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Terminated PHASE2 INTERVENTIONAL 2-arm NCT04578106

Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy (ELPIS)

Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy

Sponsor: Fundacio Clinic Barcelona

Updated 8 times since 2020 Last updated: Jan 2, 2026 Started: Sep 23, 2020 Primary completion: Jul 16, 2024 Completion: Jul 16, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was prematurely halted primarily due to low patient accrual. Despite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible

A PHASE2 clinical study on HER2-positive Breast Cancer and Stage I Breast Cancer, this trial is terminated or withdrawn. The trial is conducted by Fundacio Clinic Barcelona and has accumulated 8 data snapshots since 2020. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~May 2021 · 4 months · monthly snapshotRecruiting~May 2021 – ~Feb 2022 · 9 months · monthly snapshotRecruiting~Feb 2022 – ~Jun 2024 · 28 months · monthly snapshotRecruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Feb 2026 · 17 months · monthly snapshotRecruiting~Feb 2026 – present · 5 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Feb 2026 — Present [monthly]

    Terminated PHASE2

    Status: RecruitingTerminated

  2. Sep 2024 — Feb 2026 [monthly]

    Recruiting PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  4. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

  5. Feb 2022 — Jun 2024 [monthly]

    Recruiting PHASE2

Show 3 earlier versions
  1. May 2021 — Feb 2022 [monthly]

    Recruiting PHASE2

  2. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE2

  3. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

    First recorded

Sep 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fundacio Clinic Barcelona
  • Roche Pharma AG
  • SOLTI Breast Cancer Research Group
Data source: Fundacio Clinic Barcelona

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations