Clinical Trials /

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

NCT04272801

Description:

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.

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04272801

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Endocrine Therapy Tolerance in Geriatric Early Stage ER+ Breast Cancer
  • Official Title: A Pilot Study Of Neoadjuvant Endocrine Therapy Tolerance To Inform Treatment Decisions For Adjuvant Radiation In Geriatric, Early Stage ER+ Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 22040
  • NCT ID: NCT04272801

Conditions

  • Breast Cancer Female

Interventions

DrugSynonymsArms
tamoxifen, letrozole, anastrozole, or exemestaneEndocrine therapyNeoadjuvant endocrine therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Neoadjuvant endocrine therapyExperimentalAll 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.
  • tamoxifen, letrozole, anastrozole, or exemestane

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
Maximum Eligible Age:N/A
Minimum Eligible Age:65 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in participant preference for adjuvant radiation treatment
Time Frame:up to 6 months
Safety Issue:
Description:Change in participant response to question regarding preference for adjuvant radiation treatment

Secondary Outcome Measures

Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
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. 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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Trish Millard, MD

Trial Keywords

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

Last Updated

June 22, 2021