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Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

Trying a new drug, Durvalumab, with usual chemo for breast cancer.

Recruiting
18 years and older
All
Phase 3

Study Overview: This research examines if adding an immunotherapy drug called durvalumab to the usual chemotherapy helps treat certain types of breast cancer better. Chemotherapy involves drugs like paclitaxel, cyclophosphamide, and doxorubicin that stop cancer cells from growing. Durvalumab is an immunotherapy that boosts the immune system to fight cancer cells. The study is for patients with stage II-III hormone receptor-positive, HER2-negative breast cancer.

  • Study Duration: Treatment lasts for several months, with follow-ups up to 10 years.
  • Visits and Procedures: Involves regular doctor visits, blood tests, mammograms, and possibly tissue samples.
  • Risks and Benefits: Potential side effects include fatigue and other chemotherapy-related symptoms. The goal is to improve survival rates and reduce cancer recurrence.

Eligibility: Participants should have specific types of breast cancer, be 18 years or older, and not have received prior treatments for their current cancer. They will need to provide tissue samples and undergo a MammaPrint test to qualify.

Considerations: Patients should discuss potential benefits and risks with their doctor to decide on participation. The study is investigational and supported by prior research suggesting improved outcomes for similar patients.

Study details
    Anatomic Stage II Breast Cancer AJCC v8
    Anatomic Stage III Breast Cancer AJCC v8
    HER2-Negative Breast Carcinoma
    Hormone Receptor-Positive Breast Carcinoma
    Localized Breast Carcinoma

NCT06058377

National Cancer Institute (NCI)

16 March 2025

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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.

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

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

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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