Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast D… (NCT00114270) | Clinical Trial Compass
CompletedNot Applicable
Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density
United StatesStarted 2004-05
Plain-language summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may prevent breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss caused by letrozole. Giving letrozole together with zoledronate may prevent breast cancer and reduce bone loss.
PURPOSE: This randomized clinical trial is studying letrozole and zoledronate to see how well they work compared to letrozole and placebo or placebo alone in treating healthy postmenopausal women with high breast density.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Healthy participant
* Postmenopausal for \> 5 years
* Breast density ≥ 50% by digitized mammography
* No history of breast cancer, breast implant, or gynecological malignancy
* No osteoporosis or postmenopausal fractures
* T-scores ≥ -2.0 by dual-energy x-ray absorptiometry (DEXA) scan
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* See Disease Characteristics
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* AST or ALT ≤ 3 times normal
Renal
* Creatinine ≤ 1.5 mg/dL
Cardiovascular
* No cardiac disease
Other
* Nonsmoker
* Vitamin D ≥ 15 ng/mL
* No history of chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance or participation
* No alcohol consumption of \> 2 alcoholic drinks per day
* No malabsorption
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* At least 1 year since prior hormone replacement therapy
* No concurrent steroids, parathyroid hormone, or raloxifene
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No other concurrent medication known to affect calcium and bone metabolism (e.g., anticoagulants, antiseizure medications, bisphosphonates, or calcitonin)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.