Active not recruitingPHASE3INTERVENTIONAL

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

This important study, called the CompassHER2 RD Trial, is investigating a new way to treat HER2-positive breast cancer that has a high chance of returning. Researchers are comparing two different approaches for people who still have some cancer left after their initial treatment. One group will receive trastuzumab emtansine (T-DM1), a smart drug that targets cancer cells. The other group will get T-DM1 along with another medicine called tucatinib. Tucatinib works by blocking signals that help cancer cells grow. The main goal is to find out if combining these two treatments is more effective at preventing the cancer from coming back, especially in the breast or other parts of the body, compared to T-DM1 by itself.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alliance for Clinical Trials in Oncology

Enrolment target

1,056

Start

02 Mar 2021

Estimated completion

31 May 2035

What is this study about?

This study is called the CompassHER2 RD Trial, and it's looking into new ways to help people with a type of breast cancer called HER2-positive. HER2-positive means that the cancer cells have too much of a certain protein called HER2, which can make the cancer grow and spread more quickly. This trial is specifically for people whose cancer is considered 'high risk,' meaning there's a greater chance it might return, even after their first round of treatment.

The main idea behind this study is to see if combining two different medicines can be more effective than using just one. One medicine is called trastuzumab emtansine, or T-DM1 for short. T-DM1 is a clever drug because it's like a 'smart bomb' – it has an antibody part (trastuzumab) that finds and sticks to the HER2 proteins on cancer cells, and it also carries a chemotherapy drug (DM1) directly to those cells to kill them. The other medicine in this study is tucatinib, which works by blocking certain signals inside cancer cells that they need to grow. Researchers want to know if adding tucatinib to T-DM1 will reduce the chances of the breast cancer coming back.

This study is focusing on how well these treatments prevent the cancer from returning, not just in the breast, but also in other parts of the body, including the brain. They will also be looking at overall health and quality of life for participants. By understanding if T-DM1 with tucatinib is better than T-DM1 alone, this research could help improve future treatments for people with high-risk HER2-positive breast cancer.

Key takeaways

This study evaluates T-DM1 with tucatinib versus T-DM1 alone for high-risk HER2-positive breast cancer.
It aims to prevent cancer from returning after initial treatment where some cancer remained.
T-DM1 targets HER2-positive cancer cells; tucatinib blocks cell growth.
Participants receive treatment cycles for about nine months, followed by long-term monitoring.
The study compares how well each approach stops cancer relapse, including spread to the brain.

Who may be eligible?

To be considered for this study, your breast cancer must be HER2-positive. This is determined by tests on your initial biopsy. You also need to have had some cancer left behind after your first breast cancer treatment, whether in the breast or lymph nodes. If your cancer is also hormone receptor-positive (meaning it's affected by hormones), you'd need to have residual cancer in your lymph nodes to be eligible.

There are also some details about the size and spread of your initial cancer. Your doctor will need to check your specific diagnosis carefully against the study's rules. For example, if your initial cancer was very small and hadn't spread to any lymph nodes, you might not be suitable for this study. The study also allows people who have cancer in both breasts at the same time.

Generally, those eligible are 18 years old or older, and the study is open to both men and women. The most important thing is that the initial tests on your cancer showed it was HER2-positive, and you still have some cancer cells found after your first treatment.

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.

Is your breast cancer HER2-positive?
Did you have some cancer remaining after your initial treatment (e.g., surgery)?
If your cancer is also hormone-positive, did it remain in your lymph nodes?
Are you 18 years old or older?
Are you able to take medicines by mouth and receive intravenous infusions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive T-DM1 given into a vein, and a dummy pill (placebo) taken by mouth. The other group will receive T-DM1 into a vein, along with tucatinib tablets taken by mouth. Both treatments are given over 21-day cycles, and you would continue for up to 14 cycles, which is about nine months, as long as the treatment is helping and manageable.

The T-DM1 infusion usually takes about 30-90 minutes. You'll take the tablets twice a day for 21 days within each cycle. Throughout the study, you'll have regular check-ups, potentially including examinations, blood tests, and scans to see how you're doing and if the treatment is working. You'll also be asked to fill out questionnaires about your quality of life.

After you finish the treatment part of the study, you'll continue to have follow-up appointments. These will be every six months for a total of 10 years to monitor your health and any long-term effects. The total duration of active treatment is about nine months, but the full follow-up lasts a decade.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by a medical team. For this study, you might benefit if combining T-DM1 and tucatinib is more effective at preventing your cancer from coming back than T-DM1 alone. However, there are also potential risks; you might experience side effects from the medications, some of which could be serious. The combination treatment might have different side effects than T-DM1 by itself. It's important to remember that treatments in clinical trials are still being investigated, and there's no guarantee of benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1176)

University of Alabama at Birmingham Cancer Center
Verified postcode
Birmingham, United States
Thomas Hospital
Verified postcode
Fairhope, United States
Mobile Infirmary Medical Center
Verified postcode
Mobile, United States
Anchorage Associates in Radiation Medicine
Verified postcode
Anchorage, United States
Anchorage Radiation Therapy Center
Verified postcode
Anchorage, United States
Alaska Breast Care and Surgery LLC
Verified postcode
Anchorage, United States
Alaska Oncology and Hematology LLC
Verified postcode
Anchorage, United States
Alaska Women's Cancer Care
Verified postcode
Anchorage, United States
Anchorage Oncology Centre
Verified postcode
Anchorage, United States
Katmai Oncology Group
Verified postcode
Anchorage, United States
Providence Alaska Medical Center
Verified postcode
Anchorage, United States
Fairbanks Memorial Hospital
Verified postcode
Fairbanks, United States

Common questions

What does 'HER2-positive breast cancer' mean?

It means the cancer cells have a lot of a protein called HER2, which can make the cancer grow quickly. Special treatments target this protein.

What is 'high risk' breast cancer?

High risk means there's a greater chance your cancer could come back, even after your first treatments.

What are T-DM1 and tucatinib?

T-DM1 is a smart drug that aims to deliver chemotherapy directly to cancer cells. Tucatinib is another medicine that helps stop cancer cells from growing.

Will I know which treatment I'm getting?

No, you'll be randomly assigned to one of two groups, and you won't know if you're getting tucatinib or the dummy pill (placebo) alongside T-DM1.

How often will I need to visit the hospital?

You'll have intravenous T-DM1 every 21 days for up to 14 cycles, plus regular check-ups and follow-up appointments for many years.