Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03962647 · ClinicalTrials.gov registry record · Early Phase 1
A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer
A Early Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 31
- Enrollment target
NCT03962647: Completed Early Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT03962647 is a Early Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 31 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03962647, a Early Phase 1 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.
Primary Outcome
The number of patients who complete the dietary intervention, as well as the reasons for early discontinuation and any adverse events will be reported. The number of of cases where pre- and post-treatment samples could be obtained and successfully analyzed for Ki67 and insulin signaling will also be reported.
Interventions
- DRUG Letrozole
- DIETARY_SUPPLEMENT 2-Week Ketogenic Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2024-07-14 |
| Phase | Early Phase 1 |
What the finished NCT03962647 record still lists
NCT03962647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Letrozole is the first listed.
NCT03962647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03962647 about?
NCT03962647 is a clinical study titled "A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer". This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.
What is the current status of trial NCT03962647?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 31 participants. The study started on 2019-07-08. Estimated completion is 2024-07-14.
What interventions are being tested in trial NCT03962647?
The interventions under investigation include: Letrozole (DRUG), 2-Week Ketogenic Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03962647?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03962647's enrollment target sits among peer trials
31 794th of 2000 higher than 1,195 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI