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Aromatase Inhibitor

Hormone Therapy for Early Stage Breast Cancer

Phase 2
Recruiting
Led By Veronica M Jones, MD
Research Sponsored by Veronica Morgan Jones
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed invasive breast cancer, clinically stage I-II
Postmenopausal women
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
Uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)
Awards & highlights

Summary

This trial will test whether giving hormone therapy to early-stage breast cancer patients before surgery results in higher rates of margin-negative lumpectomies.

Who is the study for?
This trial is for postmenopausal women with early stage I-II, estrogen-rich breast cancer that's not spread to lymph nodes. They must be able to take anti-endocrine therapy and sign a consent form. Women with progesterone-negative tumors, high-grade tumors, other cancers, or allergies to the study drugs can't join.Check my eligibility
What is being tested?
The study tests if using neoadjuvant endocrine therapy (Anastrozole, Letrozole, Exemestane or Tamoxifen) before surgery improves outcomes in breast cancer by increasing the chances of completely removing the tumor without leaving any cancerous tissue at the edges.See study design
What are the potential side effects?
Possible side effects include hot flashes, joint pain, muscle aches, fatigue, increased sweating and mood swings. Rarely there might be bone thinning or changes in cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is confirmed and is in the early stages (I or II).
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I am a woman who has gone through menopause.
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My cancer has not spread to my lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to certain cancer medications like Anastrozole or Tamoxifen.
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I do not have any unmanaged ongoing illnesses.
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I have another cancer type at the same time as my breast cancer.
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My cancer is not driven by progesterone.
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My tumor is high grade.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in margin status
Secondary outcome measures
Change in satisfaction with cosmetic outcome
Pattern of response
Residual cancer burden
Other outcome measures
Change in largest caliper measurement

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Endocrine TherapyExperimental Treatment4 Interventions
Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole 1mg
2001
Completed Phase 2
~70
Letrozole 2.5mg
2019
Completed Phase 4
~1070
Tamoxifen
2005
Completed Phase 4
~30070

Find a Location

Who is running the clinical trial?

Veronica Morgan JonesLead Sponsor
Erin BurkeLead Sponsor
Emily MarcinkowskiLead Sponsor

Media Library

Anastrozole 1mg (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05150652 — Phase 2
Breast Cancer Research Study Groups: Neoadjuvant Endocrine Therapy
Breast Cancer Clinical Trial 2023: Anastrozole 1mg Highlights & Side Effects. Trial Name: NCT05150652 — Phase 2
Anastrozole 1mg (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05150652 — Phase 2
~33 spots leftby Oct 2026
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