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Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer

NCT05064085 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-04-06

No results posted yet for this 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.

Conditions

Interventions

DRUG

Cemiplimab

Participants will be given Cemiplimab 350 mg IV day 1 every 21 days

DRUG

Capecitabine

Participants will take Capecitabine at 2 dose levels: 800 mg/m\^2 and 1000 mg/m\^2 by mouth twice daily 14 days on, 7 days off starting on day 3 every 21 days.

Sponsors & Collaborators

Principal Investigators

  • Aixa E Soyano Muller, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2024-09-09
Completion
2025-03-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064085 on ClinicalTrials.gov