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NCT04298086 · ClinicalTrials.gov registry record · Phase 2
A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
A Phase 2 study of Breast Cancer and Primary Hormone Receptor Positive Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 7
- Study locations
NCT04298086: Active Phase 2 study of Breast Cancer and Primary Hormone Receptor Positive Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04298086 is a Phase 2 study of Breast Cancer and Primary Hormone Receptor Positive Breast Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 43 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04298086, a Phase 2 study of Breast Cancer and Primary Hormone Receptor Positive Breast Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.
Primary Outcome
Will explore the data using descriptive statistics and graphical methods, such as summarizing the aromatase levels at baseline and at 24 weeks using means and medians and plotting the data to visualize changes over time. To compare the aromatase levels at 24 weeks post-intervention between the groups, an analysis of covariance (ANCOVA) model will be used.
Conditions Studied
Interventions
- OTHER Physical activity
- OTHER Exercise Treatment
- OTHER Plant-Based Diet
- OTHER Nutrition counseling
- OTHER Replication Exercise Test
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2020-03-04 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What the registry record for NCT04298086 still lists
NCT04298086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Physical activity is the first listed.
NCT04298086 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04298086 about?
NCT04298086 is a clinical study titled "A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer". The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may a...
What is the current status of trial NCT04298086?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2020-03-04. Estimated completion is 2026-03.
What conditions does trial NCT04298086 study?
This clinical trial studies the following conditions: Breast Cancer, Primary Hormone Receptor Positive Breast Cancer.
What interventions are being tested in trial NCT04298086?
The interventions under investigation include: Physical activity (OTHER), Exercise Treatment (OTHER), Plant-Based Diet (OTHER), Nutrition counseling (OTHER), Replication Exercise Test (OTHER).
Who is sponsoring clinical trial NCT04298086?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04298086 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04298086's enrollment target sits among peer trials
43 855th of 1224 higher than 362 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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