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Neoadjuvant Endocrine Therapy Tolerance in Geriatric Early Stage ER+ Breast Cancer (Breast52)

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ClinicalTrials.gov Identifier: NCT04272801
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Trish Millard, MD, University of Virginia

Brief Summary:
This single arm pilot study evaluates the use of neoadjuvant 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 neoadjuvant endocrine therapy helps inform decisions on whether or not to omit radiation. Participants will be treated with the novel approach of 3 months of neoadjuvant 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

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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: A Pilot Study Of Neoadjuvant Endocrine Therapy Tolerance To Inform Treatment Decisions For Adjuvant Radiation In Geriatric, Early Stage ER+ Breast Cancer
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : October 7, 2023
Estimated Study Completion Date : June 7, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Neoadjuvant endocrine therapy
All participants enrolled to the study will receive 3 months of neoadjuvant 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

Questionnaires inquire:

  • 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




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 [ Time Frame: Neoadjuvant endocrine therapy Days 1, 30, 90, and adjuvant treatment period post BCS/RT day 14, months 6, 12, & 24 ]
    Health related quality of life will be assessed using the EORTC QLQ-C30 and QLQ-BR23. Logistic regression models with adherence to post-op endocrine therapy at 2 years as the dependent outcome and the range of measurement as independent factors will be used to estimate the association of pre-treatment responses on the probability of long-term adjuvant endocrine therapy adherence.

  2. Depression and anxiety as predictive measure for endocrine therapy adherence [ Time Frame: Neoadjuvant endocrine therapy Days 1, 30, 90, and adjuvant treatment period post BCS/RT day 14, months 6, 12, & 24 ]
    Depression and anxiety will be assessed using the Hospital and Depression Scale. Logistic regression models with adherence to post-op endocrine therapy at 2 years as the dependent outcome and the range of measurement as independent factors will be used to estimate the association of pre-treatment responses on the probability of long-term adjuvant endocrine therapy adherence.

  3. General symptom burden as predictive measure for endocrine therapy adherence [ Time Frame: Neoadjuvant endocrine therapy Days 1, 30, 90, and adjuvant treatment period post BCS/RT day 14, months 6, 12, & 24 ]
    General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist. Logistic regression models with adherence to post-op endocrine therapy at 2 years as the dependent outcome and the range of measurement as independent factors will be used to estimate the association of pre-treatment responses on the probability of long-term adjuvant endocrine therapy adherence.

  4. Illness perception as predictive measure for endocrine therapy adherence [ Time Frame: Neoadjuvant endocrine therapy Days 1, 30, 90, and adjuvant treatment period post BCS/RT day 14, months 6, 12, & 24 ]
    Illness perception will be assessed using the Brief Illness Perception Questionnaire. Logistic regression models with adherence to post-op endocrine therapy at 2 years as the dependent outcome and the range of measurement as independent factors will be used to estimate the association of pre-treatment responses on the probability of long-term adjuvant endocrine therapy adherence.

  5. Beliefs about medicine as predictive measure for endocrine therapy adherence [ Time Frame: Neoadjuvant endocrine therapy Days 1, 30, 90, and adjuvant treatment period post BCS/RT day 14, months 6, 12, & 24 ]
    Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire. Logistic regression models with adherence to post-op endocrine therapy at 2 years as the dependent outcome and the range of measurement as independent factors will be used to estimate the association of pre-treatment responses on the probability of long-term adjuvant endocrine therapy adherence.

  6. Perceived sensitivity to medicine as predictive measure for endocrine therapy adherence [ Time Frame: Neoadjuvant endocrine therapy Days 1, 30, 90, and adjuvant treatment period post BCS/RT day 14, months 6, 12, & 24 ]
    Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale. Logistic regression models with adherence to post-op endocrine therapy at 2 years as the dependent outcome and the range of measurement as independent factors will be used to estimate the association of pre-treatment responses on the probability of long-term adjuvant endocrine therapy adherence.

  7. Breast cancer beliefs as predictive measure for endocrine therapy adherence [ Time Frame: Neoadjuvant endocrine therapy Days 1, 30, 90, and adjuvant treatment period post BCS/RT day 14, months 6, 12, & 24 ]
    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. Logistic regression models with adherence to post-op endocrine therapy at 2 years as the dependent outcome and the range of measurement as independent factors will be used to estimate the association of pre-treatment responses on the probability of long-term adjuvant endocrine therapy adherence.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272801


Contacts
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Contact: Olena Glushakova (434)409-6206 OYG2N@hscmail.mcc.virginia.edu
Contact: Stephen Hazen 434-297-7827 seh3aa@virginia.edu

Locations
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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   
Sponsors and Collaborators
Trish Millard, MD
Investigators
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Principal Investigator: Trish Millard, MD University of Virginia
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Responsible Party: Trish Millard, MD, Primary Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT04272801    
Other Study ID Numbers: 22040
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021

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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 Trish Millard, MD, University of Virginia:
breast cancer
endocrine therapy
radiation
letrozole
anastrozole
exemestane
tamoxifen
survey
questionnaire
geriatric
Additional relevant MeSH terms:
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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