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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/NSABP B-63)

We’re studying new treatments for certain breast cancer patients after surgery.

Recruiting
18 years and older
All
Phase 3

This study looks at using two experimental medicines, *sacituzumab govitecan-hziy (SG)* and *pembrolizumab*, for treating people with **Triple Negative Breast Cancer (TNBC)** after surgery. TNBC is a type of breast cancer that does not have certain receptors (like estrogen, progesterone, and HER2). The study compares if these medicines work better than the usual treatments doctors choose, which might include *pembrolizumab* or *pembrolizumab* plus another medicine called *capecitabine*.

Eligibility: Participants must be over 18, have had surgery, and still have some cancer left. They also need to have had proper radiation treatment and be in good health otherwise. People with stage IV breast cancer or previous breast cancer will not be included.

  • Length of Study: The time commitment for participation is not specified.
  • Visits Needed: Participants may need to visit the study site regularly for treatments and check-ups.
  • Possible Risks: Risks include side effects from the experimental drugs, which will be monitored closely by the study team.

Participants should discuss with their doctor if this study is suitable for them.

Study details
    Triple Negative Breast Cancer

NCT05633654

Gilead Sciences

2 February 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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