Study on the Safety and Effects of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2-positive Metastatic 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 excess of a protein called HER2. The study will explore the effects of a treatment called trastuzumab deruxtecan (also known as T-DXd) when used in combination with other cancer-fighting drugs. These additional drugs include pertuzumab, durvalumab (also known as IMFINZI), and infliximab (known as Inflectra), among others. The purpose of the study is to assess the safety, tolerability, and effectiveness of these drug combinations in treating this type of breast cancer.

The study will be conducted in two main parts. In the first part, researchers will determine the best dose of the drug combinations to use. This is known as the dose-finding phase. In the second part, the study will expand to include more patients to further evaluate the safety and effectiveness of the treatment at the determined dose. This is called the dose-expansion phase. The study will include patients who have already received treatment for their cancer as well as those who have not yet been treated for advanced or metastatic disease.

Throughout the study, participants will receive the treatments either orally or through an infusion, which is a method of delivering medication directly into the bloodstream. The study aims to provide valuable information on how these drug combinations can help manage HER2-positive Metastatic Breast Cancer, including patients with brain metastases, which are cancer cells that have spread to the brain. The study is expected to continue until 2025, with recruitment starting in 2024.

1 joining the study

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

The cancer must be HER2-positive and either advanced or metastatic, with specific hormone receptor status.

2 initial assessment

An initial assessment is conducted to gather a tumor sample for biomarker analysis.

The patient’s performance status is evaluated to ensure it meets the required level.

3 treatment phase 1

The first part of the treatment involves finding the right dose of trastuzumab deruxtecan (T-DXd) in combination with other medications.

Medications used may include mycophenolate mofetil (oral), pertuzumab, durvalumab, and infliximab (all intravenous).

The focus is on assessing safety and determining the recommended dose for the next phase.

4 treatment phase 2

In the second part, the recommended dose from phase 1 is used to further evaluate safety and effectiveness.

This phase may involve T-DXd alone or in combination with other medications.

5 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to track any side effects and the overall response to treatment.

The study aims to measure outcomes such as progression-free survival and overall survival.

Who Can Join the Study?

Patients must be at least 18 years old.
Must have breast cancer that is either advanced (cannot be removed by surgery) or metastatic (has spread to other parts of the body).
The cancer must be HER2-positive, which means it has a specific protein that promotes cancer growth. This must be confirmed by a test on a tumor sample from when the cancer spread.
The cancer can be either hormone receptor-positive (responds to hormones like estrogen or progesterone) or negative.
Must have a sufficient tumor sample from when the cancer spread for testing purposes.
Must have an ECOG Performance Status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
For Part 1 of the study: The disease must have worsened after the last treatment, and the patient must have had at least one previous treatment for metastatic cancer.
For Part 2 (Modules 0 – 5): No previous treatments for advanced or metastatic cancer are allowed.
For Part 2 (Modules 6 and 7): Zero or one previous treatments for advanced or metastatic cancer are allowed.
For brain involvement (CNS Inclusion):

Modules 0 – 5: Patients must have no brain metastases or stable brain metastases.
Modules 6 and 7: Patients can have untreated brain metastases that do not need local treatment or previously treated brain metastases that have worsened since the last local treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer that is not HER2-positive Metastatic Breast Cancer cannot participate. HER2-positive means the cancer cells have more of a protein called HER2, which can make the cancer grow faster.
Patients who have already received treatment for their advanced or metastatic breast cancer are not eligible for Part 2 of the study. Metastatic means the cancer has spread to other parts of the body.
Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to safely tolerate the study medications or have other health conditions that could interfere with the study treatment are excluded.
Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Del Mar	Barcelona	Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Islwhbkd Cuovyu Dgzfhfswktongixxr	L'hospitalet De Llobregat	Spain
Aksxzmp Uvmkc Swrikwypu Lcvjlx Dl Bhafhzy	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	24.04.2024
Italy	Not recruiting	24.04.2024
Poland	Not recruiting	24.04.2024
Spain	Not recruiting	24.04.2024

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan (T-DXd) is a medication used in this clinical trial to treat patients with HER2-positive metastatic breast cancer. It is designed to target and deliver chemotherapy directly to cancer cells, helping to reduce the size of tumors and slow the progression of the disease. The study aims to explore the safety and effectiveness of T-DXd when used alone and in combination with other anti-cancer agents.

Investigated diseases:

HER2 positive breast cancer

HER2-positive Metastatic Breast Cancer – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It is considered metastatic when the cancer has spread beyond the breast to other parts of the body. The disease often progresses through stages, starting from localized breast tissue and potentially moving to lymph nodes and distant organs. HER2-positive cancers tend to grow and spread more aggressively than other types of breast cancer. The progression can vary, with some patients experiencing rapid advancement, while others may have a slower course. Understanding the HER2 status is crucial for determining the appropriate treatment approach.

Trial ID:

2023-505309-18-00

Protocol code:

DESTINY-Breast07

NCT ID:

NCT04538742

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2-positive Metastatic Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?