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NCT06691035 · ClinicalTrials.gov registry record · Phase 1
Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
A Phase 1 study of HER2-Negative Breast Cancer and Breast Cancer Metastatic Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06691035: Recruiting Phase 1 study of HER2-Negative Breast Cancer and Breast Cancer Metastatic Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06691035 is a Phase 1 study of HER2-Negative Breast Cancer and Breast Cancer Metastatic Breast Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 18 participants, below the 255-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06691035, a Phase 1 study of HER2-Negative Breast Cancer and Breast Cancer Metastatic Breast Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.
Primary Outcome
Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (8 weeks) to End of Treatment (EOT) (window of + 30 days from date of last study treatment). Data collection will include rate of successful completion.
Conditions Studied
Interventions
- DRUG Elacestrant
- BIOLOGICAL DC1 native/mutated ESR1
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
What NCT06691035 shows while recruiting
NCT06691035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 255-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Elacestrant is the first listed.
NCT06691035 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06691035 about?
NCT06691035 is a clinical study titled "Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer". This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.
What is the current status of trial NCT06691035?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-11-04. Estimated completion is 2027-11.
What conditions does trial NCT06691035 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer, Breast Cancer Metastatic Breast Cancer.
What interventions are being tested in trial NCT06691035?
The interventions under investigation include: Elacestrant (DRUG), DC1 native/mutated ESR1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06691035?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06691035 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-Negative Breast Cancer
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 NCT06691035's enrollment target sits among peer trials
18 45th of 49 higher than 5 of 49 other HER2-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Negative 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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