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Chemotherapy
Sarilumab + Capecitabine for Breast Cancer (EMPOWER Trial)
Phase 1 & 2
Recruiting
Led By Karen Daily, DO
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A clinical diagnosis of metastatic triple negative or hormone resistant, Her2/neu-negative breast cancer that has been confirmed histologically at one point during the course of the disease
An ECOG Performance Status ≤2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 14 weeks
Awards & highlights
EMPOWER Trial Summary
This trial is testing an innovative way to try to eliminate all residual disease in patients with an aggressive form of breast cancer, even after standard treatment.
Who is the study for?
This trial is for adults with metastatic triple negative or hormone resistant, Her2/neu-negative breast cancer. They must have a life expectancy of at least 6 months, not be pregnant or breastfeeding, and agree to use effective contraception. No prior treatment with capecitabine or sarilumab is allowed except in neoadjuvant regimens.Check my eligibility
What is being tested?
The study tests Sarilumab combined with Capecitabine on patients who still have minimal residual disease after standard treatments for aggressive triple negative breast cancer. The goal is to improve survival by eliminating this remaining disease.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, gastrointestinal issues due to Capecitabine, and possible injection site reactions from Sarilumab. Specific side effect profiles will depend on the individual's response to these medications.
EMPOWER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is triple negative or hormone resistant and Her2 negative.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My breast cancer is triple-negative, not responding to hormones or HER2.
EMPOWER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Dose-limiting toxicity (DLT)
Phase I: Maximum Tolerated Dose (MTD)
Phase II:To determine the percent of patients with positive CTCs and DTCs (if available) becoming negative CTCs and DTCs (if available) after treatment
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
EMPOWER Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2 single arm studyExperimental Treatment2 Interventions
Study of adjuvant sarilumab plus capecitabine in stage I to III TNBC with less than a pCR
Group II: Parallel Baseline ArmExperimental Treatment1 Intervention
Study of standard adjuvant capecitabine in stage I to III TNBC with less than a pCR. This Arm will be open in parallel with both Phases 1 and 2. Blood samples will be obtained during the course of the study. Bone marrow samples are optional.
Group III: Experimental: Phase IExperimental Treatment2 Interventions
A dose finding study of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,602 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,789 Total Patients Enrolled
2 Trials studying Breast
915 Patients Enrolled for Breast
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,223 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is triple negative or hormone resistant and Her2 negative.I don't have any health conditions that would make the study treatment unsafe for me.I have a history of diverticulitis.I haven't had systemic treatment for breast cancer, except as part of a neoadjuvant regimen that didn't include capecitabine or sarilumab.I can take care of myself but might not be able to do heavy physical work.My breast cancer is triple-negative, not responding to hormones or HER2.I have had a tuberculosis injection in the past.My doctor thinks my other cancer is more likely to come back or be fatal than the cancer in this study.I am not pregnant or breastfeeding.I have not received any live vaccines in the last 30 days.I haven't had chemotherapy in the last 3 weeks and have received hormone therapy for my cancer.You are expected to live for at least 6 months.You are required to stay in a hospital for treatment of a mental or physical illness.I am 18 years old or older.I am willing to use birth control during and for 24 weeks after the study.I do not have hepatitis B, except from vaccination.My organs are working well.I agree to use approved birth control during and for 24 weeks after the study.My breast cancer is stage I, II, or III and not fully removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Phase I
- Group 2: Phase 2 single arm study
- Group 3: Parallel Baseline Arm
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.
What maladies is Capecitabine regularly prescribed for?
"Capecitabine is the go-to treatment for metastatic colorectal carcinoma, but it has also been known to help with other conditions such as malignant neoplasms, pancreatic endocrine carcinoma and rheumatoid arthritis."
Answered by AI
Is the age qualification for this study restricted to those under 45?
"This study necessitates that its participants are between the ages of 18 and 99. There are 73 clinical trials available for minors, while 1119 exist to serve people over 65 years old."
Answered by AI
Could you elaborate on previous research related to Capecitabine?
"According to the current data, 340 medical studies are being conducted regarding Capecitabine. Of these active trials, 128 belong to Phase 3 and can be found in Woolloongabba, Queensland along with other 13291 sites."
Answered by AI
Is there an opportunity to join this experiment?
"Eligible participants must have cancer and be between 18 years old and 99. The clinical trial is planning to accept up to 65 volunteers."
Answered by AI
What is the current capacity of participants in this study?
"Affirmative. According to clinicaltrials.gov, the trial is presently searching for volunteers and was first announced on September 26th 2020. The project requires 65 participants from two research sites to be enrolled by July 21st 2022."
Answered by AI
Are there any open slots for patients to join this clinical experiment?
"Clinicaltrials.gov provides evidence that this clinical trial is actively accepting participants to participate in the study, which was first posted on September 26th 2020 and last modified on July 21st 2022."
Answered by AI
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