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NCT02278120 · ClinicalTrials.gov registry record · Phase 3

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
672
Enrollment target

NCT02278120 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 672 participants.

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The verdict

NCT02278120, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
672 participants
Enrollment target

Study Summary

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

Interventions

  • DRUG Tamoxifen
  • DRUG Anastrozole
  • DRUG Letrozole
  • DRUG Goserelin
  • DRUG Ribociclib

Trial Details

FieldValue
Enrollment Target 672 participants
Start Date 2014-11-20
Est. Completion 2023-04-20
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT02278120

The ClinicalTrials.gov registry entry for NCT02278120 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 672 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 5 interventions - of which Tamoxifen is the first listed.

NCT02278120 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02278120 about?

NCT02278120 is a clinical study titled "Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer". The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor ...

What is the current status of trial NCT02278120?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 672 participants. The study started on 2014-11-20. Estimated completion is 2023-04-20.

What interventions are being tested in trial NCT02278120?

The interventions under investigation include: Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Goserelin (DRUG), Ribociclib (DRUG).

Who is sponsoring clinical trial NCT02278120?

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.