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Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGNA

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer (FastER)

NCT06123988•University of Miami

View on ClinicalTrials.gov

Summary

The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without HER2-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a PI3K inhibitor, within the past 90 days.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Women
•2. Able to provide written informed consent
•3. Able to speak, read, and understand English or Spanish
•4. Postmenopausal (including concurrent use of ovarian suppression)
•5. Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer
•6. Initiation of first-line or second-line endocrine therapy in combination with a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without hormone estrogen receptor-2 (HER2)-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a Phosphoinositide 3-kinase (PI3K) inhibitor, within the past 90 days.
•1. Prior use of a CDK4/6 inhibitor in the adjuvant setting is permitted; participants must be enrolled within 90 days of starting a CDK4/6 inhibitor for the first or second time in the metastatic or locally advanced setting.
•2. Participants who switch from one CDK4/6 inhibitor to another due to toxicity or insurance constraints remain eligible, provided enrollment occurs within 90 days of initiating the first or second-line CDK4/6 inhibitor in the metastatic or locally advanced setting.
•7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
•8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
+2 more criteria

Exclusion Criteria

•1. Unable to provide consent
•2. Unable to read or understand English or Spanish
•3. Oxygen dependent
•4. Unstable cardiac disease
•5. Insulin-dependent diabetes
•6. Unable to walk 2 blocks without assistance (excluding canes)
•7. Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
•8. History of a clinical eating disorder
•9. Unstable bone metastases
•10. More than 90 days since initiation of first- or second-line endocrine therapy in combination with 1) a CDK4/6 inhibitor, with or without HER2-directed therapy, or 2) a CDK 4/6 inhibitor in combination with a PI3K inhibitor, in the metastatic or locally advanced.
+1 more criteria

Locations (3)

Arizona State University

Phoenix, Arizona, United States

University of Miami

Miami, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

September 9, 2024

Primary Completion Date

September 30, 2028

Completion Date

September 30, 2029

Last Updated

August 6, 2025

Enrollment

260

ESTIMATED participants

Conditions

HER2-positive Breast CancerAdvanced Breast Cancer

Interventions

Prolonged Overnight Fasting

BEHAVIORAL

Moderate-Intensity Exercise

BEHAVIORAL

General Health Education Sessions

BEHAVIORAL

Contacts

Grey Freylersythe, BS

CONTACT

(305) 243-9832 g.freylersythe@med.miami.edu

Tracy E Crane, PhD, RDN

CONTACT

(305) 243-8255 tecrane@med.miami.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Study of Surgery and Radiotherapy in People With Breast Cancer