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A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 30, 2024 to Dec 31, 2027 Completion date: Dec 30, 2024 to Dec 31, 2027v7 Show 1 more changeShow less
    • Completion date: Dec 30, 2024 to Dec 31, 2027
  2. Primary completion date: Dec 31, 2023 to Jun 30, 2024v6
  3. Primary completion date: Dec 31, 2022 to Dec 31, 2023 Completion date: Dec 30, 2023 to Dec 30, 2024v5 Show 1 more changeShow less
    • Completion date: Dec 30, 2023 to Dec 30, 2024
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Oct 31, 2022 to Dec 31, 2022 · Completion date: Jun 30, 2023 to Dec 30, 2023 · 2 morev3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Oct 31, 2022 to Dec 31, 2022
    • Completion date: Jun 30, 2023 to Dec 30, 2023
    • Start date changed from estimate of Jul 31, 2020 to Sep 29, 2020
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Study title expanded, about 12 wordsv2 See this version in full on ClinicalTrials.gov ↗
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.
Trial Details
NCT Number NCT04400695
Lead Sponsor RemeGen Co., Ltd.
Conditions Breast Cancer
Enrollment 366 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov