Pre-Operative Window of ET to Inform RT Decisions (POWER II)
NCT Number: NCT06507618
Acronym: POWER II
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Breast Cancer Female
Interventions: DRUG: Tamoxifen, Letrozole, Anastrozole, or Exemestane
Sponsor: University of Virginia
Sex: FEMALE
Age: OLDER_ADULT
Enrollment: 354
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2034-03-01
Locations: University of Virginia, Charlottesville, Virginia, 22903, United States

Summary:
This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups:

Intervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.

Both arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).

Primary Outcome Measures: Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET), Proportion of participants who omit RT and are non-adherent to ET as measure through the 24-month adjuvant follow-up visit, 24 months|Proportion of participants who are treated with Breast Cancer Surgery (BCS) + RT + AET, Proportion of participants who are treated with BCS + RT + AET as measured through the 24-month adjuvant follow-up visit, 24 months
Secondary Outcome Measures: Treatment with pre-ET and its impact on Decision Conflict, Using Patient Reported Outcomes (PRO) assessments of Decisional Conflict Scale (DCS) to determine whether treatment with pre-ET lessens Decision Conflict. The DCS is a validated measure of patient perceptions of uncertainty surrounding treatment choices. The minimum score is a 0, which is interpreted as no decisional conflict, and the maximum score is 64, which is interpreted as the highest decisional conflict., 24 months|Treatment with pre-ET and its impact on Decision Regret, Using Patient Reported Outcomes (PRO) assessments of Decision Regret Scale (DRS) to determine whether treatment with pre-ET lessens Decision Regret. The DRS is a validated, 5-item scale that measures self-reported regret after health care decisions. DRS scores range from 0 (no regret) to 100 (high regret)., 24 months|Assessing whether patient's final treatment correlates with their beliefs about breast cancer, Using the PRO assessment "Beliefs about Illness Questionnaire (BIP-Q)" to determine patient's beliefs about breast cancer. The BIP-Q is a validated survey to assess cognitive and emotional perceptions of illness., 7 months|Assessing whether patient's final treatment correlates with their beliefs about breast cancer, Using the PRO assessment "Beliefs about Medicine Questionnaire (BMQ)" to determine patient's beliefs about breast cancer. The BMQ is a validated survey designed to capture patients' perceptions about medicines and medicine adherence., 7 months|Assessing whether patient's final treatment correlates with their beliefs about breast cancer, Using the PRO assessment "Perceived Sensitivity to Medicine (PSM)" to determine patient's beliefs about breast cancer. The PSM is a validated 5-question survey designed to capture patients' opinions regarding their sensitivity to medications., 7 months|Assessing whether treatment with pre-ET leads to improved Health Related Quality of Life compared to those treated with standard of care, Using PRO Assessments: EORTC Quality of Life questionnaires (QLQ-C30) to determine whether treatment with pre-ET leads to improved health-related quality of life compared to those treated with standard of care, 24 months|Assessing whether early side effects of ET correlate with patient treatment group within study arms, Using the PRO Assessment "Breast Cancer Prevention Trial Symptom Checklist (BCPT-SCL)" to assess whether early side effects of ET correlate with patient treatment group within study arms, 24 months|Assessing whether early side effects of ET correlate with patient treatment group within study arms, Using the PRO Assessment "Center for Epidemiologic Study Depression Scale Revised (CESD-R)" to assess whether early side effects of ET correlate with patient treatment group within study arms, 24 months|To obtain data on local recurrence, Local recurrence as measured through the 5 year adjuvant follow-up period, 5 years|To obtain data on regional recurrence, Regional recurrence as measured through the 5 year adjuvant follow-up period, 5 years|To obtain data on contralateral breast cancer, Contralateral breast cancer as measured through the 5 year adjuvant follow-up period, 5 years|To obtain data on distant metastases, Distant metastases as measured through the 5 year adjuvant follow-up period, 5 years|To obtain data on disease free survival, Disease free survival (DFS) as measured through the 5 year adjuvant follow-up period, 5 years|To obtain data on cancer specific survival, Cancer specific survival as measured through the 5 year adjuvant follow-up period, 5 years|To obtain data on overall survival, Overall survival (OS) as measured through the 5 year adjuvant follow-up period, 5 years