Plain-English translation of NCT05812807 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
After chemotherapy combined with , some people with triple-negative breast cancer achieve a complete response — meaning scans and surgery show no remaining cancer. This trial is testing whether these patients can safely skip additional treatment after surgery, or whether continuing the medication reduces the chance of cancer returning. Half of participants will continue taking for 27 weeks, while the other half will have close observation only.
Immunotherapy drugs like can have side effects and are expensive. Doctors want to know whether patients whose cancers have completely disappeared still need this medication, or whether observation alone is equally safe and avoids unnecessary treatment burden.
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You will be randomly assigned to one of two groups: either receiving infusions every 3 or 6 weeks for 27 weeks, or having observation only with no additional medication. Both groups will have regular imaging (mammography, ultrasound, or MRI), blood draws, and tissue biopsies throughout the study. You'll complete quality-of-life questionnaires and be followed for recurrence and overall health. The study lasts about 27 weeks of active treatment or observation, with longer-term follow-up afterward.
AI-generated summary from trial data · Aug 19, 2026 · Not medical advice
United States