Adjuvant clodronate therapy in patients with locally advanced breast cancer - long term results of a double blind randomized trial

Between March 1990 and May 1993 seventy three patients with previously untr eated breast cancer, Stage III or IV without osseal metastases were randomi zed to sodium clodronate 1600 mg daily p.o.(ann A = 37 patients) or placebo (arm B = 36 patients) over 2 years, additionally to standard therapy. Ten patients were not evaluable for response because of short duration of thera py (less than 2 months). Bone metastases developed in 30% of patients in an n A and 23% patients in arm B. Median time to appearance of bone metastases was 13 months in arm A and 28 months in arm B. Non-bone metastases appeare d in 48% patients in arm A and in 48% patients in arm B. Time to developmen t of non-bone metastases was 20 months in arm A and 16 months in arm B. Fiv e-year survival was 41% in arm A and 39% in arm B. There were no significan t differences between the treated and control arms.