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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01783444

Public ClinicalTrials.gov record NCT01783444. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:49 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Three-arm, Randomized, Open Label, Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01783444
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
309 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 26, 2013 (Actual)
Primary completion
Jul 2, 2018 (Actual)
Completion
Jul 30, 2018 (Actual)
Last update posted
Feb 26, 2021

2013 – 2018

United States locations

U.S. sites
19
U.S. states
11
U.S. cities
18
Facility City State ZIP Site status
University of California at Los Angeles Mattel Children's Hospital Los Angeles California 90095 —
Sharp Memorial Hospital SharpClinicalOncologyResearch San Diego California 92123 —
Florida Cancer Specialists Dept of Oncology (2) Fort Myers Florida 33901 —
Florida Cancer Specialists FL Cancer Specialists Fort Myers Florida 33901 —
Lahey Clinic Dept of Lahey Clinic (2) Burlington Massachusetts 01805 —
New England Hematology/ Oncology Associates, P.C. SC Newton Massachusetts 02462 —
Glacier View Research Institute - Cancer SC Kalispell Montana 59901 —
Trinitas Comprehensive Cancer Center SC Elizabeth New Jersey 07207 —
Hackensack University Medical Center Dept of Oncology Hackensack New Jersey 07601 —
Rutgers-New Jersey Medical School SC Newark New Jersey 07101 —
Oncology Hematology Care Inc Oncology Hematology Care 2 Cincinnati Ohio 45242 —
Oklahoma Cancer Specialists and Research Institute Oklahoma Cancer Specialists Tulsa Oklahoma 74136 —
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology Chattanooga Tennessee 37404 —
The Jones Clinic SC Germantown Tennessee 38138 —
University of Tennessee SC Knoxville Tennessee 27920-6969 —
Sarah Cannon Research Institute SC (2) Nashville Tennessee 37203 —
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD Fort Worth Texas 76104 —
University of Virginia Health Systems SC-4 Charlottesville Virginia 22908-0334 —
Northwest Medical Specialties Dept of Onc Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01783444, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2021 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01783444 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →