Between March 1990 and May 1993 seventy three patients with previously untreated breast cancer, Stage III or IV without osseal metastases were randomized to sodium clodronate 1600 mg daily p.o.(arm 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 therapy (less than 2 months). Bone metastases developed in 30% of patients in arm 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 appeared in 48% patients in arm A and in 48% patients in arm B. Time to development of non-bone metastases was 20 months in arm A and 16 months in arm B. Five-year survival was 41% in arm A and 39% in arm B. There were no significant differences between the treated and control arms.

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