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Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole (BOLERO-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00863655
First received: March 16, 2009
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

Condition Intervention Phase
Breast Cancer
Drug: Everolimus
Drug: Exemestane
Drug: Everolimus Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments. [ Time Frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months ]
    Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.


Secondary Outcome Measures:
  • Overall Survival (OS) by Number of Deaths [ Time Frame: up to 53 months ]
    Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.

  • Overall Survival (OS) by Median [ Time Frame: up to 53 months ]
    Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause.

  • Overall Response Rate (ORR) [ Time Frame: up to 21 months ]
    Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

  • Clinical Benefit Rate (CBR) [ Time Frame: up to 21 months ]
    CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) >= 24 weeks, according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.

  • Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier [ Time Frame: 2, 4, 6, 9 months ]
    The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, & physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature. 2: Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement.

  • Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30 [ Time Frame: Up to 21 months ]
    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

  • Proportion of Patients With Having no Overall Response Based on Investigator Assessment [ Time Frame: 2, 4, 6, 9 months ]
    overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

  • Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier [ Time Frame: 21 months ]
    Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

  • Everolimus Concentrations at Week 4 [ Time Frame: pre-dose, 2 hours post-dose ]
    Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.

  • Exemestane Concentrations at Week 4 [ Time Frame: predose, 2 hours post-dose ]
    Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.

  • Estradiol Plasma Concentrations [ Time Frame: Baseline, Week 4 ]
    Compare estradiol concentrations from baseline to week 4 in both treatment arms.


Enrollment: 724
Actual Study Start Date: June 3, 2009
Study Completion Date: December 4, 2014
Primary Completion Date: December 4, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus + Exemestane
Everolimus 10 mg daily in combination with exemestane 25 mg daily
Drug: Everolimus
Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
Other Name: RAD001
Drug: Exemestane
Exemestane 25 mg orally daily.
Active Comparator: Placebo + Exemestane
Placebo of everolimus in combination with exemestane 25 mg daily
Drug: Exemestane
Exemestane 25 mg orally daily.
Drug: Everolimus Placebo
Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
  • Postmenopausal women.
  • Disease refractory to non steroidal aromatase inhibitors (NSAI),
  • Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
  • Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.

Exclusion Criteria:

  • HER2-overexpressing patients
  • Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
  • Patients who received more than one chemotherapy line for Advanced Breast Cancer.
  • Previous treatment with exemestane or mTOR inhibitors.
  • Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
  • Radiotherapy within four weeks prior to randomization
  • Currently receiving hormone replacement therapy,

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863655

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
United States, Arkansas
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
Fayetteville, Arkansas, United States, 72703
United States, California
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
Anaheim, California, United States, 92807
Comprehensive Blood and Cancer Center Dept. of CBCC (3)
Bakersfield, California, United States, 93309
Cancer Care Associates Dept.ofCancerCareAssoc. (2)
Fresno, California, United States, 93720
Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc
Grass Valley, California, United States, 95945
Scripps Clinic SC
La Jolla, California, United States, 92121
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
Los Angeles, California, United States, 90053
Sharp Memorial Hospital SharpClinicalOncologyResearch
San Diego, California, United States, 92123
University of California San Francisco UCSF Medical Center
San Francisco, California, United States, 94101
Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ
Santa Monica, California, United States, 90404
St Joseph Heritage Healthcare Dept. of RRMG (4)
Santa Rosa, California, United States, 94503
United States, Florida
Comprehensive Cancer Center - Boca Raton Deerfield Beach
Boca Raton, Florida, United States, 33248
Florida Cancer Research Institute
Davie, Florida, United States, 33328
Florida Cancer Specialists DeptofFloridaCancerSpecialists
Fort Myers, Florida, United States, 33901
Memorial Hospital Memorial Cancer Institute
Hollywood, Florida, United States, 33021
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)
Orlando, Florida, United States, 32806
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
Florida Medical Clinic PA Dept.ofFloridaMedicalClinic
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Cancer Specialists. Drug Ship
Decatur, Georgia, United States, 30033
United States, Illinois
Rush University Medical Center Study Coordinator
Chicago, Illinois, United States, 60612
Oncology Specialists, SC Dept.of Oncology Specialists
Park Ridge, Illinois, United States, 60068-0736
United States, Indiana
Hematology Oncology of Indiana
Indianapolis, Indiana, United States, 46260
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
United States, Kansas
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
University of Louisville / James Graham Brown Cancer Center SC
Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology Oncology Clinic Hematology Oncology Clinic (2)
Baton Rouge, Louisiana, United States, 70808
Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2
Metairie, Louisiana, United States, 70006
United States, Maryland
Anne Arundel Health System Research Institute Wayson Pavilion
Annapolis, Maryland, United States, 21401
Mercy Medical Center Medical Oncology & Hematology
Baltimore, Maryland, United States, 21202
Weinberg Cancer Institute at Franklin Square Hospital
Baltimore, Maryland, United States, 21237-3998
Maryland Hematology/Oncology Associates, P.A.
Baltimore, Maryland, United States, 21237
Frederick Memorial Hospital Dept. of FMH-IRB
Frederick, Maryland, United States, 21701
Holy Cross Hospital Holy Cross
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Lahey Clinic Dept of Lahey Clinic (2)
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Fairview Southdale Medical Oncology Clinic
Edina, Minnesota, United States, 55435
United States, Missouri
St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast
St. Louis, Missouri, United States, 63141
United States, Nebraska
Southeast Nebraska Oncology Cancer Center
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Regional Cancer Care Associates Dept. of the CCHD
Cherry Hill, New Jersey, United States, 08003
Trinitas Comprehensive Cancer Center Dept. of Trinitas
Elizabeth, New Jersey, United States, 07207
United States, New Mexico
University of New Mexico Cancer Research Center Dept of UNM Cancer & Research
Albuquerque, New Mexico, United States, 87131
United States, New York
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
Lake Success, New York, United States, 11042
ProHealth Care
Lake Success, New York, United States, 11042
Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)
New York, New York, United States, 10003
Weill Cornell Medical College Weill Cornell Med. Ctr.
New York, New York, United States, 10021
Hematology Oncology Association of Rockland
Nyack, New York, United States, 10960
United States, North Carolina
Marion L. Shepard Cancer Center
Washington, North Carolina, United States, 27889
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma
Lawton, Oklahoma, United States, 73505
Cancer Care Associates SC
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Penn State University / Milton S. Hershey Medical Center Division of Oncology (2)
Hershey, Pennsylvania, United States, 17033-0850
United States, South Carolina
Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr
Charleston, South Carolina, United States, 29425
United States, Tennessee
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr.
Dallas, Texas, United States, 75390-8852
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
Fort Worth, Texas, United States, 76104
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)
Houston, Texas, United States, 77030-4009
Hope Oncology HOPE Richardson
Richardson, Texas, United States, 75080
United States, Utah
Northern Utah Cancer Associates SC
Ogden, Utah, United States, 84403-3105
Central Utah Clinic CRAD001Y2301
Provo, Utah, United States, 84604
Utah Cancer Specialists Dept.of Utah Cancer Spec. (2)
Salt Lake City, Utah, United States, 84106
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2)
Salt Lake City, Utah, United States, 84112
United States, Virginia
Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA
Reston, Virginia, United States, 20190
United States, Wisconsin
University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2)
Madison, Wisconsin, United States, 53792
Australia, Queensland
Novartis Investigative Site
Nambour, Queensland, Australia, 4560
Novartis Investigative Site
Redcliffe, Queensland, Australia, 4020
Australia, South Australia
Novartis Investigative Site
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
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Parkville, Victoria, Australia, 3002
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Parkville, Victoria, Australia, 3050
Australia, Western Australia
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Subiaco, Western Australia, Australia, 6008
Austria
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Innsbruck, Austria, A-6020
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Linz, Austria, A-4010
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Salzburg, Austria, 5020
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Wels, Austria, A-4600
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Wien, Austria, A-1090
Belgium
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1000
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Sint-Niklaas, Belgium, 9100
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Wilrijk, Belgium, 2610
Brazil
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Salvador, BA, Brazil, 41825-010
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Uberlândia, MG, Brazil, 38408-150
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Rio de Janeiro, RJ, Brazil, 20230-130
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Porto Alegre, RS, Brazil, 90560-030
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São Paulo, SP, Brazil, 01246-000
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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Cambridge, Ontario, Canada, N1R 3G2
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London, Ontario, Canada, N6A 4L6
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Newmarket, Ontario, Canada, J7Y 2P9
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St. Catharines, Ontario, Canada, L2S 0A9
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Toronto, Ontario, Canada, M4C 3E7
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Toronto, Ontario, Canada, M4N 3M5
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Weston, Ontario, Canada, M9N 1N8
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H2W 1S6
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Montreal, Quebec, Canada, H2W 1T8
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Montreal, Quebec, Canada, H4J 1C5
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Sherbrooke, Quebec, Canada, J1H 5N4
Canada
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Quebec, Canada, G1S 4L8
Czech Republic
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Olomouc, CZE, Czech Republic, 775 20
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Brno, Czech Republic, 656 53
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Praha, Czech Republic, 14044
Egypt
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Alexandria, Egypt
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Cairo, Egypt
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Menoufiya, Egypt
France
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La Roche sur Yon Cedex, France, 85925
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Le Mans, France, 72000
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Lyon Cedex, France, 69373
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Marseille, France, 13008
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Paris, France, 75010
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Rouen Cedex 1, France, 76038
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Rouen, France, 76000
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Saint-Herblain Cédex, France, 44805
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Saint-Nazaire, France, 44600
Germany
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Berlin, Germany, 10098
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Duesseldorf, Germany, 40225
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Frankfurt, Germany, 60389
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Mannheim, Germany, 68165
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Muenchen, Germany, 80637
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Muenchen, Germany, 81377
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Muenster, Germany, 48149
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Trier, Germany, 54290
Hong Kong
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Hong Kong SAR, Hong Kong
Hungary
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Budapest, Hungary, H-1122
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Szeged, Hungary, H-6720
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Szolnok, Hungary, H-5000
Italy
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Brindisi, BR, Italy, 72100
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Catania, CT, Italy, 95100
Novartis Investigative Site
Antella - Bagno a Ripoli, FI, Italy, 50011
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Macerata, MC, Italy, 62100
Novartis Investigative Site
Perugia, PG, Italy, 06129
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Torino, TO, Italy, 10126
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Terni, TR, Italy, 05100
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Saronno, Va, Italy, 21047
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Varese, VA, Italy, 21100
Japan
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Nagoya, Aichi, Japan, 464-8681
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Kashiwa, Chiba, Japan, 277-8577
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Matsuyama, Ehime, Japan, 791-0280
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Kitakyushu, Fukuoka, Japan, 802-0077
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Maebashi-city, Gunma, Japan, 371-8511
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Sapporo-city, Hokkaido, Japan, 060-8648
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Isehara-city, Kanagawa, Japan, 259-1193
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Kumamoto City, Kumamoto, Japan, 860-8556
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Kyoto-city, Kyoto, Japan, 606-8507
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Suita-city, Osaka, Japan, 565-0871
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Hidaka, Saitama, Japan, 350-1298
Novartis Investigative Site
Kitaadachi-gun, Saitama, Japan, 362-0806
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Bunkyo-ku, Tokyo, Japan, 113-8677
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Chuo-ku, Tokyo, Japan, 104-0045
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Chuo-ku, Tokyo, Japan, 104-8560
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Koto, Tokyo, Japan, 135-8550
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Fukuoka, Japan, 811-1395
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Kagoshima, Japan, 892-0833
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Osaka, Japan, 537-8511
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Osaka, Japan, 540-0006
Korea, Republic of
Novartis Investigative Site
Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
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Seoul, Korea, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 01812
Netherlands
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Alkmaar, Netherlands, 1815 JD
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Amsterdam, Netherlands, 1090 HM
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Den Haag, Netherlands, 2545 CH
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Dordrecht, Netherlands, 3318AT
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Eindhoven, Netherlands, 5631 BM
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Sittard-Geleen, Netherlands, 6162 BG
New Zealand
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Christchurch, New Zealand, 8001
Norway
Novartis Investigative Site
Lørenskog, Norway, NO-1478
Poland
Novartis Investigative Site
Krakow, Poland, 31-108
Novartis Investigative Site
Rzeszow, Poland, 35-021
Novartis Investigative Site
Warszawa, Poland, 04-125
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41017
Novartis Investigative Site
Lleida, Cataluna, Spain, 25198
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Terrassa, Catalunya, Spain, 08221
Novartis Investigative Site
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site
Mallorca, Islas Baleares, Spain, 07198
Novartis Investigative Site
Palma De Mallorca, Islas Baleares, Spain, 07120
Novartis Investigative Site
Madrid, Spain, 28033
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28046
Sweden
Novartis Investigative Site
Stockholm, Sweden, SE-118 83
Novartis Investigative Site
Stockholm, Sweden, SE-171 76
Novartis Investigative Site
Uppsala, Sweden, SE-751 85
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10400
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Novartis Investigative Site
Songkla, Thailand, 90110
Turkey
Novartis Investigative Site
Altunizade, Turkey, 34662
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Izmir, Turkey, 35040
United Kingdom
Novartis Investigative Site
Broomfield, Chelmsford, United Kingdom, CM1 7ET
Novartis Investigative Site
Truro, Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site
Cardiff, United Kingdom, CF14 2TL
Novartis Investigative Site
Nottingham, United Kingdom, NG5 1PB
Novartis Investigative Site
Sheffield, United Kingdom, S10 2SJ
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00863655     History of Changes
Other Study ID Numbers: CRAD001Y2301
2008-008698-69 ( EudraCT Number )
Study First Received: March 16, 2009
Results First Received: July 31, 2012
Last Updated: March 21, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast Cancer
Estrogen Receptor positive
ER+
exemestane
mTOR
everolimus
refractory
NSAI

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Exemestane
Anastrozole
Everolimus
Sirolimus
Estrogens
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 25, 2017