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Hormone Therapy
Letrozole for Reducing Breast Cancer Risk in Postmenopausal Women
Phase 2
Waitlist Available
Led By Paul Goss, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue
Baseline breast examination demonstrating no clinical evidence of breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is looking at whether or not letrozole reduces breast density in postmenopausal women, as well as any potential side effects.
Who is the study for?
This trial is for postmenopausal women with a high breast density who have not had recent cancer treatments or hormone therapies. Women must be healthy, without serious diseases like uncontrolled diabetes or heart conditions, and should not have any signs of ongoing breast cancer. They need to be able to fill out questionnaires in English or French.Check my eligibility
What is being tested?
The study is testing the effects of letrozole, a medication, on breast density in postmenopausal women at risk for breast cancer over one year compared to a placebo (a pill with no active drug). It also aims to explore the relationship between estrogen levels and breast density and assess participants' quality of life during treatment.See study design
What are the potential side effects?
Letrozole may cause joint pain, hot flashes, weakness, fatigue, increased sweating and cholesterol levels. It can also lead to bone thinning which might increase fracture risk. Not everyone will experience these side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My last mammogram showed more than 25% breast density.
Select...
My recent breast exam showed no signs of cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.
Secondary outcome measures
To determine if the decrease in breast density grade is sustained one year after cessation of therapy
to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy
to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year
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Who is running the clinical trial?
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,295 Total Patients Enrolled
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132,852 Patients Enrolled for Breast Cancer
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,276 Total Patients Enrolled
47 Trials studying Breast Cancer
7,205 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,812 Total Patients Enrolled
141 Trials studying Breast Cancer
22,557 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My last mammogram showed more than 25% breast density.I have had cancer before, but it hasn't spread to other parts of my body.I had breast cancer before, it was surgically removed, and it didn't spread.My recent mammogram results were concerning for breast cancer.I do not have uncontrolled metabolic, heart diseases, or issues absorbing nutrients.I am a woman over 55 with no periods for 12 months or under 55 with specific hormone levels and no periods for 12 months, or I've had both ovaries removed.I have had a DEXA scan of my spine and hip within the last 6 months.I stopped taking Tamoxifen less than 6 months ago.I stopped hormone therapy or Evista less than 3 months ago.I can complete a quality of life survey in English or French.My recent breast exam showed no signs of cancer.I am currently undergoing chemotherapy or immunotherapy.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots left for volunteers in this research project?
"According to the information provided by clinicaltrials.gov, this study is not currently looking for patients as it was last edited on 1/18/2007. There are however, 2709 other trials that may be of interest and are actively recruiting participants."
Answered by AI
What are the risks of this procedure for patients?
"While there is some evidence that this intervention might be safe, it is still in the early stages of development. Therefore, it only received a score of 2."
Answered by AI
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