Table 1.

Design of Recent or Ongoing Adjuvant Bisphosphonate Trials in Breast Cancer Patients

Trial	Population	Design	Schedule	Bisphosphonate timing	Results
ABCSG-12[7]	Premenopausal HR+ Stage I–III breast cancer N = 1803	ZA vs control	4 mg IV every 6 mos for 3 yrs	Started at same time as endocrine therapy	HR = 0.64 for DFS in favor of ZA, p = 0.01
AZURE[8]	Stage II–III breast cancer N = 3360	ZA vs control	4 mg IV monthly for 6 mos, then every 3 mos for 8 doses, then every 6 months for 5 doses	Neoadjuvant arm: No more than 30 days after initiation of neoadjuvant therapy Adjuvant arm: No more than 60 days since prior definitive surgery	Accrual complete, results of neoadjuvant arm presented at SABCS 2008
Z-FAST ZO-FAST[9, 10] E-ZO-FAST	HR+ Stage I–III breast cancer N = 2193	ZA: immediate vs delayed	4 mg every 6 mos	Immediate arm: Started at same time as endocrine therapy Delayed arm: Started when significant BMD change or fracture	Accrual complete, 36 month followup presented at SABCS 2008
NSABP-B34[12]	Stage I–II breast cancer N = 3400	Clodronate vs placebo	1600 mg PO daily for 3 yrs	Randomized within 84 days of surgery	Accrual complete
GAIN [11]	Stage II–III breast cancer N > 3000	Ibandronate vs control	50 mg PO daily for 2 yrs		Accrual ongoing

HR+ = hormone-receptor positive

SABCS = San Antonio Breast Cancer Symposium

PO = per orum or by mouth

IV = intravenous