Trial Purpose

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (sac-TMT; MK-2870) in combination with pembrolizumab compared to treatment of physician’s choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sac-TMT plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sac-TMT plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

View full trial information on Clinicaltrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT06393374

When speaking to your doctor or clinical trial representative, please have the trial reference number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions

Triple-Negative Breast Cancer

Age Range

18+

Sex

All

About The Study

Trial Phase

Trial Phase 3

In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial start and end dates
  • Actual study start date June 24, 2024
  • Estimated primary completion date December 16, 2030
  • Estimated study completion date December 14, 2037

Trial Locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

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Contact our Trial Information Center

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NATIONAL TRIAL REFERENCE NUMBER

NCT06393374

When speaking to your doctor or clinical trial representative, please have the trial reference number available.

Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational treatment that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about