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

NCT04272801 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: 220405R21CA277311-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Breast Cancer Female

Keywords

breast cancer; endocrine therapy; radiation; letrozole; anastrozole; exemestane; tamoxifen; survey; questionnaire; geriatric

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment

  Change in participant response to question regarding preference for adjuvant radiation treatment

  up to 6 months

• Change in Surgeon Preference for Adjuvant Radiation Treatment

  Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment

  up to 6 months

Secondary Outcomes (9)

• Health Related Quality of Life Surveys as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS

  Through 24 months after start of adjuvant treatment period

• General Symptom Burden as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS

  Through 24 months after start of adjuvant treatment period

• Illness Perception as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS

  Through 24 months after start of adjuvant treatment period

• 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

  Through 24 months after start of adjuvant treatment period

• Perceived Sensitivity to Medicine as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS

  Through 24 months after start of adjuvant treatment period

Study Arms (1)

Pre-operative endocrine therapy

EXPERIMENTAL

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.

Drug: tamoxifen, letrozole, anastrozole, or exemestane; Behavioral: Patient reported outcomes

Interventions

tamoxifen, letrozole, anastrozole, or exemestane DRUG

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

Also known as: Endocrine therapy

Pre-operative endocrine therapy

Patient reported outcomes BEHAVIORAL

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

Also known as: surveys, questionnaires

Pre-operative endocrine therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ECOG performance status 0-2
• Diagnosed with anatomic stage I, ER positive, PR positive or negative, and HER2 non amplified invasive breast cancer and clinically negative nodes; any invasive breast cancer histologic subtype may be enrolled
• Tumor size ≤ 2 cm
• Patient has elected BCS as surgical choice
• Eligible to receive tamoxifen or an aromatase inhibitor
• Ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to BCS

You may not qualify if:

• Prior or current use of endocrine therapy for breast cancer
• History of ipsilateral breast radiation
• Pregnancy or lactation
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Current or planned use of a strong CYP2D6 inhibitor (e.g. Fluoxetine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway

Sponsors & Collaborators

• Shayna Showalter, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Letrozole; Anastrozole; exemestane; Patient Reported Outcome Measures; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Health Care Surveys; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Shayna Showalter
• Organization: University of Virginia

snl2t@uvahealth.org

434-956-8032

Study Officials

• Shayna L Showalter, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Pilot, 1 arm

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 17, 2020
• Study Start: April 7, 2020
• Primary Completion: June 5, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-09

Locations

US (2)