Trial ID:NCT04708860
Protocol #:20-503
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