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NCT00777101 · ClinicalTrials.gov registry record · Phase 2

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

A Phase 2 study, sponsored by Puma Biotechnology.

Completed
Registry status
Phase 2
Development phase
233
Enrollment target

NCT00777101 is a Phase 2 study that has completed, run by Puma Biotechnology. The registered enrollment target is 233 participants.

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The verdict

NCT00777101, a Phase 2 study, has completed, sponsored by Puma Biotechnology.

COMPLETED
Registry status
Phase 2
Development phase
233 participants
Enrollment target

Study Summary

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Interventions

  • DRUG Capecitabine
  • DRUG Neratinib
  • DRUG Lapatinib

Trial Details

FieldValue
Enrollment Target 233 participants
Start Date 2009-02-04
Est. Completion 2018-06-03
Phase Phase 2

Sponsor

Puma Biotechnology

28 total trials

What the Registry Record Tells You About NCT00777101

The ClinicalTrials.gov registry entry for NCT00777101 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 233 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.

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

NCT00777101 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00777101 about?

NCT00777101 is a clinical study titled "Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer". This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of ...

What is the current status of trial NCT00777101?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 233 participants. The study started on 2009-02-04. Estimated completion is 2018-06-03.

What interventions are being tested in trial NCT00777101?

The interventions under investigation include: Capecitabine (DRUG), Neratinib (DRUG), Lapatinib (DRUG).

Who is sponsoring clinical trial NCT00777101?

This trial is sponsored by Puma Biotechnology, which has 28 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.