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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
Must not have
Females who are pregnant or breastfeeding
Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 14 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Select...
I am willing to use birth control during and for 24 weeks after the study.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 2021 Phase 3 trial • 693 Patients • NCT0202850763%
Neutrophil count decreased
55%
Fatigue
34%
Hypertension
27%
Mucositis
24%
Nausea
22%
Weight gain
20%
Diarrhea
20%
Arthralgia
19%
Upper respiratory infection
19%
Hypothermia
19%
Weight loss
18%
Vomiting
17%
Headache
15%
Constipation
15%
Back pain
15%
Pruritus
15%
Anorexia
14%
Cough
12%
Dyspepsia
12%
Bone pain
11%
Abdominal pain
11%
Fever
10%
Hot flashes
10%
Flu like symptoms
10%
Alopecia
10%
Pain
8%
Pain in extremity
8%
Obesity
8%
Dizziness
6%
Anemia
6%
Dysgeusia
5%
Nail disorder
5%
Palmar-plantar erythrodysesthesia syndrome
2%
Respiratory infection
1%
Non-cardiac chest pain
1%
Hip replacement
1%
Bacteremia
1%
Urinary bladder carcinoma
1%
Dyspnea
1%
Catheter related infection
1%
Heart failure
1%
Respiratory failure
1%
Stroke
1%
Uveitis
1%
Tooth infection
1%
Hematoma
1%
Acidosis
1%
Febrile neutropenia
1%
Sepsis
1%
Suicide attempt
1%
Urinary tract infection
1%
Lymphedema
1%
Bone fracture
1%
Pneumonitis
1%
Hypercalcemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Palbociclib Plus Exemestane
Cohort 1 and 2: Capecitabine
Cohort 2: Palbociclib Plus Fulvestrant
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~4280
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,158 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,515 Total Patients Enrolled
2 Trials studying Breast
915 Patients Enrolled for Breast
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,554 Total Patients Enrolled
Karen Daily, DOPrincipal InvestigatorUniversity of Florida
David Tran, MD, PhDStudy DirectorUniversity of Florida
2 Previous Clinical Trials
41 Total Patients Enrolled
Priya Jayachandran, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
130 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.