deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT01669239

Study of Neoadjuvant Myocet®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer (Opti-HER)

OptiHER-Heart: A Prospective, Multicenter, Single-arm, Phase II Study to Evaluate the Safety of Neoadjuvant Liposomal Doxorubicin (Myocet®) Plus Paclitaxel, Trastuzumab, and Pertuzumab in Patients With HER2-positive Breast Cancer

Sponsor: SOLTI Breast Cancer Research Group

Conditions Breast Cancer
Interventions Liposomal Doxorubicin
Updated 7 times since 2017 Last updated: Oct 31, 2017 Started: Jun 30, 2013 Primary completion: Jan 31, 2016 Completion: Jan 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Breast Cancer and is currently completed. SOLTI Breast Cancer Research Group leads this study, which shows 7 recorded versions since 2013 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2018 · 13 months · monthly snapshotCompleted~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 2 earlier versions

  1. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE2

  2. Jan 2017 — Feb 2018 [monthly]

    Completed PHASE2

    First recorded

Jun 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • SOLTI Breast Cancer Research Group
Data source: SOLTI Breast Cancer Research Group

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

Study Locations