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NCT01441596 · ClinicalTrials.gov registry record · Phase 2

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
121
Enrollment target

NCT01441596 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 121 participants.

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The verdict

NCT01441596, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
121 participants
Enrollment target

Study Summary

The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

Interventions

  • DRUG Vinorelbine
  • DRUG afatinib
  • DRUG Investigator's choice of treatment

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2011-10
Est. Completion 2014-08
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01441596

The ClinicalTrials.gov registry entry for NCT01441596 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 121 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 Vinorelbine is the first listed.

NCT01441596 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01441596 about?

NCT01441596 is a clinical study titled "Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases". The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

What is the current status of trial NCT01441596?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2011-10. Estimated completion is 2014-08.

What interventions are being tested in trial NCT01441596?

The interventions under investigation include: Vinorelbine (DRUG), afatinib (DRUG), Investigator's choice of treatment (DRUG).

Who is sponsoring clinical trial NCT01441596?

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.