Breast Cancer FemalePhase 2POWERNCT04272801
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer
A Phase 2 study testing tamoxifen, letrozole, anastrozole, or exemestane and Patient reported outcomes in people with Breast Cancer Female, run by Shayna Showalter, MD at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- tamoxifen, letrozole, anastrozole, or exemestane and Patient reported outcomes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2020to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22908
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions In Older Women With Early-Stage Breast Cancer
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).
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- tamoxifen, letrozole, anastrozole, or exemestane, Patient reported outcomes
- Keywords
- breast cancer, endocrine therapy, radiation, letrozole, anastrozole, exemestane, tamoxifen, survey, questionnaire, geriatric
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifen, letrozole, anastrozole, or exemestaneDrug
Also called Endocrine therapy
choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist
Patient reported outcomesBehavioural
Also called surveys, questionnaires
Questionnaire inquiries include the following:
- how cancer affects daily living
- beliefs about medicines and sensitivity to medicine
- symptoms
- adherence to endocrine therapy
- general health and well being
- depression and anxiety
- preference regarding radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative endocrine therapy | Experimental | 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. Receives: Drug: tamoxifen, letrozole, anastrozole, or exemestane; Behavioral: Patient reported outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment
Change in participant response to question regarding preference for adjuvant radiation treatment
Measured: up to 6 months
Change in Surgeon Preference for Adjuvant Radiation Treatment
Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment
Measured: up to 6 months
Secondary outcomes (9)
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
Health related quality of life will be assessed using the EORTC QLQ-C30 and QLQ-BR23.
Measured: Through 24 months after start of adjuvant treatment period
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
General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist.
Measured: Through 24 months after start of adjuvant treatment period
Illness Perception as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
Illness perception will be assessed using the Brief Illness Perception Questionnaire.
Measured: Through 24 months after start of adjuvant treatment period
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
Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire.
Measured: Through 24 months after start of adjuvant treatment period
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
Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale.
Measured: Through 24 months after start of adjuvant treatment period
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
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.
Measured: Through 24 months after start of adjuvant treatment period
Treatment Decision as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS.
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.
Measured: up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later
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.
Subjects' perceptions related to their medical choices will be assessed using the Decisional Conflict Scale and the Decision Regret Scale.
Measured: Through 24 months after start of adjuvant treatment period
Depression and Anxiety as Predictive Measure for Endocrine Therapy Adherence
Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised.
Measured: Through 24 months after start of adjuvant treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start7 Apr 2020
- Primary completion5 Jun 2024
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, 1 arm
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shayna Showalter, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Shayna Showalter, MD, University of Virginia
- Investigators
- Shayna L Showalter, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272801
- Sponsor's protocol ID
- 22040
- Other IDs
- 5R21CA277311-02
- Acronym
- POWER
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2020
- Last updated
- 22 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions In Older Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04272801
- Acronym / sponsor ID
- POWER / 22040
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer, endocrine therapy, radiation, letrozole, anastrozole, exemestane, tamoxifen, survey
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shayna Showalter, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 22 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, 1 arm
| Arm | Type | Receives |
|---|---|---|
| Pre-operative endocrine therapy | Experimental | Drug: tamoxifen, letrozole, anastrozole, or exemestane, Behavioral: Patient reported outcomesAll 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamoxifen, letrozole, anastrozole, or exemestaneAlso: Endocrine therapychoice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist | Drug | Pre-operative endocrine therapy |
| Patient reported outcomesAlso: surveys, questionnairesQuestionnaire inquiries include the following: * how cancer affects daily living * beliefs about medicines and sensitivity to medicine * symptoms * adherence to endocrine therapy * general health and well being * depression and anxiety * preference regarding radiation therapy | Behavioural | Pre-operative endocrine therapy |
Primary outcome
Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment
Time frame: up to 6 months
Change in participant response to question regarding preference for adjuvant radiation treatment
Change in Surgeon Preference for Adjuvant Radiation Treatment
Time frame: up to 6 months
Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment
9 secondary outcomes
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
Time frame: Through 24 months after start of adjuvant treatment period
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
Time frame: Through 24 months after start of adjuvant treatment period
Illness Perception as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
Time frame: Through 24 months after start of adjuvant treatment period
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
Time frame: Through 24 months after start of adjuvant treatment period
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
Time frame: Through 24 months after start of adjuvant treatment period
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
Time frame: Through 24 months after start of adjuvant treatment period
Treatment Decision as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS.
Time frame: up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later
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.
Time frame: Through 24 months after start of adjuvant treatment period
Depression and Anxiety as Predictive Measure for Endocrine Therapy Adherence
Time frame: Through 24 months after start of adjuvant treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shayna L Showalter, MD principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tamoxifen, letrozole, anastrozole, or exemestane and Patient reported outcomes in people with Breast Cancer Female, run by Shayna Showalter, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.