Image

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

Exploring new treatment options for high-risk HER2-positive breast cancer.

Recruiting
18 years and older
All
Phase 3

This study investigates if a combination of two drugs, **T-DM1** and **tucatinib**, can better prevent the return of **HER2-positive breast cancer** than T-DM1 alone. T-DM1 combines a targeted therapy, trastuzumab, with a chemotherapy drug, DM1. Trastuzumab targets specific cancer cell markers called HER2 receptors. Tucatinib is a drug that may block certain enzymes to stop cancer cell growth. Patients will receive treatments every 21 days for up to 14 cycles unless the disease progresses or severe side effects occur. After treatment, participants are monitored for up to 10 years.

  • Participants may need to visit the clinic every 21 days for treatments.
  • The trial includes follow-up visits for 10 years to monitor health.
  • Potential side effects may occur; discuss risks with your doctor.
Study details
    Anatomic Stage IA Breast Cancer AJCC V8
    Anatomic Stage II Breast Cancer AJCC V8
    Anatomic Stage IIA Breast Cancer AJCC V8
    Anatomic Stage IIB Breast Cancer AJCC V8
    Anatomic Stage III Breast Cancer AJCC V8
    Anatomic Stage IIIA Breast Cancer AJCC V8
    Anatomic Stage IIIB Breast Cancer AJCC V8
    Anatomic Stage IIIC Breast Cancer AJCC V8
    HER2 Positive Breast Carcinoma
    Invasive Breast Carcinoma
    Multifocal Breast Carcinoma
    Prognostic Stage I Breast Cancer AJCC V8
    Prognostic Stage IA Breast Cancer AJCC V8
    Prognostic Stage IB Breast Cancer AJCC V8
    Prognostic Stage II Breast Cancer AJCC V8
    Prognostic Stage IIA Breast Cancer AJCC V8
    Prognostic Stage IIB Breast Cancer AJCC V8
    Prognostic Stage III Breast Cancer AJCC V8
    Prognostic Stage IIIA Breast Cancer AJCC V8
    Prognostic Stage IIIB Breast Cancer AJCC V8
    Prognostic Stage IIIC Breast Cancer AJCC V8
    Synchronous Bilateral Breast Carcinoma

NCT04457596

Alliance for Clinical Trials in Oncology

1 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.