ClinicalTrials.gov record
Completed Phase 1 Interventional

Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

ClinicalTrials.gov ID: NCT01857193

Public ClinicalTrials.gov record NCT01857193. 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 May 19, 2026, 6:22 AM 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 Phase Ib Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Study identification

NCT ID
NCT01857193
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
132 participants

Conditions and interventions

Conditions

Interventions

  • Everolimus (RAD001) Drug
  • Exemestane Drug
  • ribociclib (LEE011) Drug

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
Sep 5, 2013
Primary completion
Mar 13, 2018
Completion
Apr 15, 2020
Last update posted
Apr 12, 2021

2013 – 2020

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
Highlands Oncology Group Fayetteville Arkansas 72703
Sylvester Comprehensive Cancer Center Main Center Miami Florida 33136
Massachusetts General Hospital Onc Dept Boston Massachusetts 02114
Karmanos Cancer Institute Dept of Onc Detroit Michigan 48201
Memorial Sloan Kettering Oncology Dept. New York New York 10017
Oregon Health and Science University SC-5 Portland Oregon 97239
University of Texas MD Anderson Cancer Center Onc Dept Houston Texas 77030
Northwest Medical Specialties 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 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01857193, 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 Apr 12, 2021 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01857193 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →