Radial margins must be equal to or greater than 1mm (see page 8 of protocol). However, where there is insufficient tissue to take a 1mm margin at the superficial or deep margin, these margins should be pathologically clear of tumour. Such a patient would be eligible, provided the surgeon has performed a full thickness excision right up to the subcutaneous fat and down to the pectoral fascia. If there is disease approaching, but not directly cut through at a margin, then the patient is eligible for PRIME.
Patients should be excluded if they have cut through disease at either the superficial or deep margins.
A minimum of 4 ipsilateral, lower axillary nodes must be sampled, unless a sentinel node biopsy is performed.
Patients with DCIS only are not eligible.
Patients with uni-focal invasive tumour surrounded by DCIS to a maximum area of involvement of 30mm are eligible providing the radial margins are clear (>=1mm) and superficial and deep margins are not directly cut through, as above.
Multiple tumours in either the same or contralateral breast render the patient ineligible.
The following conditions are acceptable, provided all other eligibility criteria have been met.
From the point of view of the trial, we have no limit set on this period. However, it has been generally accepted that radiotherapy has to begin within 20 weeks of surgery to be effective.
As more queries come in, this page will be updated.