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Anti-estrogen

Standard-of-care Endocrine therapy for Breast Cancer

Phase 2

Waitlist Available

Led By Lubna N Chaudhary, MD

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of surgery

Awards & highlights

Study Summary

"This trial is testing a new approach where patients will start taking anti-estrogen medication before surgery for 4-12 weeks to see its effects."

Who is the study for?

This trial is for individuals with hormone receptor-positive, HER2-negative breast cancer. Participants will receive standard anti-estrogen treatment before surgery for about 4 to 12 weeks. Specific eligibility details are not provided.Check my eligibility

What is being tested?

The study tests how effective aromatase inhibitors or tamoxifen are when given as a short-term neoadjuvant (pre-surgery) endocrine treatment in patients with certain types of breast cancer.See study design

What are the potential side effects?

Potential side effects may include hot flashes, joint pain, fatigue, mood swings, and changes in menstrual flow for premenopausal women from aromatase inhibitors or tamoxifen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of 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 from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors.

Change from baseline in the number of subjects with increased HER-2 receptor tyrosine kinases protein expression in tumors.

Change from baseline in the number of subjects with increased HER-3 receptor tyrosine kinases protein expression in tumors.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard-of-care Endocrine therapyExperimental Treatment1 Intervention

Once enrolled, patients would be treated with the current standard-of-care endocrine therapy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,613 Total Patients Enrolled

14 Trials studying Breast Cancer

409,373 Patients Enrolled for Breast Cancer

Lubna N Chaudhary, MDPrincipal InvestigatorMedical College of Wisconsin

Frequently Asked Questions

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

Are there any available slots for patients to participate in this research study?

"The ongoing clinical trial, as documented on clinicaltrials.gov, is not actively seeking volunteers at present. The trial was initially listed on August 1st, 2024 and last revised on April 8th, 2024. Although this specific study is not recruiting participants currently, there are a total of 2714 other trials that are actively seeking candidates for participation."

Answered by AI

Has the endocrine therapy which is currently accepted as a standard treatment been officially authorized by the FDA?

"Based on our assessment, the safety rating for the standard-of-care endocrine therapy in this Phase 2 trial is designated as a 2. This indicates that while there is evidence supporting its safety profile, efficacy data remains inconclusive at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer

Lubna Chaudhary 2024. "Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06361940.