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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ after neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)

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

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

Primary study objectives

Change in margin status

Secondary study objectives

Change in satisfaction with cosmetic outcome

Pattern of response

Residual cancer burden

Other study objectives

Change in largest caliper measurement

Awards & Highlights

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 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