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NCT05064085 · ClinicalTrials.gov registry record · Phase 1
Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer
A Phase 1 study of Hormone Receptor-Positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT05064085: Active Phase 1 study of Hormone Receptor-Positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT05064085 is a Phase 1 study of Hormone Receptor-Positive Breast Cancer that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 13 participants, below the 188-participant average among 23 other Hormone Receptor-Positive 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
NCT05064085, a Phase 1 study of Hormone Receptor-Positive Breast Cancer, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer.
Primary Outcome
Recommended Phase 2 dose of Capecitabine combined with Cemiplimab will be determined by testing 2 dose levels. RP2D reflects the highest dose that did not cause Dose Limiting Toxicity (DLT)
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG Capecitabine
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What the registry record for NCT05064085 still lists
NCT05064085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 188-participant average among 23 other Hormone Receptor-Positive Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Hormone Receptor-Positive Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.
NCT05064085 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05064085 about?
NCT05064085 is a clinical study titled "Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer". This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer.
What is the current status of trial NCT05064085?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-10-12. Estimated completion is 2026-09.
What conditions does trial NCT05064085 study?
This clinical trial studies the following conditions: Hormone Receptor-Positive Breast Cancer.
What interventions are being tested in trial NCT05064085?
The interventions under investigation include: Cemiplimab (DRUG), Capecitabine (DRUG).
Who is sponsoring clinical trial NCT05064085?
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 NCT05064085 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 Hormone Receptor-Positive 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 NCT05064085's enrollment target sits among peer trials
13 24th of 23 the lowest of 23 other Hormone Receptor-Positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hormone Receptor-Positive 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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