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

Protocol # :
Breast Cancer
Metastatic Breast Cancer
Feasibility / Pilot
Disease Sites
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

Inclusion Criteria:

- 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