Active not recruitingPHASE2INTERVENTIONAL

PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

This study, called DEMETHER, is for people with HER2-positive breast cancer that has either come back in the local area and can't be removed with surgery, or has spread to other parts of the body (metastatic). It's a two-stage approach. First, participants will receive a drug called trastuzumab deruxtecan (T-DXd) for six cycles. After this initial treatment, they will then switch to a combination medicine called PHESGO for ongoing treatment. Researchers want to see how effective this treatment plan is in stopping the cancer from growing and how long people live. This is a Phase II study, meaning researchers are looking at how well the new treatment works and if it's safe for patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

MedSIR

Enrolment target

165

Start

22 Jul 2024

Estimated completion

01 Jun 2029

HER2-positive Breast Cancer

What is this study about?

This study, called DEMETHER, is exploring a new way to treat a specific type of breast cancer known as HER2-positive breast cancer. This is when cancer cells have too much of a protein called HER2, which helps them grow. The study focuses on situations where the cancer has either returned locally and can't be surgically removed, or has spread to other parts of the body.

The treatment has two main parts. First, participants will receive a medicine called trastuzumab deruxtecan (often shortened to T-DXd) for about six cycles. This medicine is designed to target the HER2 protein on cancer cells. After these initial cycles, if the treatment is tolerated, participants will switch to a different medicine combination called PHESGO. PHESGO is a combination of two drugs, trastuzumab and pertuzumab, given as an injection under the skin rather than through a drip. This second phase is considered the 'maintenance' part of the treatment, meaning it aims to keep the cancer under control over a longer period.

The main goal of this study is to find out if this two-step treatment plan is effective. Specifically, researchers want to see how many people are still free of cancer growth after one year, and how many are still alive after three years. By carefully observing participants, the researchers hope to gather important information that could help improve future treatments for HER2-positive breast cancer.

Key takeaways

This study is for HER2-positive breast cancer that has spread or returned locally.
It tests a two-step treatment: T-DXd followed by PHESGO.
It aims to see how well the treatment prevents cancer growth and improves survival.
Participants will have regular check-ups, scans, and blood tests.
The treatment involves initial cycles then ongoing maintenance therapy.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be 18 years or older and generally in good health, meaning you can carry out most daily activities with ease. Your doctor will check your overall health and confirm that your breast cancer is HER2-positive and has either come back locally and can't be removed by surgery, or has spread to other parts of your body.

It's important that you haven't received chemotherapy or other HER2-targeted treatments for advanced or metastatic breast cancer before starting this study. However, you might be eligible if you've only had hormone therapy for metastatic breast cancer, or if you had chemotherapy or HER2-targeted therapy in the past for early-stage breast cancer, as long as it's been more than 12 months since you finished that treatment and before your cancer became advanced or metastatic.

The study also needs a small sample of your cancer tissue to confirm its HER2 status. This might be from a past biopsy or surgery, or if that's not available, you might need a new biopsy. You also need to be able to fully understand what the study involves and agree to take part by signing a consent form.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have HER2-positive breast cancer that has spread or come back locally and can't be removed by surgery?
Have you not had chemotherapy or HER2-targeted treatment for advanced breast cancer before?
Are you generally well and able to manage most daily activities?
Are you able to provide a sample of your cancer tissue for testing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive the T-DXd treatment for six cycles. Each cycle involves specific appointments to receive the medication. After these initial six cycles, if the treatment is suitable for you, you will then switch to the PHESGO medicine, which is given as an injection under the skin. You will continue with PHESGO for as long as it works for you, or until three years (36 months) have passed since you started the T-DXd treatment, or if you need to stop for any other reason.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is working. This is to ensure your safety and track any changes in your cancer. If you stop the study treatment for any reason, you'll have a final safety check-up about a month later. After this, the study team will keep in touch with you every three months to see how you're doing and if you've started any new cancer treatments. They will continue to follow up until the end of the study or if you choose to stop.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. The potential benefit of joining this study is that you would be among the first to receive this specific two-stage treatment approach for HER2-positive breast cancer, which might be effective in controlling your cancer. However, there's no guarantee it will work for everyone, and it might not be better than existing treatments. All medicines can have side effects, and both T-DXd and PHESGO have known side effects, which your doctor will explain to you in detail. There might also be side effects that are not yet known. You will be closely monitored for any reactions. It's your right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (36)

Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Northwell Health
Verified postcode
New York, United States
Institute Paoli Calmettes
Verified postcode
Marseille, France
Hopital Europeen Georges Pompidou
Verified postcode
Paris, France
Hôpital Tenon AP-HP
Verified postcode
Paris, France
Marienhospital Bottrop GmbH Klinik für Gynäkologie und Geburtshilfe
Verified postcode
Bottrop, Germany
Kliniken Essen Mitte
Verified postcode
Essen, Germany
Mammazentrum HH
Verified postcode
Hamburg, Germany
Klinikum der Universität München
Verified postcode
München, Germany
Humanitas Gavazzeni
Verified postcode
Bergamo, Italy
Instituto Europeo di Oncologia
Verified postcode
Milan, Italy
University Hospital Maggiore della Carita
Verified postcode
Novara, Italy

Common questions

What type of breast cancer is this study for?

This study is specifically for HER2-positive breast cancer that has come back locally or spread to other parts of the body.

What is HER2-positive breast cancer?

This means your cancer cells have too much of a protein called HER2, which helps them grow.

What are the medicines involved?

The study uses two main treatments: T-DXd (trastuzumab deruxtecan) first, followed by PHESGO (a combination of trastuzumab and pertuzumab).

How long does the treatment last?

The T-DXd part lasts for about six cycles. The PHESGO part can continue for up to three years, or as long as it's working well for you.

Will I have to pay to be in the study?

No, participating in the clinical trial itself, including the study drugs and related medical appointments, is typically provided at no cost to you.