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Aromatase Inhibitor

Hormone Therapy for Early Stage Breast Cancer

Q: Why is Tamoxifen prescribed to patients?

<p>Tamoxifen is most commonly used to treat <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, but it can also help manage other conditions like ovarian cysts and high-risk pregnancies.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.

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

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

~840

Tamoxifen

2005

Completed Phase 4

~30070

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any severe side effects associated with Tamoxifen?

"Although there is some data supporting Tamoxifen's safety, it did not receive a high score because Phase 2 trials have not demonstrated efficacy."

Answered by AI

Does the age limit for this program stop at 80 years old?

"The age range for patients that this trial is looking to enroll are those who have turned 18 years old, up until those who are 99."

Answered by AI

Are patients being actively sought for this trial?

"Yes, this study is still recruiting patients. The original posting was on February 18th, 2022 and the last update was on October 18th of the same year."

Answered by AI

How prevalent is this research among those affected?

"That is correct, the information available on clinicaltrials.gov points to this study actively recruiting patients. The trial was initially posted on February 18th, 2022 and updated as recently as October 18th, 2022. Presently, the study is looking for 70 participants across 1 site."

Answered by AI

Why is Tamoxifen prescribed to patients?

"Tamoxifen is most commonly used to treat cancer, but it can also help manage other conditions like ovarian cysts and high-risk pregnancies."

Answered by AI

Do we have any prior research to draw upon for this Tamoxifen study?

"At this time, there are 234 active studies researching the effects of Tamoxifen. Out of these, 66 trials are in Phase 3. Additionally, while some of the clinical trials for Tamoxifen are based in Shanghai, there are 16106 locations running trials for Tamoxifen worldwide."

Answered by AI

Who would be an eligible candidate for this research project?

"This study is looking for 70 individuals that have breast cancer and are between 18 to 99 years old. To be eligible, patients must meet the following requirements: being postmenopausal and having a medical oncologist's approval for anti-endocrine treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Veronica Morgan Jones 2022. "Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05150652.

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