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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

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 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.

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

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.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
620 Previous Clinical Trials
1,172,537 Total Patients Enrolled
14 Trials studying Breast Cancer
409,436 Patients Enrolled for Breast Cancer
Lubna ChaudharyPrincipal InvestigatorMedical College of Wisconsin

Media Library

Breast Cancer Research Study Groups: Neoadjuvant endocrine therapy treatment (physician's choice)
Breast Cancer Clinical Trial 2023: Exemestane Highlights & Side Effects. Trial Name: NCT03219476 — Phase 2
~4 spots leftby Sep 2025
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