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ACTIVE NOT RECRUITING
NCT04272801
PHASE2

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

Sponsor: Shayna Showalter, MD

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2020-04-07

Completion Date

2026-06-01

Last Updated

2025-10-22

Healthy Volunteers

No

Interventions

DRUG

tamoxifen, letrozole, anastrozole, or exemestane

choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist

BEHAVIORAL

Patient reported outcomes

Questionnaire inquiries include the following: * how cancer affects daily living * beliefs about medicines and sensitivity to medicine * symptoms * adherence to endocrine therapy * general health and well being * depression and anxiety * preference regarding radiation therapy

Locations (2)

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States