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Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25

Study acronym: OFSET
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1259 to 1261v41
  2. Trial sites expanded: 1249 → 1259 locationsv40
  3. Trial sites expanded: 1243 → 1249 locationsv39
  4. Trial sites expanded: 1238 → 1243 locationsv38
  5. Trial sites expanded: 1224 → 1238 locations Site details revised at 3 of 1238 sitesv37 Show 1 more changeShow less
    • Site details revised at 3 of 1238 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1224 to 1238v36
  2. Start date: Aug 31, 2023 to Oct 18, 2023v35
  1. Trial sites expanded: 1209 → 1224 locationsv34
  2. Study sites: 1202 to 1209v33
  3. Study sites: 1195 to 1202v32
  4. Study sites: 1185 to 1195v31
  5. Study sites: 1175 to 1185v30
  6. Study sites: 1173 to 1175v29
  7. Study sites: 1145 to 1173v28
  8. Study sites: 1125 to 1145v27
  9. Study sites: 1112 to 1125v26
  10. Study sites: 1095 to 1112v25
  11. Study sites: 1085 to 1095v24
  12. Site details revised at 1 of 1085 sitesv23
  13. Site details revised at 3 of 1085 sitesv22
  14. Study sites: 1068 to 1085v21
  15. Study sites: 1061 to 1068v20
  16. Study sites: 1051 to 1061v19
  17. Study sites: 1034 to 1051v18
  18. Study sites: 1017 to 1034v17
  19. Study sites: 989 to 1017v16
  20. Study sites: 964 to 989v15
  21. Study sites: 867 to 964v14
  22. Study sites: 779 to 867v13
  23. Study sites: 731 to 779v12
  24. Study sites: 649 to 731v11
  25. Study sites: 577 to 649v10
  26. Study sites: 550 to 577v9
  27. Study sites: 420 to 550v8
  28. Study sites: 175 to 420v7
  29. Primary completion date: Feb 2030 to Jan 2032 Study sites: 1 to 175v6 Show 1 more changeShow less
    • Study sites: 1 to 175
  30. Re-verified, no change to tracked fieldsv5
  31. Secondary endpoints: details revised at 1 of 6 entriesv4
  32. Secondary endpoints: details revised at 2 of 6 entries Study description expanded, about 7 words · Eligibility criteria expanded, about 2 wordsv3 Show 2 more changesShow less
    • Study description expanded, about 7 words
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 2023 to Aug 31, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2023 to Aug 31, 2023
  34. 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.
NRG Oncology
67 trials monitored
See 5 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
Trial Details
NCT Number NCT05879926
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Breast Cancer
Enrollment 3,960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov