What side effects are associated with this type of intervention?

Tamoxifen, commonly used for treating Breast Lobular Carcinoma in Situ (LCIS), has several known side effects. These include an increased risk of endometrial cancer, thromboembolic events (such as deep vein thrombosis and pulmonary embolism), hot flashes, and ocular toxicity (including retinopathy). Other side effects may include menopausal symptoms, such as vaginal dryness and mood swings. Aromatase inhibitors, another class of drugs used in postmenopausal women, can cause bone density loss, fractures, and cardiovascular risks.

What prior FDA approvals exist?

Tamoxifen is a well-known FDA-approved treatment for Lobular Carcinoma in Situ (LCIS) due to its ability to block estrogen's effects on breast tissue. Other similar treatments include Raloxifene, another SERM, which has also been approved for reducing the risk of invasive breast cancer in postmenopausal women with LCIS. Additionally, aromatase inhibitors like Anastrozole and Letrozole, which reduce estrogen production, have been used in similar contexts for breast cancer prevention and treatment.

What other types of research exist?

Promising alternatives to Tamoxifen for Breast Lobular Carcinoma in Situ patients include: <ol> <li>Aromatase Inhibitors (AIs): These drugs, such as anastrozole, letrozole, and exemestane, reduce estrogen levels by inhibiting the enzyme aromatase, which converts androgens to estrogens. They are effective in postmenopausal women.</li> <li>Selective Estrogen Receptor Degraders (SERDs): Fulvestrant is a SERD that not only blocks but also degrades the estrogen receptor, offering a different mechanism of action compared to Tamoxifen.</li> <li>Cyclin-Dependent Kinase 4/6 (CDK4/6) Inhibitors: When combined with hormone therapy, drugs like palbociclib, ribociclib, and abemaciclib have shown improved outcomes in hormone receptor-positive breast cancer.</li> <li>Neurokinin 3 Receptor Antagonists: These are emerging as potential treatments for hot flashes and may offer additional benefits in hormone modulation. Patients should discuss these options with their healthcare provider to determine the best course of action based on their specific medical condition and treatment goals.</li> </ol>

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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

Must not have

Current users of potent inhibitors of tamoxifen metabolism. The potent inhibitors of tamoxifen metabolism are: bupropion, cinacalcet, fluoxetine, paroxetine, quinidine

Identification of a clinically suspicious mass on examination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

Summary

This trial is testing two forms of tamoxifen—a low-dose pill and a skin-applied gel. It targets women with conditions that put them at higher risk for breast cancer. The medication works by blocking estrogen, which can help stop cancer cells from growing. Tamoxifen is a well-established treatment for breast cancer, known for its ability to block estrogen receptors and reduce breast cancer incidence.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications like bupropion or fluoxetine that affect tamoxifen.

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I have a lump that doctors are concerned about.

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I have had endometrial cancer before.

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I have used medications like tamoxifen or letrozole in the past 5 years.

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I have had a suspicious breast mass or was diagnosed with breast cancer in the last 5 years.

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I haven't had chemotherapy in the last 2 years.

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I have skin issues on my breast like eczema or open sores.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 Treatment2 Interventions

Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day +oral placebo

Group II: Oral Tamoxifen 10 mg/dayExperimental Treatment2 Interventions

Oral Tamoxifen 10 mg/day

Group III: ControlExperimental Treatment2 Interventions

Oral and gel placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamoxifen

FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Breast Lobular Carcinoma in Situ (LCIS) include Selective Estrogen Receptor Modulators (SERMs) like Tamoxifen, which block estrogen's effects on breast tissue. These treatments are crucial for LCIS patients because they target the hormonal pathways that often drive the growth of breast cancer cells. By blocking estrogen receptors, SERMs prevent estrogen from binding to these receptors, thereby inhibiting the proliferation of potentially cancerous cells. This is particularly important for LCIS patients, as the condition is often hormone receptor-positive, meaning that the cancer cells grow in response to estrogen. Understanding these mechanisms helps in tailoring effective treatment plans that can reduce the risk of progression to invasive breast cancer.

Duct carcinoma in situ: A personal perspective.Preoperative chemotherapy and endocrine therapy in patients with breast cancer.