of breast cancer. The study aims to explore how well this medication works when used in combination with other anti-cancer agents, focusing on its safety, how the body processes it, and its ability to reduce tumor size.

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 hormone receptor status and HER2 status. It is a chronic condition that requires ongoing management to control the spread and alleviate symptoms.

Trial ID:
2023-505690-33-00
Protocol code:
D967JC00002
NCT ID:
NCT04556773
Trial Phase:
Human Pharmacology (Phase I) – Other

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