Recruiting
Phase 3

POWER II

Sponsor:

University of Virginia

Code:

NCT06507618

Conditions

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Tamoxifen, Letrozole, Anastrozole, or Exemestane

Study Details

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

Study ID

NCT06507618

Start date

Jul 19, 2024

Status verified date

Feb, 2026

Completion date

Mar 1, 2034

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria (summary):

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

354 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

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

no intervention: Control Arm

Will proceed directly to Breast Cancer Surgery

Interventions

Tamoxifen, Letrozole, Anastrozole, or Exemestane

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

Primary outcome measure

  • Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET) [ Time Frame: 24 months ]
  • Proportion of participants who are treated with Breast Cancer Surgery (BCS) + RT + AET [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Meagan Miller

434-243-8101aey8fc@uvahealth.org

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Cameron Groshek

8604161250cameron.groshek@yale.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Meagan Miller

(434) 243-8101aey8fc@uvahealth.org

University of Virginia Community Health

Recruiting

Culpeper, Virginia, United States, 22701

Contacts

Ali Mahjoub

AM3CG@uvahealth.org

INOVA Schar Cancer

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Shawna Willey

5714724724

Riverside Health System

Recruiting

Newport News, Virginia, United States, 23601

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Deja Wortham

worthamdn@vcu.edu

More Information

Sponsor

University of Virginia

Last update posted

Jun 30, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-06-30.