Background: Disseminated tumour cells can remain dormant in the bone marrow for years prior to subsequent activation and the development of overt metastases. Bisphosphonates (BP) have profound effects on bone physiology and could potentially modify the metastatic disease process. Variable outcomes in terms of disease recurrence have been reported, with efficacy apparently influenced by menopausal status. Methods: We sought individual patient data for meta-analysis from 41 randomised trials that compared BP to no BP (placebo or open control). Primary outcomes were time to recurrence, time to first distant recurrence and breast cancer mortality. Predefined subgroup comparisons were of type of BP (amino-/non-amino), duration and schedule of BP treatment, menopausal status, age, ER status, concomitant chemotherapy and site of distant recurrence (bone/other). Results: Data on 17,751 women (75% of 23,573 randomised in relevant trials) have so far been received, with around 3,300 breast cancer recurrences and 2,500 deaths. Effects on breast cancer mortality, recurrence and bone metastases for 17,016 women in the locked database and for 10,540 who were postmenopausal are shown below. Reductions in bone recurrence for postmenopausal women were similar irrespective of bisphosphonate type, treatment schedule, ER status, nodal involvement or use of concomitant chemotherapy. There were no improvements in bone (RR = 1.00, 2p = 0.97) or other recurrence for premenopausal women. Adjuvant bisphosphonates also reduced bone fractures (RR = 0.83, 2p = 0.009). Conclusion: Adjuvant bisphosphonates reduce bone recurrences and improve breast cancer survival in postmenopausal but not premenopausal women. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S4-07.