PRIMETIME


PRIMETIME LogoOverview

 

PRIMETIME: Post-operative avoidance of radiotherapy: biomarker selection of women categorised to be in a very low risk group by IHC4+C.

PRIMETIME is a prospective study of biomarker directed treatment that is open to all centres treating breast cancer across the UK. The primary aim of the trial is to determine the safety of breast conserving surgery alone (omitting radiotherapy) in low risk ER positive early breast cancer.


Aims

 

The primary aim of the PRIMETIME trial is to determine the safety of breast conserving surgery alone - omitting radiotherapy - in low risk ER positive early breast cancer patients. The primary outcome is to assess the risk of ipsilateral invasive breast disease by five years following omission of postoperative breast radiotherapy, and the secondary outcomes following omission of radiotherapy include:

  • ipsilateral breast disease by 10 years
  • regional and distant relapse by 5 and 10 years
  • ipsilateral breast second primary cancer by 5 and 10 years
  • contralateral breast second primary cancer by 5 and 10 years
  • overall survival
  • breast cancer specific survival
  • overall invasive disease free survival

To confirm viability of collecting cancer outcomes via record linkage with the data collected routinely through NCRAS’s Cancer Analysis System and other informative UK cancer registries.


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 <3cm, grade 1-2, ER +ve, PR+ve, 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)
  • AJCC staging of pT1/pN0/M0 (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 positive according to local practice
  • HER2 negative according to local practice
  • Patient recommended for ≥5 years adjuvant endocrine therapy and willing to start and comply with endocrine therapy

Further information

 

For further information about this trial please contact primteimte-icrtsu@icr.ac.uk or on 0208 722 4054. You can also contact Natalie Atkins, Trial Manager, using the details below.

Natalie Atkins, PRIMETIME Trial manager

ICR Clinical Trials & Statistics Unit (ICR‐CTSU),

Division of Clinical Studies,The Institute of Cancer Research,

Sir Richard Doll Building,

Cotswold Road,

Surrey

SM2 5NG