Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer

NCT01325428 · View on ClinicalTrials.gov ↗

Study Summary

The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.

Conditions Studied

Interventions

  • DRUG Afatinib once daily (OD)
  • DRUG Vinorelbine Weekly

Study Locations (16)

Other

  • 1200.89.85201 Boehringer Ingelheim Investigational Site — Hong Kong
  • 1200.89.82001 Boehringer Ingelheim Investigational Site — Seoul
  • 1200.89.82002 Boehringer Ingelheim Investigational Site — Seoul
  • 1200.89.66002 Boehringer Ingelheim Investigational Site — Bangkok
  • 1200.89.66004 Boehringer Ingelheim Investigational Site — Bangkok
  • 1200.89.66003 Boehringer Ingelheim Investigational Site — Chiang Mai
  • 1200.89.66001 Boehringer Ingelheim Investigational Site — Hat-Yai, Songkhla
  • 1200.89.21601 Boehringer Ingelheim Investigational Site — Aryanah
  • 1200.89.21602 Boehringer Ingelheim Investigational Site — Sousse
  • 1200.89.44002 Boehringer Ingelheim Investigational Site — Bournemouth
  • 1200.89.44001 Boehringer Ingelheim Investigational Site — London
  • 1200.89.44003 Boehringer Ingelheim Investigational Site — London

California

  • 1200.89.10001 Boehringer Ingelheim Investigational Site — Los Angeles

North Carolina

  • 1200.89.10005 Boehringer Ingelheim Investigational Site — Durham

Victoria

  • 1200.89.61002 Boehringer Ingelheim Investigational Site — East Bentleigh

Western Australia

  • 1200.89.61003 Boehringer Ingelheim Investigational Site — Perth

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2011-08
Est. Completion 2014-11
Phase Phase 2

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01325428

The ClinicalTrials.gov registry entry for NCT01325428 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which Afatinib once daily (OD) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01325428 reports 16 study locations spanning 5 distinct geographic areas — top geographies include Other, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01325428 about?

NCT01325428 is a clinical study titled "Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer". The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory bre...

What is the current status of trial NCT01325428?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2011-08. Estimated completion is 2014-11.

What conditions does trial NCT01325428 study?

This clinical trial studies the following conditions: Breast Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01325428?

The interventions under investigation include: Afatinib once daily (OD) (DRUG), Vinorelbine Weekly (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01325428?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01325428 being conducted?

This trial has 16 study locations across California, North Carolina, Victoria, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial