Figure 2.

ADAPT Umbrella trial design. Patients are included in the trial based on the results of the diagnostic core biopsy and local pathology for histologically confirmed tumors. Based on the subtype classification, patients are allocated to the respective sub-trial and start subtype-specific induction therapy for three weeks. Central pathology assessment includes hormone receptors, HER2 and Ki-67. For HR+ tumors, an initial RS is determined by Oncotype DX®. Following three weeks of induction therapy, efficacy estimation is done using repeat core biopsy or surgical specimen (in case of adjuvant treatment; HR+/HER2- only). The ADAPT Umbrella comprises two sequential tumor samples and the three week subtype-specific induction therapy. Further subtype-specific therapy is subject to the ADAPT sub-trials.