Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05064085
Phase
PHASE1
Status
Completed

Conditions

  • Hormone Receptor-positive Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Participants will be given Cemiplimab 350 mg IV day 1 every 21 days
  • Capecitabine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 12, 2021
Status verified
Mar 2026
Primary completion
Sep 9, 2024
Completion
Mar 13, 2025

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    Cemiplimab 350mg + Capecitabine 800 mg/m\^2
  • Experimental: Dose Level 2
    Cemiplimab 350mg + Capecitabine 1000 mg/m\^2

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

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By research site
Moffitt Cancer Center· Tampa, FL

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