Neoadjuvant Endocrine Therapy Tolerance in Geriatric Early Stage ER+ Breast Cancer (POWER)

• ClinicalTrials.gov Identifier: NCT04272801
• Recruitment Status: Recruiting
• First Posted: February 17, 2020
• Last Update Posted: March 31, 2022
• Sponsor: Shayna Showalter, MD
• Information provided by (Responsible Party): Shayna Showalter, MD, University of Virginia

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Female	Drug: tamoxifen, letrozole, anastrozole, or exemestane; Behavioral: Patient reported outcomes	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 83 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot, 1 arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions In Older Women With Early-Stage Breast Cancer
• Actual Study Start Date: April 7, 2020
• Estimated Primary Completion Date: October 7, 2023
• Estimated Study Completion Date: June 7, 2025

Arms and Interventions

Arm

Intervention/treatment

Experimental: Pre-operative endocrine therapy; 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; choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist; Other Name: Endocrine therapy; 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; Other Name: surveys, questionnaires

Outcome Measures

Primary Outcome Measures :

1. Change in participant preference for adjuvant radiation treatment [ Time Frame: up to 6 months ]
   Change in participant response to question regarding preference for adjuvant radiation treatment
2. Change in surgeon preference for adjuvant radiation treatment [ Time Frame: up to 6 months ]
   Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment

Secondary Outcome Measures :

1. 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 [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   Health related quality of life will be assessed using the EORTC QLQ-C30 and QLQ-BR23.
2. 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 [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist.
3. Illness perception as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   Illness perception will be assessed using the Brief Illness Perception Questionnaire.
4. 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 [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire.
5. 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 [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale.
6. 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 [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   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.
7. Treatment decision as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS. [ Time Frame: up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later ]
   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.
8. 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. [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   Subjects' perceptions related to their medical choices will be assessed using the Decisional Conflict Scale and the Decision Regret Scale.
9. Depression and anxiety as predictive measure for endocrine therapy adherence [ Time Frame: Through 24 months after start of adjuvant treatment period ]
   Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Olena Glushakova; (434)409-6206; OYG2N@hscmail.mcc.virginia.edu

Contact: Stephen Hazen; 434-297-7827; seh3aa@virginia.edu

Locations

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22908

Contact: Olena Glushakova 434-409-6206 OYG2N@hscmail.mcc.virginia.edu

Contact: Stephen Hazen 434-297-7827 seh3aa@virginia.edu

Principal Investigator: Trish Millard, MD

Virginia Commonwealth University Massey Cancer Center; Not yet recruiting

Richmond, Virginia, United States, 23298

Principal Investigator: Kandace P McGuire, MD FACS

Sponsors and Collaborators

Shayna Showalter, MD

Investigators

• Principal Investigator: Shayna L Showalter, MD; University of Virginia

More Information

• Responsible Party: Shayna Showalter, MD, Sponsor-Investigator, University of Virginia
• ClinicalTrials.gov Identifier: NCT04272801
• Other Study ID Numbers: 22040
• First Posted: February 17, 2020
• Last Update Posted: March 31, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Shayna Showalter, MD, University of Virginia:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Tamoxifen; Letrozole; Anastrozole; Exemestane; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Bone Density Conservation Agents