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A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Study on therapy for stage I hormone and HER2-positive breast cancer.

Recruiting
18 years and older
All
Phase 2

This research study is for people with a type of breast cancer called hormone receptor-positive, HER2-positive. This means the cancer grows from hormones and a protein called HER2. After surgery, the study uses two medicines, trastuzumab and pertuzumab, which are given together as one injection called PHESGO. These medicines are special proteins that help the body fight cancer. They are already approved by the U.S. Food and Drug Administration (FDA) for treating this type of cancer.

The study also uses hormonal therapy to lower the hormones that make cancer grow. Participants will receive PHESGO treatment for 1 year and hormonal therapy for about 5 years. The study checks if this combination works well and is safe.

  • The study lasts about 5 years, with PHESGO treatment for 1 year.
  • 375 people are expected to join this study.
  • Participants must have had surgery to remove the cancer.

If you join, you will have medical tests and follow-up visits. It's important to be willing to stop using hormonal birth control and use other forms of contraception during the study. If you meet the eligibility criteria and are interested, you can talk to your doctor about participating.

Study details
    HER2-positive Breast Cancer
    Invasive Carcinoma of the Breast
    Breast Cancer
    Node Negative Breast Cancer
    Micrometastasis Breast Cancer
    Hormone Receptor Positive Breast Cancer

NCT04569747

Dana-Farber Cancer Institute

13 December 2024

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.

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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.
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