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Anti-metabolites

Capecitabine + Cemiplimab for Breast Cancer

Phase 1
Waitlist Available
Led By Aixa E Soyano Muller, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (EGOG) performance status 0 through 2
Pathologic confirmation of noninvasive breast cancer that is Hormone-receptor positive (HR+) (ER [estrogen-receptor] and/or PR [progesterone-receptor] >/= 1%, locally advanced, or metastatic disease
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of investigational product
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new chemotherapy combination to treat metastatic breast cancer. The goal is to assess safety and efficacy.

Who is the study for?
This study is for adults with hormone-receptor-positive, HER2-negative metastatic breast cancer. Participants must have a performance status of 0-2, indicating they are fully active or capable of self-care. They should not have used PD-1/PD-L1 inhibitors like cemiplimab before and must be free from certain other treatments and conditions that could affect the trial's safety or results.
What is being tested?
The trial tests how safe and effective the combination of capecitabine (oral chemotherapy) and cemiplimab (an immune therapy drug) is in treating metastatic breast cancer. It's an early-phase study where all participants receive both drugs to see if they work better together.
What are the potential side effects?
Possible side effects include typical chemotherapy-related issues such as nausea, fatigue, diarrhea, hand-foot syndrome from capecitabine; and immune-related reactions like skin rash or thyroid problems due to cemiplimab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My breast cancer is noninvasive, hormone-receptor positive, and either locally advanced or metastatic.
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I am willing to stop taking any herbal remedies that affect the immune system before starting cemiplimab.
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My body weight is over 30 kg.
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I have had hormone therapy for cancer that cannot be surgically removed.
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My breast cancer is HER2 negative according to specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that my doctors are still trying to get under control.
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I haven't had major surgery in the last 28 days.
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I have seizures that are not controlled by medication.
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I have previously been treated with a PD-1 or PD-L1 inhibitor.
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My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recommended Phase 2 Dose (RP2D)
Secondary study objectives
Clinical Benefit Rate (CBR)
Objective Response Rate (ORR)
Progression Free Survival (PFS)

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Mucositis
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Bone pain
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Cholecystitis acute
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Level 2Experimental Treatment2 Interventions
Cemiplimab 350mg + Capecitabine 1000 mg/m\^2
Group II: Dose Level 1Experimental Treatment2 Interventions
Cemiplimab 350mg + Capecitabine 800 mg/m\^2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
Capecitabine
2013
Completed Phase 3
~4280

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
564 Previous Clinical Trials
144,870 Total Patients Enrolled
41 Trials studying Breast Cancer
4,096 Patients Enrolled for Breast Cancer
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,830 Total Patients Enrolled
1 Trials studying Breast Cancer
169 Patients Enrolled for Breast Cancer
Aixa E Soyano Muller, MDPrincipal InvestigatorMoffitt Cancer Center
Hung T Khong, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05064085 — Phase 1
Breast Cancer Research Study Groups: Dose Level 1, Dose Level 2
Breast Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT05064085 — Phase 1
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064085 — Phase 1
~3 spots leftby Dec 2025
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