Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 40 and over NCI CALGB-79809 NCI-P01-0184, CALGB-79809, NCT00022087

Objectives

1. Compare the bone mineral density in the lumbar spine after 12 and 36 months of therapy with zoledronate, calcium, and cholecalciferol (vitamin D) in women with breast cancer receiving adjuvant chemotherapy.

Entry 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

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

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

Expected Enrollment

Approximately 400 patients (200 per treatment arm) will be accrued for this study within 24 months.

Outcomes

Bone mineral density in the lumbar spine after 12 and 36 months of therapy

Outline

This is a randomized, open-label, multicenter study. Patients are stratified according to intent to treat with tamoxifen (yes vs no) and node status (negative vs positive vs unknown [for patients receiving neoadjuvant therapy]). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Beginning on the first day of adjuvant chemotherapy (or within 3 months after the first day), patients receive zoledronate IV over at least 15 minutes once every 3 months during months 1-24 and oral calcium and oral cholecalciferol (vitamin D) daily during months 1-36.



• Arm II: Beginning on the first day of adjuvant chemotherapy (or within 3 months after the first day), patients receive oral calcium and oral vitamin D daily during months 1-36 and zoledronate IV over at least 15 minutes once every 3 months during months 13-36.

Shapiro CL, Halabi S, Gibson G, et al.: Effect of zoledronic acid (ZA) on bone mineral density (BMD) in premenopausal women who develop ovarian failure (OF) due to adjuvant chemotherapy (AdC): first results from CALGB trial 79809. [Abstract] J Clin Oncol 26 (Suppl 15): A-512, 2008.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Charles Shapiro, MD, Protocol chair		Ph: 614-293-6401 Email: charles.shapiro@osumc.edu

Registry Information
Official Title		Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients with Chemotherapy-Induced Ovarian Failure
Trial Start Date		2001-12-15
Registered in ClinicalTrials.gov		NCT00022087
Date Submitted to PDQ		2001-06-06
Information Last Verified		2006-03-11
NCI Grant/Contract Number		CA31946