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NCT01125566 · ClinicalTrials.gov registry record · Phase 3

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
508
Enrollment target

NCT01125566 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 508 participants.

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The verdict

NCT01125566, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
508 participants
Enrollment target

Study Summary

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Interventions

  • DRUG trastuzumab
  • DRUG vinorelbine
  • DRUG BIBW 2992

Trial Details

FieldValue
Enrollment Target 508 participants
Start Date 2010-06-22
Est. Completion 2018-07-06
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01125566

The ClinicalTrials.gov registry entry for NCT01125566 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 508 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which trastuzumab is the first listed.

NCT01125566 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01125566 about?

NCT01125566 is a clinical study titled "LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment". To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

What is the current status of trial NCT01125566?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2010-06-22. Estimated completion is 2018-07-06.

What interventions are being tested in trial NCT01125566?

The interventions under investigation include: trastuzumab (DRUG), vinorelbine (DRUG), BIBW 2992 (DRUG).

Who is sponsoring clinical trial NCT01125566?

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

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.