What side effects are associated with this type of intervention?

Common treatments for breast cancer that block the effects of estrogen include tamoxifen and aromatase inhibitors. Tamoxifen, typically administered at 20 mg daily, can cause side effects such as hot flashes, increased risk of blood clots, and endometrial cancer. Lower doses may reduce toxicity but are less studied. Aromatase inhibitors, like anastrozole, are used in postmenopausal women and can lead to loss of bone density, fractures, and increased cardiovascular risk. Both treatments aim to reduce recurrence and improve survival but come with significant side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several anti-estrogen treatments for breast cancer, focusing on blocking the effects of estrogen. Tamoxifen, a selective estrogen receptor modulator (SERM), was one of the first to be approved and is widely used for both premenopausal and postmenopausal women. Aromatase inhibitors, including anastrozole, letrozole, and exemestane, are approved for postmenopausal women and work by inhibiting the enzyme aromatase, which converts androgens to estrogen. These treatments have shown efficacy in reducing recurrence and improving survival rates in hormone receptor-positive breast cancer.

What other types of research exist?

Promising novel alternatives to anti-estrogen treatment for breast cancer patients include: 1) CDK4/6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib) which inhibit cell cycle progression, 2) PI3K inhibitors (e.g., alpelisib) targeting the PI3K/AKT/mTOR pathway, and 3) PARP inhibitors (e.g., olaparib, talazoparib) for patients with BRCA mutations. These therapies offer different mechanisms of action and can be used in combination with or as alternatives to traditional anti-estrogen treatments.

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Hormone Therapy for Breast Cancer

Phase 2

Waitlist Available

Led By Lubna Chaudhary

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female; age ≥18 years.

Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.

Must not have

American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer.

Men with breast cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at four weeks.

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial uses a specific type of medication before surgery for patients with certain types of breast cancer. It aims to see how well the tumors respond by blocking estrogen, which helps some cancers grow. This approach helps doctors understand the treatment's effects better. A certain medication has shown to be effective in the treatment and prevention of breast cancer.

Who is the study for?

This trial is for women over 18 with early-stage, node-negative breast cancer that's hormone receptor-positive and HER2-negative. They should be in good health with no other recent cancers (except certain types) or strong CYP2D6 inhibitors used. Participants must not be pregnant, have completed any prior breast cancer treatments two years ago, and agree to use contraception.

What is being tested?

The study tests the effects of starting standard anti-estrogen treatments like Anastrozole, Letrozole, Exemestane, or Tamoxifen before surgery. It's a preoperative intervention lasting four weeks to see how these drugs work when given earlier in treatment.

What are the potential side effects?

Potential side effects from the anti-estrogen medications may include hot flashes, joint pain, fatigue, mood swings, decreased sex drive and bone density loss. Each drug has its own profile of possible side effects which can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 or older.

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I have been diagnosed with early-stage breast cancer.

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My tumor is positive for estrogen or progesterone.

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I am able to get out of my bed or chair and move around.

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My cancer is HER2 negative according to tests.

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My lymph nodes do not have cancer, confirmed by exams and imaging.

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I am not taking any strong medications that affect liver enzyme CYP2D6.

Exclusion Criteria

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

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My breast cancer is advanced, affecting nearby lymph nodes or other parts of my body.

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I am a man diagnosed with breast cancer.

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My breast cancer is noninvasive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at four weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at four weeks.

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

Treatment Details

Study Objectives

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

Primary study objectives

Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.

Secondary study objectives

Number of Subjects Who Achieve Complete Radiographic Response.

Number of Subjects Who Achieve a Partial Radiographic Response.

Awards & Highlights

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant endocrine therapy treatment (physician's choice)Experimental Treatment4 Interventions

Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exemestane

FDA approved

Anastrozole

FDA approved

Letrozole

FDA approved

Tamoxifen

FDA approved

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

Anti-estrogen treatments, such as tamoxifen and aromatase inhibitors, are commonly used in hormone receptor-positive breast cancer. Tamoxifen works by binding to estrogen receptors on breast cancer cells, blocking estrogen from stimulating cancer growth. Aromatase inhibitors, like anastrozole, reduce the production of estrogen by inhibiting the enzyme aromatase, which converts androgens to estrogen. These treatments are crucial for breast cancer patients because they target the hormonal pathways that often drive the growth of hormone receptor-positive breast cancers, thereby slowing disease progression and reducing the risk of recurrence.