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

Phase 2Active Not RecruitingNCT04272801

Shayna Showalter, MD84 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Female

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

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria (Summary): * 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 Exclusion Criteria (Summary): * 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

Locations (2)

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment

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

Time frame: 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

Time frame: up to 6 months

Secondary Outcomes

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

Health related quality of life will be assessed using the EORTC QLQ-C30 and QLQ-BR23.

Time frame: 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

General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist.

Time frame: 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

Illness perception will be assessed using the Brief Illness Perception Questionnaire.

Time frame: 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

Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire.

Data from ClinicalTrials.gov

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