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A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Study acronym: ADEPT
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Mar 23, 2026 → Mar 23, 2029
See other at-risk trials from Dana-Farber Cancer Institute

Record History

  1. Primary completion pushed from Mar 23, 2026 to Mar 23, 2029 Completion pushed from Sep 1, 2030 to Sep 1, 2032 · Eligibility criteria expanded, about 52 words · Secondary endpoints: details revised at 5 of 11 entries · 3 more Show 6 more changesShow less
    • Completion pushed from Sep 1, 2030 to Sep 1, 2032
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 5 of 11 entries
    • Site details revised at 2 of 32 sites
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 375 to confirmed 393 · Primary completion date changed from estimate of Sep 1, 2026 to Mar 23, 2026 · Site details revised at 32 of 32 sitesv31 Show 3 more changesShow less
    • Enrollment target: estimated 375 to confirmed 393
    • Primary completion date changed from estimate of Sep 1, 2026 to Mar 23, 2026
    • Site details revised at 32 of 32 sites
  3. Study sites revised (32)v30 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 30 to 32v29
  5. Study sites revised (30)v28 See this version in full on ClinicalTrials.gov ↗
Show 26 earlier versionsHide 26 earlier versions
  1. Study sites: 28 to 30v27
  2. Eligibility criteria shortened, about 133 wordsv26 See this version in full on ClinicalTrials.gov ↗
  3. Site contacts updated at 1 of 28 sitesv25
  4. Study sites: 26 to 28v24
  5. Study sites: 25 to 26v23
  6. Study sites: 24 to 25v22
  7. Study sites: 23 to 24v21
  8. Study sites: 22 to 23v20
  9. Study sites: 18 to 22v19
  10. Eligibility criteria expanded, about 35 wordsv18 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 17 to 18v17
  12. Study sites: 15 to 17v16
  13. Study sites: 13 to 15v15
  14. Study sites: 12 to 13v14
  15. Study sites: 9 to 12v13
  16. Site contacts updated at 1 of 9 sitesv12
  17. Study sites: 8 to 9v11
  18. Site details revised at 2 of 8 sitesv10
  19. Study sites: 7 to 8v9
  20. Study sites: 6 to 7v8
  21. Study sites: 5 to 6v7
  22. Eligibility criteria expanded, about 34 words Secondary endpoints: 10 to 11v6 Show 1 more changeShow less
    • Secondary endpoints: 10 to 11

    See this version in full on ClinicalTrials.gov ↗

  23. Site details revised at 2 of 5 sitesv5
  24. Study sites: 2 to 5v4
  25. Start date changed from estimate of Jan 2021 to Jan 11, 2021v3
  26. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2021 to Jan 2021 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date: Feb 2021 to Jan 2021
    • Site details revised at 2 of 2 sites
  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.
This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are: * A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO) * Hormonal (endocrine) Treatment
Trial Details
NCT Number NCT04569747
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Genentech, Inc.
Conditions HER2-positive Breast Cancer, Invasive Carcinoma of the Breast, Breast Cancer, Node Negative Breast Cancer, Micrometastasis Breast Cancer, Hormone Receptor Positive Breast Cancer
Enrollment 393 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov