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

Primary Purpose

Breast Cancer Female

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

tamoxifen, letrozole, anastrozole, or exemestane

Patient reported outcomes

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring breast cancer, endocrine therapy, radiation, letrozole, anastrozole, exemestane, tamoxifen, survey, questionnaire, geriatric

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of VirginiaRecruiting
Virginia Commonwealth University Massey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre-operative endocrine therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in participant preference for adjuvant radiation treatment

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

Change in surgeon preference for adjuvant radiation treatment

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

Secondary Outcome Measures

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.

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.

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.

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.

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

Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale.

Breast cancer beliefs as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS

Breast cancer beliefs will be assessed using the UVA Breast Cancer Belief Survey, a novel series of questions regarding patient beliefs about breast cancer and breast cancer medications.

Treatment decision as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS.

Treatment decision will be assessed using the Treatment Decision Survey, a novel series of questions regarding why subjects decide to have or not to have radiation therapy, and why or why not to restart endocrine therapy.

Perceptions related to medical choices as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS.

Subjects' perceptions related to their medical choices will be assessed using the Decisional Conflict Scale and the Decision Regret Scale.

Depression and anxiety as predictive measure for endocrine therapy adherence

Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised.

Full Information

NCT ID

NCT04272801

First Posted

February 4, 2020

Last Updated

October 19, 2023

Sponsor

Shayna Showalter, MD

1. Study Identification

Unique Protocol Identification Number

NCT04272801

Brief Title

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

Acronym

POWER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 7, 2020 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

June 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shayna Showalter, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Pilot, 1 arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pre-operative endocrine therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

tamoxifen, letrozole, anastrozole, or exemestane

Other Intervention Name(s)

Endocrine therapy

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Patient reported outcomes

Other Intervention Name(s)

surveys, questionnaires

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in participant preference for adjuvant radiation treatment

Description

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

Time Frame

up to 6 months

Title

Change in surgeon preference for adjuvant radiation treatment

Description

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

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Title

Illness perception as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS

Description

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

Time Frame

Through 24 months after start of adjuvant treatment period

Title

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

Description

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

Time Frame

Through 24 months after start of adjuvant treatment period

Title

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

Description

Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale.

Time Frame

Through 24 months after start of adjuvant treatment period

Title

Breast cancer beliefs as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS

Description

Breast cancer beliefs will be assessed using the UVA Breast Cancer Belief Survey, a novel series of questions regarding patient beliefs about breast cancer and breast cancer medications.

Time Frame

Through 24 months after start of adjuvant treatment period

Title

Treatment decision as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS.

Description

Time Frame

up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later

Title

Perceptions related to medical choices as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS.

Description

Subjects' perceptions related to their medical choices will be assessed using the Decisional Conflict Scale and the Decision Regret Scale.

Time Frame

Through 24 months after start of adjuvant treatment period

Title

Depression and anxiety as predictive measure for endocrine therapy adherence

Description

Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised.

Time Frame

Through 24 months after start of adjuvant treatment period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy B Smith

Phone

434-243-2770

ajb6bb@uvahealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shayna L Showalter, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olena Glushakova

Phone

434-409-6206

OYG2N@uvahealth.org

First Name & Middle Initial & Last Name & Degree

Linh-An Cao

Phone

434-297-7827

PBD2AM@uvahealth.org

First Name & Middle Initial & Last Name & Degree

Trish Millard, MD

Facility Name

Virginia Commonwealth University Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

Facility Contact:

ctoclinops@vcu.edu

First Name & Middle Initial & Last Name & Degree

Kandace P McGuire, MD FACS

12. IPD Sharing Statement

Learn more about this trial

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

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