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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 18 years old or older.
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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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My cancer can be measured or observed.
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I have had hormone therapy for cancer that cannot be surgically removed.
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My organs and bone marrow are working well.
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My breast cancer is HER2 negative according to specific tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Objective Response Rate (ORR)
Progression Free Survival (PFS)
Side effects data
From 2020 Phase 2 & 3 trial • 151 Patients • NCT0309387063%
Nausea
58%
Fatigue
54%
Diarrhoea
50%
Decreased Appetite
46%
Vomiting
42%
Pyrexia
42%
Hypokalaemia
38%
Abdominal Pain
33%
Constipation
33%
Blood Bilirubin Increased
29%
Abdominal Distension
29%
Hyponatraemia
29%
Dizziness
29%
Oedema Peripheral
29%
Back Pain
25%
Hypotension
25%
Stomatitis
25%
Palmar-plantar Erythrodysaethesia Syndrome
25%
Dehydration
25%
Anaemia
21%
Aspartate Aminotransferase Increased
21%
Dyspnoea
21%
Chills
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Hyperbilirubinaemia
13%
Cough
13%
Abdominal Pain Upper
13%
Blood Creatinine Increased
13%
Hypomagnesaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Depression
8%
Gastrooesophageal Reflux Disease
8%
Gamma-glutamyltransferase increased
8%
International normalised ratio increased
8%
Paraesthesia
8%
Influenza like illness
8%
Dysphonia
8%
Malaise
8%
Hypoaesthesia
8%
Faeces discolored
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Blood alkaline phosphatase increased
8%
Epistaxis
8%
Bile duct obstruction
8%
Oral pain
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Rhinitis allergic
8%
Bursitis
8%
Musculoskeletal pain
8%
Anxiety
8%
Dysgeusia
8%
Acute kidney injury
8%
Cholangitis
4%
Cardiac arrest
4%
Rash generalized
4%
Respiratory Failure
4%
Septic shock
4%
Small intestinal obstruction
4%
Spinal cord compression
4%
Toxic leukoencephalopathy
4%
Peripheral Sensory Neuropathy
4%
Haematemesis
4%
Hypercalcaemia
4%
Hyponatremia
4%
Hypoxic-ischaemic encephalopathy
4%
Ischaemic stroke
4%
Lung Infection
4%
Metabolic acidosis
4%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo and Capecitabine - Part 1
Varlitinib and Capecitabine - Safety Lead-In
Varlitinib and Capecitabine - Part 1
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
~1340
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,479 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
Regeneron PharmaceuticalsIndustry Sponsor
616 Previous Clinical Trials
379,832 Total Patients Enrolled
1 Trials studying Breast Cancer
169 Patients Enrolled for Breast Cancer
Aixa E Soyano Muller, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of a weak immune system since birth.I have not received a live vaccine in the last 30 days.I do not have any severe illnesses that my doctors are still trying to get under control.I can take care of myself and am up and about more than half of my waking hours.I haven't had major surgery in the last 28 days.I have seizures that are not controlled by medication.My breast cancer is noninvasive, hormone-receptor positive, and either locally advanced or metastatic.I have or had an autoimmune or inflammatory disorder but meet the exceptions listed.I am 18 years old or older.I haven't taken strong immune system suppressing drugs in the last 14 days, except for minor exceptions like creams or inhalers.I do not have active infections like TB, hepatitis B or C, or HIV.I haven't taken immune-modulating drugs in the last 4 weeks or stopped due to side effects.I am willing to stop taking any herbal remedies that affect the immune system before starting cemiplimab.I had chemotherapy for cancer that couldn't be surgically removed, but stopped early for reasons other than the cancer getting worse.My body weight is over 30 kg.I have previously been treated with a PD-1 or PD-L1 inhibitor.You have had an organ transplant from someone else.You are allergic to cemiplimab or any of its ingredients.I had cancer before, but it was treated successfully and has been inactive for over 2 years.I have been treated with idelalisib before.My cancer can be measured or observed.I have brain metastasis but haven't been on steroids for 2 months.My cancer has spread to the lining of my brain and spinal cord.I have had hormone therapy for cancer that cannot be surgically removed.My organs and bone marrow are working well.My breast cancer is HER2 negative according to specific tests.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1
- Group 2: Dose Level 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved Capecitabine for public use?
"Based on our research, Capecitabine acquired a score of 1 due to its Phase 1 trial status. This suggests that there is only limited evidence confirming the drug's safety and efficacy."
Answered by AI
In what medical applications is Capecitabine commonly used?
"Capecitabine is often prescribed for patients with advance directives and it has also demonstrated efficacy in treating malignant neoplasms, metastatic colorectal carcinoma, and pancreatic endocrine carcinoma."
Answered by AI
Are there any recorded precedents of Capecitabine being utilized in research?
"According to the most current records, there are 389 ongoing clinical trials assessing capecitabine with 130 of those investigations in Phase 3. Primarily concentrated within Westmead, New South Wales, a total of 14565 sites throughout the world have initiated studies regarding this drug's effectiveness."
Answered by AI
Can people participate in this research at present?
"That is accurate. According to clinicaltrials.gov, this medical experiment has been open for recruitment since December 10th 2021 and requires 12 participants from one research centre. The trial was last updated on July 27th 2022."
Answered by AI
What is the aggregate amount of participants in this research project?
"Affirmative. Clinicaltrials.gov has documented that this research is presently recruiting participants, having initially been posted on December 10th 2021 and last updated on July 27th 2022. The team needs to find 12 individuals from a solitary site for the trial."
Answered by AI
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