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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)

Study acronym: EMPOWER
StatusRecruiting
PhasePhase 1/2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 1, 2026 to Nov 3, 2026
    • Study completion date: Sep 1, 2027 to May 3, 2027
    • Site contacts updated at 2 of 3 sites
    v17
  2. Primary completion date: Nov 3, 2025 to Sep 1, 2026
    • Study completion date: Nov 3, 2026 to Sep 1, 2027
    v16
  3. Start date: Nov 3, 2023 to Sep 26, 2020v15
  4. Lead sponsor: University of Florida to University of Southern Californiav14 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Start date: Sep 26, 2020 to Nov 3, 2023
    • Study sites: 2 to 3
    • Primary completion date: Sep 26, 2025 to Nov 3, 2025
    • Study completion date: Sep 26, 2029 to Nov 3, 2026
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary endpoints revised (3)
    • Eligibility criteria shortened, about 15 words
    • Study description shortened, about 13 words
    v12
  2. 2 versions Re-verified since Nov 15, 2021, no change to tracked fieldsv10-v11
  3. Study sites: 1 to 2
    • Collaborator revised
    v9
  4. Enrollment target: 50 to 65v8
  5. Start date: Aug 25, 2020 to Sep 26, 2020
    • Primary completion date: Jul 31, 2025 to Sep 26, 2025
    • Study completion date: Jul 31, 2029 to Sep 26, 2029
    v7
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2020 to Aug 25, 2020
    • Site details revised
    v6
  7. Start date: Jul 31, 2020 to Aug 2020v5
  8. Study title expanded, about 29 wordsv4
  9. Primary completion date: Jun 2022 to Jul 31, 2025
    • Start date: Jun 2020 to Jul 31, 2020
    • Study completion date: Jun 2022 to Jul 31, 2029
    v3
  10. Study title shortened, about 2 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04333706
Lead Sponsor University of Southern California
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Breast, Metastatic, Triple Negative, Cancer, Disseminated Tumor Cell
Related terms Neoplasm Metastasis, Neoplasms
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov