NoELA_No Endocrine therapy in small HR+ HER2- low relapse risk Luminal A early breast cancer, a single-arm de-escalation trial

Condition studied

Postmenopausal patients with small (pT1a-b pN0) hormone receptor positive (HR⁺) and HER2 negative (HER2⁻) early breast cancer with a Luminal A phenotype and at low risk of recurrence.

Investigational medicinal product(s)

Eligibility

Primary endpoint

Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., JCO 2021)

Endpoint detail

RFI of participants treated with adjuvant hormone therapy in the CANTO study, Incidence of Ipsilateral DCIS, Contralateral DCIS, Invasive contralateral breast cancer at 5, 8 and 10 years*, Distant disease free survival (DDFS) and relapse free survival (RFS) rates at 5, 8, 10 years and overall survival (OS) at 5, 10 years * (RFI, DDFS, RFS and OS defined as per standardized STEEP v2.0 criteria), EORTC QLQC30 and EORTC QLQ-BR42, HADS questionnaires, Bone-related events and osteopenia/osteoporosis diagnosis, dyslipidemia (hypercholesterolemia and hypertriglyceridemia) and cardiovascular events (myocardial infarction, stroke, and thromboembolic events), as per CTCAE v6.0.