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A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Study testing Dato-DXd and Durvalumab for certain types of breast cancer.

Recruiting
18 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study tests new treatments for a type of breast cancer called **Triple-Negative** (TNBC) or **Hormone Receptor-low/HER2-negative** breast cancer. Neoadjuvant means treatment given before the main treatment, and adjuvant means treatment given after the main treatment. The study compares two sets of treatments. One group gets **Dato-DXd** and **Durvalumab**, and the other gets **Pembrolizumab** plus chemotherapy. Participants must be 18 or older and have confirmed Stage II or III breast cancer. The study checks if these new treatments help better than the current standard ones.

Doctors will look at how well the cancer shrinks (pCR) and how long patients stay free of cancer (EFS). To join, you should not have other major health issues like heart disease, uncontrolled infections, or other cancers. Pregnant or breastfeeding women cannot join.

  • Study Length: This is a long-term study, so participation will last several months.
  • Visits Needed: Regular doctor visits will be required for treatment and check-ups.
  • Risks and Benefits: Discuss potential side effects and benefits with your doctor.
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Study details
    Breast Cancer

NCT06112379

AstraZeneca

16 March 2025

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

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