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A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Study acronym: SERENA-4
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Aug 24, 2026 to Jun 26, 2026 Enrollment target: 1370 to 1371 · Eligibility criteria expanded, about 28 words · Secondary endpoints: details revised at 2 of 11 entries · 2 more Show 5 more changesShow less
    • Enrollment target: 1370 to 1371
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Study description expanded, about 6 words
    • Site details revised at 10 of 263 sites
  2. 2 versions Re-verified since Jul 7, 2025, no change to tracked fieldsv37-v38
  3. Site details revised at 1 of 263 sitesv36
  4. Site details revised at 1 of 263 sitesv35
  5. Re-verified, no change to tracked fieldsv34
Show 32 earlier versionsHide 32 earlier versions
  1. Study sites: 264 to 263v33
  2. Study sites: 287 to 264v32
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 1342 to confirmed 1370 · Study sites: 330 to 287v31 Show 2 more changesShow less
    • Enrollment target: estimated 1342 to confirmed 1370
    • Study sites: 330 to 287
  4. Site details revised at 5 of 330 sitesv30
  5. Study sites: 331 to 330v29
  6. Site details revised at 4 of 331 sitesv28
  7. Study sites: 330 to 331v27
  8. Study sites: 324 to 330v26
  9. Study sites: 321 to 324v25
  10. Site details revised at 3 of 321 sitesv24
  11. Primary completion date: Aug 31, 2026 to Aug 24, 2026 Completion date: Feb 12, 2029 to Feb 1, 2029 · Site details revised at 10 of 321 sitesv23 Show 2 more changesShow less
    • Completion date: Feb 12, 2029 to Feb 1, 2029
    • Site details revised at 10 of 321 sites
  12. Study sites: 320 to 321v22
  13. Study sites: 316 to 320v21
  14. Study sites: 309 to 316 Eligibility criteria revised · Study description expanded, about 66 words · Study title shortened, about 2 wordsv20 Show 3 more changesShow less
    • Eligibility criteria revised
    • Study description expanded, about 66 words
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  15. Primary completion date: Nov 10, 2025 to Aug 31, 2026 Enrollment target: 1402 to 1342 · Study sites: 296 to 309 · Eligibility criteria expanded, about 217 words · 2 morev19 Show 5 more changesShow less
    • Enrollment target: 1402 to 1342
    • Study sites: 296 to 309
    • Eligibility criteria expanded, about 217 words
    • Study description expanded, about 327 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 294 to 296v18
  17. Study sites: 291 to 294v17
  18. Enrollment target: 1342 to 1402 Study sites: 285 to 291v16 Show 1 more changeShow less
    • Study sites: 285 to 291
  19. Study sites: 286 to 285v15
  20. Study sites: 272 to 286v14
  21. Study sites: 269 to 272v13
  22. Site details revised at 176 of 269 sitesv12
  23. Study sites: 268 to 269v11
  24. Study sites: 253 to 268v10
  25. Study sites: 245 to 253v9
  26. Study sites: 210 to 245v8
  27. Study sites: 180 to 210v7
  28. Study sites: 162 to 180v6
  29. Study sites: 141 to 162v5
  30. Study sites: 90 to 141 Completion date: Jan 30, 2029 to Feb 12, 2029 · Secondary endpoints revised (11) · Eligibility criteria expanded, about 3 wordsv4 Show 3 more changesShow less
    • Completion date: Jan 30, 2029 to Feb 12, 2029
    • Secondary endpoints revised (11)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  31. Study sites: 55 to 90 Primary completion date: Oct 29, 2025 to Nov 10, 2025v3 Show 1 more changeShow less
    • Primary completion date: Oct 29, 2025 to Nov 10, 2025
  32. Trial status: Not Yet Recruiting to Recruiting Study sites: 18 to 55v2 Show 1 more changeShow less
    • Study sites: 18 to 55
  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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
Trial Details
NCT Number NCT04711252
Lead Sponsor AstraZeneca
Conditions ER-Positive HER2-Negative Breast Cancer
Enrollment 1,371 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov