Bone Marrow Micrometeseses In Primary Breast Cancer – MR500

Identification of women who are at high risk of relapse after complete excision of the primary breast cancer. The presence of micormetastases may be assosicated with prognostic factors such as lymph node involvement and large tumour size and also with early disease recurrence.

Attempts to follow-up via original centres became problematic as the time from diagnosis increases and patients are discharged from routine follow-up. ICR use the requested data to link with trial data reported on CRFs to allow survival analyses to be conducted.

The aim of the Micormetastases study was to investigate the relationship between the presence of micrometastases at the time of diagnosis on long-term relapse-free and overall survival, and to determine whether this is an independent prognostic factor or related to other factors such as lymph node involvement and large tumour size

The cohort is already flagged at the HSCIC and ICR continue to require information on deaths and exits from the system. Death notifications should include date of death and cause of death.

Standard statistical methods for survival analysis will be used to investigate overall and relapse free survival, including (but not limited to) Kaplan-Meier plots, logrank tests and Cox PH Models.

Main results from the study and results of median long term follow-up effects have already been published (Br Med J, (6606): 1093-1096; Lancet, 354:197-202).

Analysis is ongoing with the aim of submitting for publication in peer-reviewed journals. Patients will not be identifiable and tables will be aggregated by randomised treatment group. Cells within aggregates will not allow identification of individual information.

Not stated in the register.

Not stated in the register.