Home
Search
Study Topics
Glossary
|
Study 7 of 950 for search of: | United States, Vermont |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00022087 |
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 Cancer-Related Problem/Condition |
Drug: calcium carbonate Drug: calcium citrate Drug: calcium gluconate Drug: cholecalciferol 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 |
Study Start Date: | December 2001 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: Approximately 400 patients (200 per treatment arm) will be accrued for this study within 24 months.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast by fine needle aspirate, biopsy (tru-cut, core, stereotactic), lumpectomy, or modified radical mastectomy
Plan to use adjuvant chemotherapy* with or without adjuvant endocrine therapy*
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Premenopausal, defined as actively menstruating or last menstrual period occurred within 6 months prior to study entry
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Charles L. Shapiro, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000068781, CALGB-79809, NCI-P01-0184 |
Study First Received: | August 10, 2001 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00022087 |
Health Authority: | United States: Federal Government |
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 |
Calcium, Dietary Cholecalciferol Vitamin D Zoledronic acid Skin Diseases Citric Acid |
Ergocalciferols Osteoporosis Breast Neoplasms Ovarian Failure, Premature Calcium Carbonate Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Antacids Bone Density Conservation Agents Micronutrients Pharmacologic Actions |