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NCT01325428 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Neoplasms, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
26
Enrollment target
16
Study locations

NCT01325428 is a Phase 2 study of Breast Neoplasms that has completed, run by Boehringer Ingelheim. The registered enrollment target is 26 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The trial reports 16 study locations across 5 states.

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The verdict

NCT01325428, a Phase 2 study of Breast Neoplasms, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
26 participants
Enrollment target
16
Study locations

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

Breast Neoplasms

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

515 total trials

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What the Registry Record Tells You About NCT01325428

The ClinicalTrials.gov registry entry for NCT01325428 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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.

NCT01325428 reports 16 study locations spanning 5 distinct geographic areas - top geographies include Other, California, North Carolina.

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.

What interventions are being tested in trial NCT01325428?

The interventions under investigation include: Afatinib once daily (OD) (DRUG), Vinorelbine Weekly (DRUG).

Who is sponsoring clinical trial NCT01325428?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.