Closed & in Follow up

PRIMETIME

Objectives

Eligibility for first phase (pre-op):

Age ≥60 (or ,60, postmenopausal and comorbidities implying high risk of radiotherapy toxicity )
Tumour pre-op assessed as ≤2cm, grade 1-2, ER +ve, PR tested, HER2 –ve or awaited, node negative
Breast conserving surgery planned

Eligibility for main study (assessed at post-op MDT):

Availability of Ki67 (performed centrally on diagnostic core)
Age ≥60 (or ,60, postmenopausal and comorbidities implying high risk of radiotherapy toxicity )
Breast conserving surgery with complete resection of tumour tissue (≥1 mm)
pT1/pN0/M0; tumours should be unifocal (associated DCIS is allowed, providing whole tumour size ≤2cm)
Node negative (ITCs in axillary nodes are allowed)
Grade 1 or 2 on excised tumour
ER positive according to local practice
PR status tested
HER2 negative according to local practice
Patient recommended for ≥5 years adjuvant endocrine therapy and willing to start and comply with endocrine therapy

Recruitment sites

64 sites opened to recruitment

Closed to recruitment 31/03/2022. Currently in follow-up.