S2212 SHORTER ANTHRACYCLINE-FREE CHEMO IMMUNOTHERAPY ADAPTED TO PATHOLOGICAL RESPONSE IN EARLY TRIPLE NEGATIVE BREAST CANCER (SCARLET) A RANDOMIZED PHASE III STUDY

Brief description of study

This is a randomized Phase III trial comparing a standard neoadjuvant chemotherapy regimen to an experimental neoadjuvant chemotherapy regimen that omits AC therapy. Both arms receive pembrolizumab for one year. If participants in the experimental arm have residual disease after neoadjuvant therapy, then they may receive adjuvant therapy post-surgery at physician discretion. This is a parallel randomization open-label design with equal allocation to the two treatment groups: (1) standard neoadjuvant chemotherapy and (2) neoadjuvant chemotherapy without AC. Randomization will be stratified by nodal status (negative or positive).


Clinical Study Identifier: s23-01298
ClinicalTrials.gov Identifier: NCT05929768
Principal Investigator: Natalie Jill Klar.
Other Investigators: Yelena Novik, Maryann J Kwa, Nina D'Abreo, Marleen I Meyers, Ariel Karwat, Amanda Marie Talmadge, Danielle Seidman, Yan Fon Mei, Yael Simons, Nancy Chan, Caitlin Elizabeth Ryan, Anastasiya Apanasyuk, Alexander A Hindenburg, Ruth Oratz, Douglas K Marks.


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