deltatrials
Terminated PHASE2 INTERVENTIONAL NCT01531764

BIBW 2992 (Afatinib) and Vinorelbine

Single-arm, Open-label, Multicentre Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) in Combination With Vinorelbine for the Treatment of Patients With Metastatic Breast Cancer With Intermediate HER2 Expression (HER2 2+ by Immunohistochemistry, Fluorescence In-situ Hybridisation (FISH) Negative) After Failure of First-line Therapy in the Metastatic Setting and Having Been Pre-treated With Anthracyclines

Sponsor: Boehringer Ingelheim

Updated 5 times since 2017 Last updated: Oct 17, 2013 Started: Jul 31, 2012 Primary completion: Sep 30, 2013 Completion: Sep 30, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The recruitment was discontinued because of failure to meet expected enrolment goals

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This PHASE2 trial investigates Carcinoma Breast Stage IV and is currently terminated or withdrawn. Boehringer Ingelheim leads this study, which shows 5 recorded versions since 2012 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  5. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE2

    First recorded

Jul 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boehringer Ingelheim
  • University of Magdeburg
Data source: University of Magdeburg

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