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NCT01007942 · ClinicalTrials.gov registry record · Phase 3

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
569
Enrollment target

NCT01007942 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 569 participants.

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The verdict

NCT01007942, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
569 participants
Enrollment target

Study Summary

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

Interventions

  • DRUG Placebo
  • DRUG trastuzumab
  • DRUG vinorelbine
  • DRUG everolimus

Trial Details

FieldValue
Enrollment Target 569 participants
Start Date 2009-10
Est. Completion 2015-06
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01007942

The ClinicalTrials.gov registry entry for NCT01007942 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 569 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01007942 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01007942 about?

NCT01007942 is a clinical study titled "Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer". This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanc...

What is the current status of trial NCT01007942?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 569 participants. The study started on 2009-10. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01007942?

The interventions under investigation include: Placebo (DRUG), trastuzumab (DRUG), vinorelbine (DRUG), everolimus (DRUG).

Who is sponsoring clinical trial NCT01007942?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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

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.