Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss.

PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Calcium, Dietary; Cholecalciferol; Diphosphonates; Ergocalciferols; Vitamin D; Vitamins; Zoledronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast by fine needle aspirate, biopsy (tru-cut, core, stereotactic), lumpectomy, or modified radical mastectomy

• Stage I-III (any T, any N, M0)

• Stage IV due solely to supraclavicular node involvement allowed

• Plan to use adjuvant chemotherapy* with or without adjuvant endocrine therapy*

• Subsequent adjuvant hormonal therapy with an aromatase inhibitor allowed in women rendered postmenopausal by adjuvant chemotherapy NOTE: *Must be specified prior to study entry

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 40 and over

Sex:

• Female

Menopausal status:

• See Disease Characteristics

• Premenopausal, defined as actively menstruating or last menstrual period occurred within 6 months prior to study entry

• Prior hysterectomy without bilateral oophorectomy and estradiol and follicle-stimulating hormone within premenopausal range prior to the initiation of chemotherapy allowed

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No more than 3 months since prior adjuvant chemotherapy

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

• See Menopausal status

Other:

• No other concurrent bisphosphonates

• No concurrent digoxin

• No concurrent tetracycline

• Concurrent neoadjuvant therapy allowed

• Concurrent enrollment on therapeutic adjuvant clinical trials allowed provided the therapeutic trial does not preclude participation in this trial