Clinical trial NCT04272801: Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Female
Keywords: breast cancer
endocrine therapy
radiation
letrozole
anastrozole
exemestane
tamoxifen
survey
questionnaire
geriatric
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 83
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot, 1 arm
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in participant preference for adjuvant radiation treatment
timeFrame: up to 6 months
measure: Change in surgeon preference for adjuvant radiation treatment
timeFrame: up to 6 months
Secondary outcomes:
measure: 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
timeFrame: Through 24 months after start of adjuvant treatment period
measure: 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
timeFrame: Through 24 months after start of adjuvant treatment period
measure: Illness perception as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS
timeFrame: Through 24 months after start of adjuvant treatment period
measure: 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
timeFrame: Through 24 months after start of adjuvant treatment period
measure: 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
timeFrame: Through 24 months after start of adjuvant treatment period
measure: 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
timeFrame: Through 24 months after start of adjuvant treatment period
measure: Treatment decision as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS.
timeFrame: up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later
measure: 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.
timeFrame: Through 24 months after start of adjuvant treatment period
measure: Depression and anxiety as predictive measure for endocrine therapy adherence
timeFrame: Through 24 months after start of adjuvant treatment period
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Massey Cancer Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Shayna L Showalter, MD
role: PRINCIPAL_INVESTIGATOR
References: