What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Sacituzumab tirumotecan, Pembrolizumab, or Rescue Medication. The registry lists allocation as randomized. Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
They plan to enroll about 2,400 people at 335 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
Interventions: Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication, Carboplatin, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide, Capecitabine, Olaparib
Primary outcome (registry wording): Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery