Trial Information

A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer

OBJECTIVES:

- Compare the changes in bone mineral density (BMD) and bone turnover that occur in
premenopausal women with resected early stage breast cancer during and after 6 months
of adjuvant chemotherapy.

- Determine the factors that predict bone loss during chemotherapy, particularly
induction of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and
baseline BMD, in these patients.

- Determine whether zoledronate prevents bone loss in these patients when given during
and after adjuvant chemotherapy.

- Determine the effect of zoledronate on markers of bone turnover in these patients
during and after adjuvant chemotherapy.

- Determine whether the effect on markers of bone turnover predicts response to
zoledronate in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to estrogen receptor status (positive vs negative), progesterone
receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive zoledronate IV over 15 minutes on day 1.

- Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment
repeats every 3 months for up to 4 courses in the absence of disease progression.
Patients also receive calcium and cholecalciferol (vitamin D) supplements daily.

Quality of life is assessed at baseline and at 6 and 12 months.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study.