deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT01373710

Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis (HIT)

Phase 1-2 Study of Safety and Efficacy of Intrathecal Trastuzumab Administration in Metastatic HER2 Positive Breast Cancer Patients Developing Carcinomatous Meningitis

Sponsor: Centre Francois Baclesse

Interventions Trastuzumab
Updated 9 times since 2017 Last updated: Nov 19, 2025 Started: May 19, 2011 Primary completion: Apr 30, 2018 Completion: Apr 9, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Carcinomatous Meningitis and Metastatic Breast Cancer, this trial is completed. The trial is conducted by Centre Francois Baclesse and has accumulated 9 data snapshots since 2011. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Sep 2017 · 8 months · monthly snapshotRecruiting~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotActive Not Recruiting~Mar 2019 – ~Aug 2019 · 5 months · monthly snapshotActive Not Recruiting~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Dec 2025 · 15 months · monthly snapshotCompleted~Dec 2025 – present · 5 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Dec 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2024 — Dec 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Aug 2019 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

Show 4 earlier versions
  1. Mar 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Jun 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Sep 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

  4. Jan 2017 — Sep 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

May 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Centre Francois Baclesse
  • Centre Leon Berard
  • Centre Oscar Lambret
  • Groupe Hospitalier Pitie-Salpetriere
  • Hoffmann-La Roche
  • Institut Bergonié
  • Institut Curie
  • Institut du Cancer de Montpellier - Val d'Aurelle
  • University Hospital, Grenoble
  • University Hospital, Toulouse
Data source: Institut Curie

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