PRIMETIME

Updated Inclusion Criteria
 

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

57/60 open and recruiting

Timeline

Completing recruitment: 18th May 2021

Further Information
 

For further information about this trial please contact primetime-icrctsu@icr.ac.uk or on 0208 7224157

ICR website

Cancer Research UK website