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Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu

RecruitingPhase 2

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Subject aged ≥ 18 years
* Diagnosis of locally advanced/unresectable or metastatic breast cancer. Note: Patients with High-Risk HER-2 + breast cancer after completion of neoadjuvant chemotherapy requiring adjuvant Enhertu are allowed at the discretion of the treating physician.
* Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks. Note: HER-2 targeted systemic therapy (e.g. Trastuzumab and/or Pertuzumab) in conjunction with Enhertu is allowed.
* Able and willing to participate in the interventional aerobic exercise and resistance exercises.
* Currently following standard of care contraception requirements and willing to continue following these requirements for the duration of therapy.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
* Experiencing clinical fatigue symptoms in the opinion of the investigator.
* Subject has completed the ACSM exercise preparticipation health screening and is, in the opinion of the investigator, fit to participate in this study.

Exclusion Criteria:

-Currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training ≥ two days per week.

* Structured is defined as time set aside in the subject's day to workout.
* Resistance training is defined as exercises which use weights, bands, or body weight (e.g., squats or push-ups).

AND Currently participating in structured moderate-intensity aerobic exercise for ≥ 150 minutes per week.

* Moderate-intensity exercise is defined as activities where the subject can talk but not sing.
* Aerobic exercise includes, but is not limited to, walking, swimming, cycling, running, rowing, hiking, and elliptical.

  * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
  * Participants taking prohibited medications as described in Section 7.4.1.

About the study

The goal of this study is to test the efficacy of using a 12-week, home-based, unsupervised aerobic and resistance training exercise program for changes in cancer-related fatigue in patients with metastatic breast cancer who are receiving Enhertu.

What is being tested

Sponsor: University of Utah · Participants: 80 · Started: Nov 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07203378

Locations in the U.S.

UtahHuntsman Cancer Institute at University of Utah, Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.