A012103: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Inclusion:

• TNBC 
• Clinical Stage II or III at diagnosis (T1cN1-2 or T2-4N0-2)
• No residual disease after neoadjuvant tx; Residual DCIS is allowed.
• If invasive disease was present in both breasts, participation in study is permitted as long as elig criteria are met for both tumors/breasts
• Received neoadjuvant chemo + pembrolizumab for a minimum of 6 cycles
• No more than 12 weeks between the completion of final surgery and randomization
• Adjuvant RT can be given on study, however it is recommended to complete adjuvant radiation prior to registration.  If radiation is given on study, it is encouraged to be given concurrently with pembro if pt is on the pembro arm.
• Adjuvant pembro is discouraged, but is allowed up to 6 weeks (#2 Q3 week doses or #1 Q6 week dose) post-operative and completed prior to registration