Overview

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

Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Herbert Irving Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
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