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Figure 3 | Trials

Figure 3

From: WSG ADAPT – adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial

Figure 3

ADAPT HR+/HER2- trial design. Patients with HR+/HER2- disease receive three weeks of endocrine induction therapy according to current AGO guidelines. After pathologic assessment patients are classified according to RS risk groups (low/intermediate/high risk of recurrence). Low-risk is defined as N0-1 RS ≤11 and will be allocated to adjuvant endocrine therapy alone. Definition of intermediate-risk is based on N0-1 and RS 12–25. Patients with early therapy response as measured by Ki-67post ≤10% also receive endocrine therapy only. Intermediate-risk patients with low therapy response and Ki-67post >10% are randomized to one of the two chemotherapy arms just like all high-risk patients, i.e., N2-3 or N0-1 and RS ≥26. Patients at high risk (pN ≥2 or RS ≥26) with clear need for chemotherapy may omit induction therapy and undergo immediate randomization.

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Trials

ISSN: 1745-6215