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Pilot Study of the Impact of a Combined Intermittent Fasting and Exercise Intervention on Metabolic Markers in Patients with Advanced, Hormone Receptor Positive Breast Cancer

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Trial ID:NCT04708860

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Protocol #:20-503

877-DF-TRIAL (877-338-7425)

Condition(s):Breast Cancer, Metastatic Breast Cancer

Phase:Feasibility / Pilot

Principal Investigator:Ligibel, Jennifer, A

Trial Description:
This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.

Eligibility Requirements:
- Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer
- Postmenopausal (including concurrent use of ovarian suppression)
- Initiating endocrine therapy in combination with:
- Cohort 1: alpelisib
- Cohort 2: palbociclib
- Self-reported ability to walk two blocks
- > 18 years of age
- Approval from treating oncologist, confirmed via email or in writing
- Ability to read and understand English
Exclusion Criteria:
- Diagnosis of diabetes requiring medication
- Engaging in >90 minutes of moderate or vigorous physical activity per week

Protocol #: 20-503

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