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Selective Estrogen Receptor Modulator
Tamoxifen vs. TamGel for Breast Cancer Risk Reduction
Phase 2
Recruiting
Led By Amy Degnim, M.D.
Research Sponsored by Amy C. Degnim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female (sex that was assigned at birth)
Ipsilateral intact breast with histology confirmation of atypical ductal or lobular hyperplasia, or LCIS, within the last 5 years, whether surgically excised or not
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial will study breast tissue changes after taking Tamoxifen, a drug used to treat breast cancer.
Who is the study for?
This trial is for women with a specific breast condition called atypical hyperplasia or LCIS, who can return for follow-up and handle questionnaires. They must have an ECOG status ≤1 (which means they're fully active or restricted in physically strenuous activity but ambulatory), use effective birth control, avoid sun exposure on breasts, and have good organ function. Pregnant women, recent thromboembolism patients, those treated for breast cancer within 2 years, or users of certain drugs are excluded.Check my eligibility
What is being tested?
The study compares the effects of oral Tamoxifen versus a topical gel form (TamGel) against a placebo in altering breast tissue over a short period. Women will be randomly assigned to one of these treatments to see how each affects their condition.See study design
What are the potential side effects?
Possible side effects include hot flashes, vaginal dryness or discharge, mood swings, blood clots (rarely), vision changes like cataracts (long-term use), and an increased risk of uterine cancer (for those still with a uterus).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was assigned female at birth.
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My breast has abnormal cells confirmed in the last 5 years, not necessarily removed.
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I am fully active or have some restrictions but can still care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The purpose of this research is to evaluate short-term changes in background breast tissue induced by oral tamoxifen or 4-OHT gel in women with atypical hyperplasia or lobular carcinoma in situ (LCIS).
Trial Design
3Treatment groups
Experimental Treatment
Group I: Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/dayExperimental Treatment1 Intervention
Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day
+oral placebo
Group II: Oral Tamoxifen 10 mg/dayExperimental Treatment1 Intervention
Oral Tamoxifen 10 mg/day
Group III: ControlExperimental Treatment1 Intervention
Oral and gel placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Tamoxifen
FDA approved
Find a Location
Who is running the clinical trial?
Amy C. DegnimLead Sponsor
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,264 Total Patients Enrolled
Amy Degnim, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during and for 2 months after the study, and I am not pregnant.I quit smoking more than 6 weeks ago.I haven't used any hormonal treatments, including birth control pills, in the last month.You had a blood clot in the past 5 years, you are currently pregnant or breastfeeding, or you had certain treatments for breast cancer in the past 2 years.I am not taking medications like bupropion or fluoxetine that affect tamoxifen.I have a lump that doctors are concerned about.I am willing to keep my breast skin away from sunlight and tanning beds during the study.If you can have children, you need to have a negative urine pregnancy test. If you cannot have children, your FSH levels need to show that you are in menopause.I was assigned female at birth.My breast has abnormal cells confirmed in the last 5 years, not necessarily removed.My organs and bone marrow are functioning well according to recent tests.I have had endometrial cancer before.You have had allergic reactions to tamoxifen in the past.I have used medications like tamoxifen or letrozole in the past 5 years.I have had a suspicious breast mass or was diagnosed with breast cancer in the last 5 years.I haven't had chemotherapy in the last 2 years.I have skin issues on my breast like eczema or open sores.I use vaginal estrogen or a hormone IUD, and I've had radiation on one breast before.I am on blood thinners and cannot stop them for a biopsy.I am fully active or have some restrictions but can still care for myself.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Tamoxifen 10 mg/day
- Group 2: Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day
- Group 3: Control
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
Could you tell me if Tamoxifen has been used in other medical studies?
"Presently, 73 clinical trials are underway that focus on Tamoxifen with 24 of those in Phase 3. Some of the research for Tamoxifen is being conducted in Moline, Illinois; however, there are 7487 total locations running trials for this medication."
Answered by AI
What are doctors using Tamoxifen to treat these days?
"Tamoxifen is a versatile medication that can be used to treat conditions like ovarian cancer, high risk patients, and malignant neoplasms."
Answered by AI
Are adolescents eligible for prescription in this research project?
"Enrolment for this study is open to adults aged 18 and above, with the cut-off age being 80."
Answered by AI
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