A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04333706
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Breast
  • Cancer
  • Disseminated Tumor Cell
  • Metastatic
  • Triple Negative

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Capecitabine 1000 mg BID
  • Sarilumab 150mg or 200 mg plus Capecitabine — COMBINATION_PRODUCT
    Sarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID
  • Sarilumab 150mg plus Capecitabine — COMBINATION_PRODUCT
    Dose escalation schedule of sarilumab. The starting dose for sarilumab is 150 mg SQ every 21 days, given 3 days prior to the first 4 of 8 cycles of capecitabine 1000 mg BID.

Study Details

This study looks to advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy. The high risk occurs despite surgical excision of the primary tumor and axillary lymph nodes to eliminate residual disease.

Key Dates

Start date
Sep 26, 2020
Status verified
Mar 2026
Primary completion
Nov 3, 2026
Completion
May 3, 2027

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Phase I
    A dose finding study of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer.
  • Experimental: Phase 2 single arm study
    Study of adjuvant sarilumab plus capecitabine in stage I to III TNBC with less than a pCR
  • Other: Parallel Baseline Arm
    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.

Primary Outcome Measure

Phase I: Maximum Tolerated Dose (MTD) [ Time Frame: first treatment up to 9 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033
Kimberly Arieli, RN
[email protected]
323-865-3935
Anastasia Martynova, MD (PRINCIPAL_INVESTIGATOR)
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Kimberly Arieli, RN
[email protected]
323-865-3935
Anastasia Martynova, MD (PRINCIPAL_INVESTIGATOR)
UF HealthGainesvilleFlorida32610-

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By research site
Los Angeles General Medical Center· Los Angeles, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAUF Health· Gainesville, FL

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