Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

Herbert Irving Comprehensive Cancer Center120 enrolled

Overview

RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Breast Cancer Osteoporosis

Interventions

zoledronic acidDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of localized breast cancer * Stage I or II (T1-3, N0-2, M0) * Planned adjuvant chemotherapy (after surgery) of at least 6 months in duration * Hormone receptor status: * Estrogen receptor and progesterone receptor status known PATIENT CHARACTERISTICS: Age * 18 to 50 Sex * Female Menopausal status * Premenopausal or perimenopausal Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine less than 2 mg/dL Other * No T score of less than 2.0 on bone mineral density (BMD) * No fragility fracture * No lumbar spine anatomy that would preclude accurate BMD measurement of a minimum of 3 lumbar vertebrae * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics Other * At least 1 month since prior calcitonin * At least 12 months since prior bisphosphonates given for more than 1 month duration * No concurrent fluoride therapy (10 mg/day or more) * No concurrent enrollment in another experimental drug study

Locations (3)

Carl and Dorothy Bennett Cancer Center at Stamford Hospital

Stamford, Connecticut, United States

Valley Hospital - Paramus

Paramus, New Jersey, United States

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Outcomes

Primary Outcomes

Changes in lumbar spine bone mineral density (BMD) at 6 months

Secondary Outcomes

Changes in lumbar spine BMD at 12 and 24 months

Total hip and femoral neck BMD at 6, 12, and 24 months

Serum markers of bone turnover (osteocalcin, bone-specific alkaline phosphatase, and cross-linked C-telopeptide of type 1 collagen levels) measured every 6 weeks for 6 months, and at 9 and 12 months

Quality of life as measured by the Short Form-36 instrument at baseline, and at 6 and 12 months

Treatment costs

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.