Fasting and Exercise for Women with 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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
260 (estimated)
Sponsor
University of Miami · Other
Who this trial is looking for
This trial is looking for women with advanced breast cancer to test if fasting, exercise, or health education can help reduce fatigue. Participants will be grouped into different programs to see which one is best.
Are You a Good Fit for This Trial?
Must be takingCDK4/6 inhibitor
Rules you outSevere medical conditionSevere psychiatric condition
You may be able to join if
I am a woman
I can give written consent
I speak and understand English or Spanish
I am postmenopausal
I have advanced breast cancer that is hormone receptor positive
I started treatment with a CDK4/6 inhibitor within the last 90 days
I haven't regularly exercised or fasted over the last 3 months
My doctor approves my participation
You may not be able to join if
I cannot provide consent
I cannot read or understand English or Spanish
I am oxygen dependent
I have unstable heart disease
I have insulin-dependent diabetes
I can't walk 2 blocks without help
I have a history of eating disorders
I have unstable bone metastases
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT inhibitor.
Trial Locations
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Eligibility Criteria
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…
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 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) or Protein kinase B (AKT) inhibitor, within the past 90 days.
a) 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 subsequent 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
9. Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months
10. Approval from a medical oncology provider to participate.
Exclusion Criteria:
1. Unable to provide consent
2. Unable to read or understand English or Spanish
3. Dependent on supplemental oxygen
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 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/AKT inhibitor, in the metastatic or locally advanced.
11. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.
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