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Adjuvant Palbociclib in Elderly Patients With Breast Cancer

Study acronym: Appalaches
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 12, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion date: Jun 30, 2026 to Sep 30, 2026
    • Study completion date: Sep 30, 2032 to Sep 30, 2026
    v20
  2. Notable Primary completion date: Sep 30, 2027 to Jun 30, 2026v19
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 13, 2027 to Sep 30, 2027
    • Study completion date: Sep 13, 2032 to Sep 30, 2032
    • Site details revised at 73 of 73 sites
    v18
  4. Notable Primary completion date: Jun 13, 2025 to Sep 13, 2027
    • Study completion date: Jun 13, 2032 to Sep 13, 2032
    • Collaborators: 7 to 8
    v17
  5. Minor Study sites: 71 to 73v16
Show 14 earlier versionsHide 14 earlier versions
  1. Minor Study sites: 68 to 71v15
  2. Minor Study sites: 58 to 68v14
  3. Notable Primary completion date: Jun 13, 2024 to Jun 13, 2025
    • Study sites: 53 to 58
    • Study completion date: Jun 13, 2031 to Jun 13, 2032
    v13
  4. Minor Study sites: 49 to 53v12
  5. Minor Study sites: 40 to 49v11
  6. Minor Study sites: 36 to 40v10
  7. Minor Study sites: 29 to 36v9
  8. Minor Study sites: 24 to 29v8
  9. Minor Study sites: 17 to 24v7
  10. Minor Study sites: 15 to 17
    • Collaborators: 6 to 7
    v6
  11. Minor Study sites: 3 to 15v5
  12. Minor Study sites: 1 to 3v4 Show 4 more changesShow less
    • Primary completion date: May 7, 2024 to Jun 13, 2024
    • Study completion date: May 7, 2031 to Jun 13, 2031
    • Start date changed from estimate of Jun 13, 2019 to Jun 14, 2019
    • Collaborators: 4 to 6
  13. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 7, 2019 to Jun 13, 2019
    • Study sites: 0 to 1
    • Collaborators: 1 to 4
    v3
  14. Notable Start date: Jan 7, 2019 to May 7, 2019
    • Primary completion date: Jan 7, 2024 to May 7, 2024
    • Study completion date: Jan 7, 2031 to May 7, 2031
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.
Trial Details
NCT Number NCT03609047
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Pfizer, Swedish Association of Breast Oncologists, ETOP IBCSG Partners Foundation, German Adjuvant Breast Cancer Group, SOLTI Breast Cancer Research Group, UNICANCER, Gruppo Oncologico Italiano di Ricerca Clinica, Breast International Group
Conditions
(from sponsor)
Breast Cancer Stage II, Breast Cancer Stage III
Related terms Breast Neoplasms
Enrollment 366 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov