Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer
- Conditions
- Breast Cancer Female
- Interventions
- Drug: tamoxifen, letrozole, anastrozole, or exemestaneBehavioral: Patient reported outcomes
- Registration Number
- NCT04272801
- Lead Sponsor
- Shayna Showalter, MD
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 83
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre-operative endocrine therapy tamoxifen, letrozole, anastrozole, or exemestane 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. Pre-operative endocrine therapy Patient reported outcomes 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.
- Primary Outcome Measures
Name Time Method Change in participant preference for adjuvant radiation treatment up to 6 months Change in participant response to question regarding preference for adjuvant radiation treatment
Change in surgeon preference for adjuvant radiation treatment up to 6 months Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment
- Secondary Outcome Measures
Name Time Method 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 Through 24 months after start of adjuvant treatment period General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist.
Depression and anxiety as predictive measure for endocrine therapy adherence Through 24 months after start of adjuvant treatment period Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised.
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 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.
Illness perception as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS Through 24 months after start of adjuvant treatment period 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 Through 24 months after start of adjuvant treatment period Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire.
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 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.
Treatment decision as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS. 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.
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 Through 24 months after start of adjuvant treatment period Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale.
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. 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.
Trial Locations
- Locations (2)
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
University of Virginia🇺🇸Charlottesville, Virginia, United States