Breast Cancer Trial, Recruiting NCT06123988 Sponsor: University of Miami Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT06123988
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who identify as women
  • People who are able to give written consent to participate
  • People who can speak, read, and understand English or Spanish
  • People who are post-menopausal, including those whose ovaries have been medically suppressed
  • People who have been diagnosed with a specific type of advanced or metastatic breast cancer that is hormone receptor-positive (ER+ and/or PR+), regardless of HER-2 status
  • People who have started a first or second course of hormone-based therapy combined with a CDK4/6 inhibitor (such as palbociclib, ribociclib, or abemaciclib), with or without certain targeted HER2 therapies, within the past 90 days — previous use of a CDK4/6 inhibitor in an earlier stage of treatment is allowed, and switching between CDK4/6 inhibitors due to side effects or insurance reasons does not disqualify someone, provided enrollment happens within 90 days of starting the relevant treatment (confirm with trial site)
  • People who have not regularly done more than 90 minutes of moderate exercise or 45 minutes of vigorous exercise per week for the past 3 months (where "regularly" means at least half the time)
  • People who have not regularly done resistance or strength training 2 or more days per week over the past 3 months
  • People who have not regularly followed a fasting routine of 12 hours or more overnight for the past 3 months (where "regularly" means at least half the time)
  • People whose cancer specialist (medical oncologist) has approved their participation

Who may not be able to join:

  • People who are unable to give informed consent
  • People who cannot read or understand English or Spanish
  • People who require oxygen to breathe
  • People with unstable heart disease
  • People who require insulin to manage diabetes
  • People who are unable to walk 2 blocks without assistance (note: use of a cane does not disqualify someone)
  • People who have worked evening, night, or rotating shifts regularly in the past 3 months
  • People with a history of a clinically diagnosed eating disorder
  • People with unstable spread of cancer to the bones
  • People for whom more than 90 days have passed since starting the qualifying hormone therapy and CDK4/6 inhibitor combination in the advanced or metastatic setting
  • People with a serious medical or psychiatric condition, or who take medications, that would prevent safe participation in the study activities (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Tracy E Crane, PhD, RDN, University of Miami

Phone: (305) 243-9832

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
9 September 2024
Est. completion
30 September 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov