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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00107263 |
Purpose
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss in patients who are receiving letrozole. It is not yet known which schedule of zoledronate is more effective in preventing bone loss in patients with breast cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of zoledronate to compare how well they work in preventing bone loss in postmenopausal women who are receiving letrozole for stage I, stage II, or stage IIIA breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Osteoporosis |
Drug: letrozole Drug: zoledronic acid Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Controlled, Open-Label Trial of Empiric Prophylactic vs. Delayed Use of Zoledronic Acid for Prevention of Bone Loss in Postmenopausal Women With Breast Cancer Initiating Therapy With Letrozole After Tamoxifen |
| Study Start Date: | January 2005 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to duration of prior tamoxifen therapy (≤ 2 years vs > 2 years); time since tamoxifen therapy was discontinued (< 1 vs ≥ 1 year); prior adjuvant chemotherapy (yes vs no); and baseline total lumbar spine or femoral neck bone mineral density (BMD) T-score (> -1 standard deviation [SD] vs between -1 to -2 SD). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 28 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined by 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No contraindication to spinal dual energy x-ray absorptiometry (DEXA) due to any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 12 months since prior endocrine therapy (including estrogen) except for the following:
More than 12 months since prior systemic corticosteroids except short-term corticosteroids to prevent or treat chemotherapy-induced nausea and vomiting or acute respiratory illness
Radiotherapy
Surgery
Other
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00107263 History of Changes |
| Other Study ID Numbers: | CDR0000413877, NCCTG-N03CC |
| Study First Received: | April 5, 2005 |
| Last Updated: | June 16, 2010 |
| Health Authority: | United States: Federal Government |
|
osteoporosis stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Breast Neoplasms Osteoporosis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Letrozole |
Zoledronic acid Diphosphonates Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Bone Density Conservation Agents Physiological Effects of Drugs |