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Hormone Therapy

Endocrine Therapy Before Surgery for Early-Stage Breast Cancer (POWER Trial)

Phase 2

Waitlist Available

Led By Shayna L Showalter, MD

Research Sponsored by Trish Millard, MD

Eligibility Criteria Checklist

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

Must have

Ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to BCS

ECOG performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days after surgery, chemotherapy completion, or rt completion, whichever is later

Awards & highlights

POWER Trial Summary

This trial is testing whether pre-operative endocrine therapy helps inform decisions on whether or not to omit radiation for elderly women with early stage breast cancer scheduled for breast conservation surgery.

Who is the study for?

This trial is for women aged 65 or older with early-stage, hormone receptor-positive breast cancer. Participants must have a tumor size ≤ 2 cm, be able to take oral medication, and commit to pre-surgery endocrine therapy for three months. They should not have used endocrine therapy before, be pregnant or breastfeeding, or require treatment for another progressing malignancy.Check my eligibility

What is being tested?

The study tests the tolerance of older women with breast cancer to pre-operative endocrine therapies like tamoxifen, letrozole, anastrozole, or exemestane over three months. Patient surveys will measure how well they tolerate the drugs before surgery.See study design

What are the potential side effects?

Possible side effects from these medications can include hot flashes, mood swings, fatigue, joint pain and bone thinning (osteoporosis). Each woman's experience may vary based on her health and reaction to the medication.

POWER Trial Eligibility Criteria

Inclusion Criteria

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

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I can take pills and will follow hormone therapy for 3 months before surgery.

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I can take care of myself and perform daily activities.

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I have chosen breast-conserving surgery.

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My tumor is 2 cm or smaller.

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I can take tamoxifen or an aromatase inhibitor.

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I have early-stage breast cancer that is ER positive and may or may not be PR positive, but is not HER2 positive.

POWER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days after surgery, chemotherapy completion, or rt completion, whichever is later

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days after surgery, chemotherapy completion, or rt completion, whichever is later

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after surgery, chemotherapy completion, or rt completion, whichever is later 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 participant preference for adjuvant radiation treatment

Change in surgeon preference for adjuvant radiation treatment

Secondary outcome measures

Beliefs about medicine as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS

Breast cancer beliefs as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS

Depression and anxiety as predictive measure for endocrine therapy adherence

+6 more

POWER Trial Design

1Treatment groups

Experimental Treatment

Group I: Pre-operative endocrine therapyExperimental Treatment2 Interventions

All participants enrolled to the study will receive 3 months of pre-operative endocrine therapy (e.g. tamoxifen or aromatase inhibitors (AIs) such as letrozole, anastrozole, or exemestane). The choice and dose of endocrine therapy will be at the discretion of the treating medical oncologist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient reported outcomes

2019

N/A

~100

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Trish Millard, MDLead Sponsor

Shayna Showalter, MDLead Sponsor

2 Previous Clinical Trials

386 Total Patients Enrolled

2 Trials studying Breast Cancer

386 Patients Enrolled for Breast Cancer

Shayna L Showalter, MDPrincipal InvestigatorUniversity of Virginia

Media Library

Tamoxifen/Letrozole/Anastrozole/Exemestane (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04272801 — Phase 2

Breast Cancer Research Study Groups: Pre-operative endocrine therapy

Breast Cancer Clinical Trial 2023: Tamoxifen/Letrozole/Anastrozole/Exemestane Highlights & Side Effects. Trial Name: NCT04272801 — Phase 2

Tamoxifen/Letrozole/Anastrozole/Exemestane (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04272801 — Phase 2

Frequently Asked Questions

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

In what scenarios is Patient Reported Outcomes typically utilized?

"Patient reported outcomes are primarily employed to battle malignant neoplasms, though they can also be used in the treatment of ovarian cancer, tamoxifen-induced illnesses, and high risk afflictions."

Answered by AI

How many individuals have been recruited to partake in this clinical trial?

"Affirmative. Clinicaltrials.gov lists this study as actively recruiting participants, starting from April 7th 2020 and last modified on March 16th 2022. The research currently needs 83 people to register across two centres."

Answered by AI

Are there any open spots left in this trial at the present time?

"Clinicaltrials.gov suggests that this research trial is actively looking for participants, having been initially posted on the 7th of April 2020 and modified most recently on the 16th of March 2022."

Answered by AI

What is the purpose of this research endeavor?

"The objective of this 6-month evaluation is to determine a difference in patient preferences for radiotherapy. Secondary objectives involve exploring the connection between adherence to endocrine therapy and breast cancer beliefs, symptom burden levels, and attitudes towards medication through the UVA Breast Cancer Belief Survey, BCPT Symptom Checklist, and Beliefs about Medicines Questionnaire respectively. Logistic regression techniques will be utilized to assess correlations between pre-treatment responses at 2 years post-operation with long-term adjuvant endocrine therapy adhesion rates."

Answered by AI

Does the FDA recognize Patient reported outcomes as valid evidence?

"Our team at Power believes the safety of patient reported outcomes can only be rated a 1 due to this being an early-phase trial with limited data available for efficacy and safety."

Answered by AI

What evidence exists of previous experiments that included patient-reported outcomes?

"Currently, 221 research projects are being conducted in regard to patient reported outcomes. 61 of these live clinical trials have reached stage 3 and are underway. Though many studies related to this topic occur in Shanghai, a total of 14,626 medical facilities across the globe are running experiments concerning Patient Reported Outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer

Shayna Showalter, MD 2020. "Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04272801.

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