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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 below

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My breast cancer is triple negative or hormone resistant and Her2 negative.

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I can take care of myself but might not be able to do heavy physical work.

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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:

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I am not pregnant or breastfeeding.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 14 weeks for reporting.

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 • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Mucositis

17%

Headache

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Flu like symptoms

10%

Obesity

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Dysgeusia

Pain

Nail disorder

Respiratory infection

Abdominal pain

Spinal cord compression

Heart failure

Bronchial infection

Pleural effusion

Ascites

Osteonecrosis of jaw

Urinary tract infection

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Thromboembolic event

Dislocation of hip

Palmar-plantar erythrodysesthesia syndrome

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

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

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

~3960

0 / 5Eligibility criteria met