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NCT01783444 · ClinicalTrials.gov registry record · Phase 2

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

A Phase 2 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
309
Enrollment target
20
Study locations

NCT01783444: Completed Phase 2 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.

NCT01783444 is a Phase 2 study of Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 309 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01783444, a Phase 2 study of Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
309 participants
Enrollment target
20
Study locations

Study Summary

This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.

Primary Outcome

Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Capecitabine
  • DRUG Exemestane
  • DRUG Everolimus

Study Locations (20)

Tennessee

  • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology - Chattanooga
  • The Jones Clinic SC - Germantown
  • University of Tennessee SC - Knoxville
  • Sarah Cannon Research Institute SC (2) - Nashville

New Jersey

  • Trinitas Comprehensive Cancer Center SC - Elizabeth
  • Hackensack University Medical Center Dept of Oncology - Hackensack
  • Rutgers-New Jersey Medical School SC - Newark

California

  • University of California at Los Angeles Mattel Children's Hospital - Los Angeles
  • Sharp Memorial Hospital SharpClinicalOncologyResearch - San Diego

Florida

  • Florida Cancer Specialists Dept of Oncology (2) - Fort Myers
  • Florida Cancer Specialists FL Cancer Specialists - Fort Myers

Massachusetts

  • Lahey Clinic Dept of Lahey Clinic (2) - Burlington
  • New England Hematology/ Oncology Associates, P.C. SC - Newton

Montana

  • Glacier View Research Institute - Cancer SC - Kalispell

Ohio

  • Oncology Hematology Care Inc Oncology Hematology Care 2 - Cincinnati

Oklahoma

  • Oklahoma Cancer Specialists and Research Institute Oklahoma Cancer Specialists - Tulsa

Trial Details

FieldValue
Enrollment Target 309 participants
Start Date 2013-02-26
Est. Completion 2018-07-30
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01783444 record still lists

NCT01783444 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.

NCT01783444 names 20 study sites across 12 states, led by Tennessee, New Jersey, California.

Frequently Asked Questions

What is clinical trial NCT01783444 about?

NCT01783444 is a clinical study titled "A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.". This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor posi...

What is the current status of trial NCT01783444?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 309 participants. The study started on 2013-02-26. Estimated completion is 2018-07-30.

What conditions does trial NCT01783444 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT01783444?

The interventions under investigation include: Capecitabine (DRUG), Exemestane (DRUG), Everolimus (DRUG).

Who is sponsoring clinical trial NCT01783444?

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

Where is trial NCT01783444 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, Montana, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01783444's enrollment target sits among peer trials

309 271st of 1224 higher than 954 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01783444, the US trial registry maintained by the National Library of Medicine. NCT01783444 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.