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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 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.

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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.

Interventions

  • DRUG Cemiplimab
  • DRUG Capecitabine

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-10-12
Est. Completion 2026-09
Phase Phase 1

What the Registry Record Tells You About NCT05064085

The ClinicalTrials.gov registry entry for NCT05064085 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 188-participant average among 23 other Hormone Receptor-Positive Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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