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Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from Merck (MSD)

Record History

  1. Primary endpoint(s) modified Enrollment increased: 81 → 181 participants · Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC · Trial arms changed: 3 → 4 · 3 more Show 6 more changesShow less
    • Enrollment increased: 81 → 181 participants
    • Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 64 words
    • Secondary endpoints: 9 to 13
    • Site details revised at 2 of 18 sites
  2. Study sites: 17 to 18v21
  3. Study sites: 16 to 17v20
  4. Study sites: 15 to 16v19
  5. Secondary endpoints: details revised at 9 of 9 entriesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Primary and study completion dates: Sep 10, 2029 to Apr 18, 2030 Study sites: 14 to 15v17 Show 1 more changeShow less
    • Study sites: 14 to 15
  2. Study sites: 12 to 14v16
  3. Study sites: 11 to 12v15
  4. Study sites: 10 to 11v14
  5. Study sites: 9 to 10v13
  6. Study sites: 8 to 9v12
  7. Study sites: 6 to 8v11
  8. Site contacts updated at 2 of 6 sitesv10
  9. Re-verified, no change to tracked fieldsv9
  10. Study sites: 5 to 6v8
  11. Study sites: 4 to 5v7
  12. Study sites: 3 to 4v6
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3v5 Show 1 more changeShow less
    • Study sites: 0 to 3
  14. Re-verified, no change to tracked fieldsv4
  15. Primary and study completion dates: Sep 3, 2029 to Sep 10, 2029 Start date: Feb 19, 2025 to Feb 26, 2025 · Eligibility criteria expanded, about 6 wordsv3 Show 2 more changesShow less
    • Start date: Feb 19, 2025 to Feb 26, 2025
    • Eligibility criteria expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  16. Start date: Dec 19, 2024 to Feb 19, 2025 Primary and study completion dates: Jun 26, 2029 to Sep 3, 2029 · Study description expanded, about 18 wordsv2 Show 2 more changesShow less
    • Primary and study completion dates: Jun 26, 2029 to Sep 3, 2029
    • Study description expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  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.
Merck (MSD)
407 trials monitored
See 29 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment
Trial Details
NCT Number NCT06686394
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Breast Neoplasms, Breast Cancer
Enrollment 181 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov