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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 new treatment for Stage I breast cancer patients.

Recruiting
18 years and older
All
Phase 2

This study is for people with a certain type of breast cancer, called HER2-positive, hormone receptor-positive breast cancer. "HER2-positive" means the cancer has a protein that makes cancer cells grow, and "hormone receptor-positive" means the cancer grows because of hormones like estrogen or progesterone. After surgery, participants will receive two types of treatments: a combination of drugs called PHESGO (trastuzumab and pertuzumab) and hormonal therapy. PHESGO is given as an injection under the skin.

Here are some key points about the study:

  • Participants will receive PHESGO for 1 year and will continue hormonal therapy for about 5 years.
  • The study involves regular doctor visits, lab tests, and answering questions about health.
  • 375 people are expected to join, and the study tests the safety and effectiveness of the treatment.

To join, participants must meet specific requirements, like having had surgery to remove the tumor, not having had certain treatments before, and being able to follow study instructions. The study aims to see if this combination of treatments helps improve outcomes for people with this type of breast cancer.

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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