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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Researching treatments for patients with triple-negative breast cancer after surgery.

Recruiting
18 years and older
All
Phase 3

This study investigates if the combination of two drugs, **sacituzumab govitecan-hziy (SG)** and **pembrolizumab**, is safe and effective for treating **triple negative breast cancer (TNBC)**. TNBC is a type of breast cancer that does not have certain receptors like estrogen, progesterone, or HER2. Participants in the study must be over 18, have had surgery to remove visible cancer, and still have some cancer remaining. The study compares this combination treatment with the treatment chosen by a doctor, which may include pembrolizumab alone or with another drug called **capecitabine**. Participants must have good organ function, have recovered from surgery, and not have stage IV cancer or specific heart problems.

  • This study requires participants to have a history of surgery and certain pre-study treatments.
  • Participants will need to provide tissue samples for analysis.
  • There are specific medical conditions and past treatments that may disqualify participation.
Study details
    Triple Negative Breast Cancer

NCT05633654

Gilead Sciences

27 April 2025

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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