Pre-Operative Window of ET to Inform RT Decisions (POWER II)
- Conditions
- Breast Cancer Female
- Interventions
- Drug: Tamoxifen, Letrozole, Anastrozole, or Exemestane
- Registration Number
- NCT06507618
- Lead Sponsor
- University of Virginia
- Brief 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).
- Detailed Description
Early-stage, estrogen receptor positive (ER+) breast cancer is traditionally treated with breast conserving surgery (BCS), radiation therapy (RT) and 5-10 years of adjuvant endocrine therapy (AET). Radiation therapy (RT) omission is an established treatment paradigm for women 65 years and older with ER+, node negative, small (≤ 3 cm) breast cancer. Despite the option for RT omission being recommended in the National Comprehensive Cancer Network (NCCN) guidelines, multiple modern studies demonstrate that a majority of older women still receive RT, raising concern for over-treatment. Conversely, there are a portion of patients who choose to omit RT but are not able to tolerate AET and thus are at risk for under-treatment and worse oncologic outcomes.
In the POWER I trial, patients were treated with 90 days of pre-operative endocrine therapy (pre-ET) as a window to establish endocrine therapy (ET) tolerance. The POWER I trial prospectively validated 90 days of pre-operative ET to determine if it could be used as a tool to inform adjuvant RT decisions and recommendations by patients and physicians respectively. Ninety days of pre-ET was shown to influence patient and physician preferences regarding adjuvant RT.
In the POWER II trial, participants will be randomized to treatment on either a) an intervention arm consisting of a 90-day window of pre-ET or b) the standard of care (control) arm in which participants proceed directly to BCS. In both arms, the decision to omit or administer adjuvant RT will be made by the treating physicians and patients. While not required per protocol, all patients will be recommended for AET if deemed appropriate by their oncologist, and adherence through 2 years will be monitored. The POWER I study revealed that pre-ET impacts patients' and physicians' decisions regarding adjuvant therapy and facilitates adjuvant therapy decisions that meld patient preferences and side effect tolerance. The purpose of the POWER II study is to examine whether 90 days of pre-ET results in a decrease in the number of (1) patients being treated with BCS alone and (2) patients treated with BCS+RT+AET. Adherence to AET will be defined as taking AET at 2 years post-BCS.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 354
Not provided
- Bilateral synchronous breast cancer
- Multicentric disease
- Prior use of SERMS or aromatase inhibitors
- History of ipsilateral breast radiation therapy
- Has a known additional malignancy that is progressing and/or requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.
- Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Tamoxifen, Letrozole, Anastrozole, or Exemestane 90 days of pre-ET (endocrine therapy - tamoxifen or aromatase inhibitor) before Breast Cancer Surgery
- Primary Outcome Measures
Name Time Method Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET) 24 months Proportion of participants who omit RT and are non-adherent to ET as measure through the 24-month adjuvant follow-up visit
Proportion of participants who are treated with Breast Cancer Surgery (BCS) + RT + AET 24 months Proportion of participants who are treated with BCS + RT + AET as measured through the 24-month adjuvant follow-up visit
- Secondary Outcome Measures
Name Time Method To obtain data on regional recurrence 5 years Regional recurrence as measured through the 5 year adjuvant follow-up period
Treatment with pre-ET and its impact on Decision Conflict 24 months 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.
Treatment with pre-ET and its impact on Decision Regret 24 months 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).
Assessing whether patient's final treatment correlates with their beliefs about breast cancer 7 months 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.
Assessing whether treatment with pre-ET leads to improved Health Related Quality of Life compared to those treated with standard of care 24 months 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
Assessing whether early side effects of ET correlate with patient treatment group within study arms 24 months 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
To obtain data on local recurrence 5 years Local recurrence as measured through the 5 year adjuvant follow-up period
To obtain data on contralateral breast cancer 5 years Contralateral breast cancer as measured through the 5 year adjuvant follow-up period
To obtain data on distant metastases 5 years Distant metastases as measured through the 5 year adjuvant follow-up period
To obtain data on disease free survival 5 years Disease free survival (DFS) as measured through the 5 year adjuvant follow-up period
To obtain data on overall survival 5 years Overall survival (OS) as measured through the 5 year adjuvant follow-up period
To obtain data on cancer specific survival 5 years Cancer specific survival as measured through the 5 year adjuvant follow-up period
Trial Locations
- Locations (2)
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States