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Sarilumab + Capecitabine for Breast Cancer (EMPOWER Trial)
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.
EMPOWER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMPOWER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 & 3 trial • 151 Patients • NCT03093870EMPOWER Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Experimental: Phase I
- Group 2: Phase 2 single arm study
- Group 3: Parallel Baseline Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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