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Hormone Therapy

Endocrine Therapy for Low-Risk Breast Cancer

Phase 2

Recruiting

Led By Rebecca L Aft, M.D, Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤ 3

Disease must be ER+ and HER2-

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether endocrine therapy alone is an effective treatment for a subpopulation of elderly women with good prognosis estrogen receptor positive breast cancer and low Ki67 scores.

Who is the study for?

This trial is for women aged 70 or older with a specific type of breast cancer that's sensitive to hormones and hasn't spread widely (ER+ operable invasive breast cancer, cT1 or T2, N0-1, M0). Participants should have low levels of a protein called Ki67, be able to perform daily activities with some limitations (ECOG ≤ 3), and not have had previous surgery for this cancer. Women with HIV on antiretroviral therapy, other recent cancers, or severe illnesses are excluded.Check my eligibility

What is being tested?

The study tests if endocrine therapy alone can control breast cancer in elderly women without the need for surgery. It involves treatments like Fulvestrant, Tamoxifen, Anastrozole, Exemestane and Goserelin. The effectiveness will be measured by changes in tumor size using ultrasound or mammogram and quality of life assessments.See study design

What are the potential side effects?

Endocrine therapies may cause hot flashes, joint pain, fatigue, mood swings and slight nausea. Rarely they might affect bone density leading to osteoporosis over time. Each medication has its own set of potential side effects which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am capable of only limited self-care, confined to my bed or chair more than 50% of waking hours.

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My cancer is estrogen receptor positive and HER2 negative.

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I am 70 years old or older.

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I have been newly diagnosed with early-stage breast cancer that can be surgically removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate

Secondary outcome measures

Breast cancer-specific survival

Rate of overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endocrine therapy aloneExperimental Treatment7 Interventions

Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Tamoxifen

2005

Completed Phase 4

~30070

Anastrozole

2019

Completed Phase 4

~10300

Exemestane

2003

Completed Phase 4

~7880

Goserelin

2008

Completed Phase 3

~4110

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genomic Health®, Inc.Industry Sponsor

14 Previous Clinical Trials

5,270 Total Patients Enrolled

5 Trials studying Breast Cancer

512 Patients Enrolled for Breast Cancer

Washington University School of MedicineLead Sponsor

1,936 Previous Clinical Trials

2,299,802 Total Patients Enrolled

46 Trials studying Breast Cancer

5,118 Patients Enrolled for Breast Cancer

Rebecca L Aft, M.D, Ph.D.Principal InvestigatorWashington University School of Medicine

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02476786 — Phase 2

Breast Cancer Research Study Groups: Endocrine therapy alone

Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT02476786 — Phase 2

Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02476786 — Phase 2

Frequently Asked Questions

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

What hazards have been associated with the medication Tamoxifen?

"With limited data in regards to efficacy, Tamoxifen was estimated at a safety rating of 2."

Answered by AI

Is this research initiative recruiting participants at the moment?

"According to clinicaltrials.gov, the search for participants is still underway for this trial which was first published in January of 2017 and last updated on July 27th 2022."

Answered by AI

What medical conditions is Tamoxifen typically used to treat?

"As a common treatment for disease progression, tamoxifen is utilized to address malignant neoplasms, stage T2b carcinoma of the prostate, and ovarian cancer."

Answered by AI

How many participants have been recruited for this research endeavor?

"Indeed, the information publicly available on clinicaltrials.gov suggests that this medical trial is currently enrolling patients. This research was initially published on January 17th, 2017 and has been routinely modified since then with its most recent edit being made July 27th 2022. The study seeks to recruit 50 people from one site in particular."

Answered by AI

Have any other investigations focused on the use of Tamoxifen?

"Currently, Tamoxifen is being investigated in 284 distinct clinical trials. Out of these studies, 88 have entered Phase 3 and are conducted across 19224 locations with Shanghai leading the way for research sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

2017. "Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02476786.

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