A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Study acronym: HER2CLIMB-05
StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

The 50 most recent of 112 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Results posted: Sep 29, 2026
    • Site details revised at 38 of 307 sites
  2. Study sites revised (307)v111
  3. Trial sites expanded: 303 → 307 locationsv110
  4. Study sites: 304 to 303v109
  5. Study sites: 303 to 304v108
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 295 to 303v107
  2. Study sites: 299 to 295v106
  3. Primary completion date changed from estimate of Feb 28, 2026 to Sep 5, 2025v105
  4. Study sites: 311 to 299v104
  5. Study sites: 325 to 311v103
  6. Study sites: 365 to 325v102
  7. Primary completion date: May 31, 2025 to Feb 28, 2026
    • Enrollment target: 650 to 654
    • Study sites: 401 to 365
    v101
  8. Enrollment target: 654 to 650v100
  9. Study sites: 290 to 401
    • Study completion date: Oct 31, 2027 to Sep 28, 2027
    v99
  10. Lead sponsor: Seagen Inc. to Seagen, a wholly owned subsidiary of Pfizerv98
  11. 3 versions Re-verified since Oct 14, 2024, no change to tracked fieldsv95-v97
  12. Study sites revised (290)v94
  13. Re-verified, no change to tracked fieldsv93
  14. Study sites: 291 to 290v92
  15. Primary completion date: Oct 31, 2024 to May 31, 2025
    • Study completion date: Jun 30, 2027 to Oct 31, 2027
    • Site details revised at 1 of 291 sites
    v91
  16. Study sites revised (291)v90
  17. 3 versions Re-verified since Aug 4, 2024, no change to tracked fieldsv87-v89
  18. Study sites revised (291)v86
  19. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 650 to confirmed 654
    • Site details revised at 291 of 291 sites
    v85
  20. Site details revised at 2 of 291 sitesv84
  21. Re-verified, no change to tracked fieldsv83
  22. Site details revised at 1 of 291 sitesv82
  23. Re-verified, no change to tracked fieldsv81
  24. Site details revised at 9 of 291 sitesv80
  25. Study sites: 290 to 291v79
  26. Study sites revised (290)v78
  27. Study sites: 289 to 290v77
  28. Site details revised at 1 of 289 sitesv76
  29. Study sites revised (289)v75
  30. Study sites: 288 to 289v74
  31. Study sites: 285 to 288v73
  32. Study sites: 282 to 285v72
  33. Study sites: 280 to 282v71
  34. Study sites: 278 to 280v70
  35. Study sites: 277 to 278v69
  36. Study sites: 275 to 277v68
  37. Study sites: 271 to 275v67
  38. Study sites: 267 to 271v66
  39. Site details revised at 2 of 267 sitesv65
  40. Study sites: 265 to 267v64
  41. Study sites: 262 to 265v63
  • 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.
Pfizer
438 trials monitored
See 32 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
HER2-Positive Cancer
327 trials monitored
See 22 trials at risk
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
Trial Details
NCT Number NCT05132582
Lead Sponsor Seagen, a wholly owned subsidiary of Pfizer
Conditions
(from sponsor)		 HER2 Positive Breast Cancer
Related terms Breast Neoplasms
Enrollment 654 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov