Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 9 months later across 2 updates Jul 6, 2026 → May 3, 2027
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Record History

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  1. Primary completion pushed from Nov 11, 2026 to May 3, 2027 Show 6 more changesShow less
    • Study completion date: Dec 30, 2029 to Dec 31, 2029
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 6 of 14 entries
    • Study description revised
    • Site details revised at 3 of 283 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion pushed from Jul 6, 2026 to Nov 11, 2026v32
  3. Site details revised at 3 of 283 sitesv31
  4. Site details revised at 1 of 283 sitesv30
  5. 2 versions Re-verified since Jul 31, 2025, no change to tracked fieldsv28-v29
Show 26 earlier versionsHide 26 earlier versions
  1. Primary completion date: Jul 24, 2025 to Jul 6, 2026
    • Study sites: 284 to 283
    v27
  2. Study sites: 285 to 284v26
  3. Enrollment target: 1156 to 1157
    • Primary completion date: Mar 28, 2025 to Jul 24, 2025
    • Site details revised at 1 of 285 sites
    v25
  4. Enrollment target: 1157 to 1156
    • Site details revised at 8 of 285 sites
    v24
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1134 to confirmed 1157
    • Study sites: 357 to 285
    v23
  6. Re-verified, no change to tracked fieldsv22
  7. Study sites: 356 to 357v21
  8. Study sites: 353 to 356
    • Primary completion date: Dec 30, 2024 to Mar 28, 2025
    v20
  9. Study sites: 349 to 353v19
  10. Study sites: 345 to 349v18
  11. Study sites: 342 to 345v17
  12. Study sites: 340 to 342v16
  13. Study sites: 339 to 340v15
  14. Study sites: 331 to 339v14
  15. Study sites: 329 to 331v13 Show 4 more changesShow less
    • Primary completion date: Jul 24, 2025 to Dec 30, 2024
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 11 to 14
    • Study description revised
  16. Study sites: 321 to 329v12
  17. Study sites: 302 to 321v11
  18. Study sites: 297 to 302v10
  19. Study sites: 282 to 297v9
  20. Study sites: 272 to 282v8
  21. Study sites: 237 to 272v7
  22. Study sites: 221 to 237v6
  23. Study sites: 212 to 221v5
  24. Study sites: 177 to 212v4
  25. Study sites: 125 to 177v3
  26. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 11 to 125
    • Primary completion date: Jul 30, 2025 to Jul 24, 2025
    • Start date changed from estimate of Apr 30, 2021 to Apr 26, 2021
    v2
  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.
AstraZeneca
734 trials monitored
See 61 trials at risk
Breast Cancer
5,481 trials monitored
See 311 trials at risk
HER2-Positive Cancer
328 trials monitored
See 22 trials at risk
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.
Trial Details
NCT Number NCT04784715
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions
(from sponsor)		 Breast Cancer; HER2-positive; Metastatic
Related terms Breast Diseases, Breast Neoplasms, Neoplasm Metastasis
Enrollment 1,157 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov