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A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Comparing treatments for certain breast cancer after initial therapy.

Recruiting
18-130 years
All
Phase 3

This study is for adults with stage I-III triple-negative breast cancer (TNBC) who didn't have a complete response after initial therapy. Triple-negative breast cancer (TNBC) is a type of breast cancer that doesn't have three common things found in most breast cancers, making it harder to treat. The study checks how well a new treatment, Dato-DXd, works alone or with a drug named durvalumab, against standard treatments known as ICT (investigator's choice therapy). ICT often includes drugs like capecitabine and pembrolizumab. The main aim is to see if Dato-DXd can help better than ICT.

  • The study requires participants to be 18 years or older and have some cancer left after surgery.
  • Eligible participants must not have had any previous breast cancer that came back or spread to other parts of the body.
  • Participants should not have any other uncontrolled health issues or severe allergies to the study drugs.

People who join might need to provide a tumor sample and take part in scans and tests. The study is international, meaning people from different countries can join. There are no emojis in this study summary.

Study details
    Breast Cancer

NCT05629585

AstraZeneca

6 January 2025

Step 1 Get in touch with the nearest study center
Entire USA
Results (undefined sites found)
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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.
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