AuthorisedTherapeutic confirmatory (Phase III)Interventional

A randomized phase III study comparing trastuzumab, pertuzumab plus docetaxel (TPD) followed by 3 cycles of chemotherapy to the current standard regimen as the treatments of early HER2-positive breast cancer

This study is for women with an early type of breast cancer called HER2-positive. Doctors are comparing a new treatment plan to the current standard treatment. The new plan involves a specific combination of medicines: trastuzumab, pertuzumab (also known as Perjeta), and docetaxel, followed by more chemotherapy. The main goal is to find out if this new approach can help prevent the cancer from returning for longer. Researchers will also look at how long people live, if the cancer spreads to other parts of the body, and how the treatments affect the heart and overall quality of life. This is a large study (Phase III) to confirm if the new treatment is better and safer.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

HUS-Yhtymae

Enrolment target

520

Start

25 Apr 2024

breast cancer

What is this study about?

This research study is looking for women who have been diagnosed with early HER2-positive breast cancer. This is a type of breast cancer where the cancer cells have a lot of a protein called HER2, which helps them grow. The study wants to compare a new treatment approach against the treatment that doctors currently consider standard.

The new treatment approach involves a combination of medicines: trastuzumab, pertuzumab (which you might hear called Perjeta), and docetaxel. After receiving these medicines, patients will then have three more cycles of chemotherapy. The main purpose of this study is to see if this new combination of medicines is better at stopping the cancer from coming back or spreading to other parts of the body compared to the standard treatment.

Researchers will also be closely watching other important things, like how long people live, if the cancer spreads far away from the original site, and how these treatments affect the heart (specifically, how well the left side of the heart pumps blood). They will also be tracking any side effects and how the treatments impact your overall quality of life. This is a big, important study (called a Phase III trial) meant to confirm if this new treatment can become a better option for people with HER2-positive breast cancer.

Key takeaways

This study compares a new treatment combo for early HER2-positive breast cancer.
It aims to see if the new treatment prevents cancer from returning better.
The new treatment includes Perjeta, alongside other breast cancer medicines.
Researchers will also check heart health and quality of life.
This is a large, important study (Phase III) to guide future treatments.

Who may be eligible?

This study is open to women who are 18 years old or older. There is no upper age limit for taking part.

To be eligible, you must have been diagnosed with early HER2-positive breast cancer. This means the cancer is in its initial stages and has specific characteristics (HER2-positive).

Your study doctor will discuss all the specific requirements with you to make sure this particular trial is right for your situation and health.

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 an adult woman (18 years or older)?
Have you been diagnosed with early-stage breast cancer?
Has your breast cancer been identified as 'HER2-positive'?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to either the new treatment group or the standard treatment group. You won't get to choose which group you are in, as this is decided randomly, like flipping a coin. You will receive infusions of the study medications, which means they will be given through a drip into your vein. The specific schedule and number of visits will depend on which treatment group you are in. You will have regular appointments for check-ups, blood tests, heart scans (to check your left ventricle ejection fraction), and to discuss any side effects you might be experiencing. We will also ask you to complete questionnaires about your quality of life. The doctors and nurses will explain how long your treatment and follow-up will last, which will vary based on your treatment plan and how you respond.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than standard care, or you might help doctors learn more about the best ways to treat your condition, which could help future patients. However, there's always a chance the new treatment might not work as well, or it might cause unexpected side effects that could be different or more severe than the standard treatment. The healthcare team will monitor you closely for any side effects and discuss all known risks with you before you agree to participate. Remember, your participation is completely voluntary, and you can change your mind and withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Sweden
—
Unverified
Finland

Common questions

What does 'HER2-positive' mean?

HER2-positive means your breast cancer cells have too much of a protein called HER2, which helps them grow. Specific treatments can target this protein.

What is Perjeta?

Perjeta is a brand name for a medicine called pertuzumab, which is used to treat HER2-positive breast cancer. It works by blocking messages that tell cancer cells to grow.

What is a 'Phase III' study?

A Phase III study is a large research study that compares a new treatment to the standard treatment. It's done to confirm if the new treatment is better and safe enough to be widely used.

Will I get to choose my treatment?

No, in this study, the treatment you receive will be chosen by chance, like drawing lots. This helps make the study fair and scientific.

How long will I be in the study?

The exact length of your participation will depend on your treatment plan and how you respond, but the doctors will give you a clear timeline.