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

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00022087

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Osteoporosis	Dietary Supplement: calcium carbonate Dietary Supplement: calcium citrate Dietary Supplement: cholecalciferol Drug: calcium gluconate Drug: zoledronic acid Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Calcium Cancer Dietary Supplements Diets Osteoporosis

Drug Information available for: Cholecalciferol Zoledronic acid Calcium gluconate Calcium carbonate Calcium citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Study Start Date:

December 2001

Detailed Description:

OBJECTIVES:

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.

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.

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

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022087

Show 107 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Shapiro, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000068781, CALGB-79809, NCI-P01-0184
Study First Received:	August 10, 2001
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00022087 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

osteoporosis
stage I breast cancer
stage II breast cancer
stage IV breast cancer

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Cholecalciferol
Zoledronic acid
Immunologic Factors
Skin Diseases
Citric Acid
Adjuvants, Immunologic
Breast Neoplasms
Osteoporosis
Trace Elements
Bone Density Conservation Agents
Ovarian Failure, Premature
Bone Diseases, Metabolic

Calcium Carbonate
Bone Diseases
Calcium, Dietary
Vitamin D
Musculoskeletal Diseases
Vitamin D3
Vitamins
Citrate
Antacids
Calciferol
Micronutrients
Breast Diseases

Additional relevant MeSH terms:

Cholecalciferol
Zoledronic acid
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Skin Diseases
Growth Substances
Physiological Effects of Drugs
Adjuvants, Immunologic
Breast Neoplasms
Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic

Calcium Carbonate
Bone Diseases
Pharmacologic Actions
Calcium, Dietary
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Vitamins
Antacids
Micronutrients
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009