Active not recruitingPHASE3INTERVENTIONAL

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

This research study is for people with HER2-positive breast cancer that has spread or is advanced and can't be removed by surgery. We are testing a new medicine called tucatinib. Participants will either receive tucatinib or a placebo (a dummy pill with no medicine) in addition to two other standard cancer drugs, trastuzumab and pertuzumab. Doctors and patients won't know who is getting which treatment. The main goal is to see if tucatinib improves treatment outcomes and to understand any side effects it might cause in combination with the other drugs. This is an important step in finding better ways to treat this type of breast cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

654

Start

07 Mar 2022

Estimated completion

28 Sep 2027

HER2 Positive Breast Cancer

What is this study about?

This study is all about finding better ways to treat a specific type of breast cancer called HER2-positive breast cancer. This cancer has too much of a protein called HER2, which helps cancer cells grow. When this type of cancer has spread to other parts of the body (this is called metastatic cancer) or is advanced and can't be removed with surgery, doctors are always looking for new and effective treatments.

The main idea behind this study is to see if a new drug, tucatinib, can help people more when added to treatments they already receive. All participants in this study will receive two well-known cancer drugs, trastuzumab and pertuzumab. These drugs are already used to treat HER2-positive breast cancer. On top of this, some people will also get tucatinib, while others will get a 'placebo.' A placebo looks exactly like tucatinib but doesn't contain any medicine.

By comparing the two groups – those who receive tucatinib plus the standard treatment, and those who receive a placebo plus the standard treatment – researchers can understand if tucatinib actually helps and what its side effects are. Taking part in a study like this helps us learn more about cancer and develop new medicines for the future.

Key takeaways

Tests a new medicine (tucatinib) for HER2-positive breast cancer.
Compares tucatinib with a dummy pill (placebo) alongside standard treatments.
For advanced or metastatic HER2-positive breast cancer.
Participants don't know if they get tucatinib or placebo.
Aims to find better treatments and understand side effects.

Who may be eligible?

This study is looking for people with HER2-positive breast cancer that has spread throughout the body (metastatic) or is advanced and can't be removed by surgery. You must have had 4 to 8 cycles of initial treatment with trastuzumab, pertuzumab, and another drug called a taxane, and your cancer should not have gotten worse during this time. Your doctors will need to confirm your cancer type and that it's HER2-positive.

There are also some important points about brain metastases, which are when the cancer spreads to the brain. You might still be able to join if you have no brain metastases, or if you have some but they aren't causing symptoms and haven't gotten worse since you started your initial treatment. If you've had brain metastases treated before, you can also be considered if they haven't gotten worse since then.

However, you cannot join if you have previously taken certain types of HER2-targeting drugs, including tucatinib itself, lapatinib, neratinib, or others, except in very specific situations. Your overall health and ability to perform daily activities will also be assessed by a doctor to ensure you are well enough for the study.

Quick self-check

Do you have HER2-positive breast cancer?
Has your cancer spread or is it advanced and cannot be removed by surgery?
Have you recently had 4-8 cycles of initial treatment with trastuzumab, pertuzumab, and a taxane, and your cancer hasn't gotten worse?
Are your brain metastases, if any, not causing symptoms or getting worse?
Have you not taken certain other HER2-targeting drugs before (like pyrotinib, lapatinib, neratinib, tucatinib, or afatinib)?
Are you generally well enough to manage daily activities?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. Neither you nor your doctor will know which group you are in. Both groups will receive trastuzumab and pertuzumab. You'll receive these medications either through a drip into your vein (intravenously) or as an injection under your skin (subcutaneously) every 21 days.

In addition to these, one group will receive tucatinib pills, and the other will receive placebo pills. You will take these pills by mouth, twice a day. The study involves regular visits to the clinic for treatments, check-ups, and tests to see how you're responding and to monitor for any side effects. This could include scans like MRI for your brain, blood tests, and physical examinations. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment (tucatinib) before it's widely available, and close monitoring of your health by a medical team. However, there are also potential risks, including side effects from tucatinib or the other study drugs, which can vary from person to person. It's important to understand that new treatments don't always work for everyone, and sometimes they don't work better than existing options. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (307)

Mayo Clinic Hospital
Phoenix, United States
Mayo Clinic
Scottsdale, United States
Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
Little Rock, United States
UCLA Hematology/Oncology - Beverly Hills
Beverly Hills, United States
UCLA Hematology/Oncology - Burbank
Burbank, United States
UCSD Medical Center - Encinitas
Encinitas, United States
Sulpizio Cardiovascular Center at UC San Diego Health
La Jolla, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, United States
UCSD Koman Family Outpatient Pavilion
La Jolla, United States
UCSD Perlman Medical Offices
La Jolla, United States
UC San Diego Moores Cancer Center
La Jolla, United States
UCLA Hematology/Oncology - Laguna Hills
Laguna Hills, United States

+295 more sites — see the official record for the full list.

Common questions

What is HER2-positive breast cancer?

It's a type of breast cancer that has too much of a protein called HER2, which can make the cancer grow faster.

What is a 'placebo'?

A placebo is a pill that looks like the study drug but doesn't contain any active medicine. It helps researchers compare the real drug's effects.

Why don't I know if I'm getting the drug or placebo?

This helps ensure the study results are fair and accurate, as knowing can sometimes influence how people feel or report symptoms.

What are trastuzumab and pertuzumab?

These are two standard medicines already used to treat HER2-positive breast cancer, often given together.

What does 'metastatic' mean?

It means the cancer has spread from where it started to other parts of the body.