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

Breast Cancer Female Clinical Trial

Official title:
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions In Older Women With Early-Stage Breast Cancer

Clinical Trial Summary

This is a prospective multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated with 3 months of pre-operative endocrine therapy (pre-ET) with assessment of tolerance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).

Clinical Trial Description

This single arm pilot study evaluates the use of pre-operative endocrine therapy in women with early stage ER+ breast cancer who are 65 years or older and are scheduled to have breast conservation surgery (BCS). The purpose of this study is to see if tolerance of pre-operative endocrine therapy helps inform decisions on whether or not to omit radiation. Participants will be treated with the novel approach of 3 months of pre-operative endocrine therapy, so that the participants and providers will have some indication of tolerance prior to making a decision about radiation omission. Tolerance of the endocrine therapy will be assessed by patient reported outcome (PRO) measures during neoadjuvant and adjuvant endocrine therapy treatment periods. Breast cancer participants and their surgical oncologists will be asked their preference regarding radiation therapy before starting endocrine therapy and again pre-operatively. They will make a determination regarding radiation therapy as per standard care. The hypothesis is that knowledge of tolerance of endocrine therapy will influence the decision by the patient and the surgical oncologist whether or not to elect radiation omission. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04272801
Study type Interventional
Source University of Virginia
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 7, 2020
Completion date June 7, 2025
View Details
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