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Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 15, 2025 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study Identification, Study Status, Oversightv9
  2. Primary completion date: Sep 1, 2024 to Sep 1, 2026
    • Study completion date: Sep 1, 2025 to Sep 1, 2027
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 10, 2022 to Sep 23, 2022
    v6
  5. Primary completion date: Nov 1, 2023 to Sep 1, 2024
    • Start date: Aug 1, 2022 to Sep 10, 2022
    • Study completion date: Nov 1, 2023 to Sep 1, 2025
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jul 1, 2022 to Aug 1, 2022v4
  2. Start date: Apr 1, 2022 to Jul 1, 2022v3
  3. Start date: Nov 1, 2021 to Apr 1, 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were HER2-negative by standard tests but showed abnormal HER2 activity based on the CELsignia results.
Trial Details
NCT Number NCT04965064
Lead Sponsor University of Rochester
Conditions
(from sponsor)		 Breast Cancer
Related terms Brain Neoplasms, Breast Neoplasms
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov