ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC.
ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).
absolute neutrophil count ≥ 1.5 × 109/L,
platelets ≥ 100 × 109/L,
estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula,
INR ≤ 1.5,
1. Non-operable breast cancer including inflammatory breast cancer
cT1a/b, cN0 breast cancer
Any previous history of invasive breast cancer
Primary malignancies within 5 years, with the exception of
7
Treatment groupsSee each treatment group below.
West German Study Group
Lead sponsor
AstraZeneca
Collaborator