CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 84 enrolled
Drug / intervention
tamoxifen, letrozole, anastrozole, or exemestane +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04272801
NCT04272801Phase 2Active

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

Shayna Showalter, MD·interventional·Posted Feb 17, 2020·Updated Oct 22, 2025

In Brief

A Phase 2 clinical trial evaluating tamoxifen, letrozole, anastrozole, or exemestane and Patient reported outcomes for Breast Cancer Female. Active but no longer recruiting, targeting 84 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2ActiveOverdue
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartApr 7, 2020
Primary CompletionJun 5, 2024
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.4 years ago

Interventions

tamoxifen, letrozole, anastrozole, or exemestanedrug

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

Patient reported outcomesbehavioral

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