Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Study completion pushed from Jun 2027 to Dec 2027
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Publications: details revised at 2 of 2 entries
  2. Re-verified, no change to tracked fieldsv36
  3. Study completion date: Jun 2026 to Jun 2027v35
  4. Secondary endpoints: details revised at 3 of 3 entriesv34
  5. Study completion date: Jun 2025 to Jun 2026v33
Show 31 earlier versionsHide 31 earlier versions
  1. Re-verified, no change to tracked fieldsv32
  2. Study completion date: May 2025 to Jun 2025v31
  3. Study completion date: Dec 2024 to May 2025
    • Secondary endpoints: details revised at 3 of 3 entries
    v30
  4. Study completion date: Dec 2023 to Dec 2024v29
  5. Re-verified, no change to tracked fieldsv28
  6. Study completion date: Dec 2022 to Dec 2023v27
  7. Re-verified, no change to tracked fieldsv26
  8. Study completion date: Sep 2022 to Dec 2022v25
  9. Re-verified, no change to tracked fieldsv24
  10. Study completion date: Sep 2021 to Sep 2022v23
  11. Study completion date: Sep 2020 to Sep 2021v22
  12. Study completion date: Sep 2019 to Sep 2020
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 7 words
    v21
  13. Results first posted: Apr 12, 2019v20 Show 7 more changesShow less
    • Primary endpoint revised
    • Trial status: Completed to Active, Not Recruiting
    • Study completion date: Apr 15, 2018 to Sep 2019
    • Start date: Jan 2014 to Jan 30, 2014
    • Secondary endpoints revised (3)
    • Collaborators expanded, about 7 words
    • Publications: details revised at 1 of 2 entries
  14. Primary completion date: Aug 15, 2017 to Mar 20, 2018v19
  15. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Sep 2018 to Apr 15, 2018
    v18
  16. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 13 to 10
    • Primary completion date changed from estimate of Sep 2017 to Aug 15, 2017
    v17
  17. Primary completion date: Jan 2017 to Sep 2017
    • Study completion date: Jul 2018 to Sep 2018
    • Site details revised at 1 of 13 sites
    v16
  18. Re-verified, no change to tracked fieldsv15
  19. Primary completion date: Jan 2016 to Jan 2017
    • Study completion date: Jul 2017 to Jul 2018
    • Eligibility criteria expanded, about 27 words
    • Site details revised at 1 of 13 sites
    v14
  20. Study sites: 11 to 13v13
  21. Study sites: 10 to 11v12
  22. Study sites: 9 to 10v11
  23. Study sites: 8 to 9v10
  24. Study sites: 7 to 8v9
  25. Study sites: 6 to 7v8
  26. Study sites: 2 to 6v7
  27. Re-verified, no change to tracked fieldsv6
  28. Study sites: 1 to 2v5
  29. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Sep 2013 to Jan 2014
    • Primary completion date: Dec 2015 to Jan 2016
    • Study completion date: Dec 2016 to Jul 2017
    • Site details revised
  30. Re-verified, no change to tracked fieldsv3
  31. Study description expanded, about 1 wordv2
  1. Study First Submitted
  • 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 research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
Trial Details
NCT Number NCT01937117
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Translational Breast Cancer Research Consortium, Genentech, Inc.
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov