Pre-Operative Window of ET to Inform RT Decisions (POWER II)

NCT06507618 | Recruiting Phase 3 DMC

• 1 other identifier: HSR230513
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 5

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).

Conditions

Breast Cancer Female

Keywords

breast cancer; endocrine therapy; radiation; letrozole; anastrozole; exemestane; tamoxifen; survey; questionnaire; geriatric

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Treatment with pre-ET and its impact on Decision Conflict

  24 months

• Treatment with pre-ET and its impact on Decision Regret

  24 months

• Assessing whether patient's final treatment correlates with their beliefs about breast cancer

  7 months

• Assessing whether patient's final treatment correlates with their beliefs about breast cancer

  7 months

• Assessing whether patient's final treatment correlates with their beliefs about breast cancer

  7 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

90 days of pre-ET (endocrine therapy - tamoxifen or aromatase inhibitor) before Breast Cancer Surgery

Drug: Tamoxifen, Letrozole, Anastrozole, or Exemestane

Control Arm

NO INTERVENTION

Will proceed directly to Breast Cancer Surgery

Interventions

Tamoxifen, Letrozole, Anastrozole, or Exemestane DRUG

Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.

Also known as: Endocrine Therapy

Intervention Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer and clinically negative nodes
• ECOG performance status 0-2
• Females, aged ≥ 65 years
• Patient is eligible for BCS and opted for BCS
• Patient is a candidate for radiation therapy
• Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
• Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS
• Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if:

• Bilateral synchronous breast cancer
• Multicentric disease
• Prior use of Tamoxifen 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (5)

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

University of Virginia Community Health

Culpeper, Virginia, 22701, United States

RECRUITING

INOVA Schar Cancer

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Letrozole; Anastrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shayna L Showalter, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meagan Miller

CONTACT

434-243-8101; aey8fc@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 18, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): March 1, 2034
• Last Updated: May 8, 2026

Record last verified: 2026-02

Locations

US (5)