Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer (NCT01077453) | Clinical Trial Compass
CompletedPhase 1
Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer
United States112 participantsStarted 2010-03
Plain-language summary
This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk for breast cancer.
Who can participate
Age range
35 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.
Inclusion Criteria:
* Healthy postmenopausal women at "high risk" for breast cancer will be eligible for the study; definition of menopause will be:
* Amenorrhea for at least 12 months, or
* History of hysterectomy and bilateral salpingo-oophorectomy, or
* At least 55 years of age with prior hysterectomy with or without oophorectomy, or
* Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
* "High risk" for breast cancer will be defined as:
* Prior histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only, or
* At least 1.66% probability of invasive breast cancer within 5 years using the Breast Cancer Risk Assessment Tool
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Karnofsky 80% or above
* Leukocytes \>= 3,000/uL
* Absolute neutrophil count \>= 1,500/uL
* Platelets \>= 100,000/uL
* Total bilirubin =\< 2.0 mg/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.0 X institutional ULN
* Creatinine =\< 1 X institutional ULN
* Recent mammogram negative for breast cancer, Breast Imaging-Reporting and Data System (BIRADS) score \< 3 (within the last 12 months)
* Ability to understand and the willingness to sign a written informed consent documen…
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.
What they're measuring
1
Percentage of serum estradiol suppression in postmenopausal women at high risk for breast cancer