Clinical trial NCT00863655: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Estrogen Receptor positive
ER+
exemestane
mTOR
everolimus
refractory
NSAI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 724
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.
timeFrame: 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
Secondary outcomes:
measure: Overall Survival (OS) by Number of Deaths
timeFrame: up to 53 months
measure: Overall Survival (OS) by Median
timeFrame: up to 53 months
measure: Overall Response Rate (ORR)
timeFrame: up to 21 months
measure: Clinical Benefit Rate (CBR)
timeFrame: up to 21 months
measure: Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier
timeFrame: 2, 4, 6, 9 months
measure: Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30
timeFrame: Up to 21 months
measure: Proportion of Patients With Having no Overall Response Based on Investigator Assessment
timeFrame: 2, 4, 6, 9 months
measure: Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier
timeFrame: 21 months
measure: Everolimus Concentrations at Week 4
timeFrame: pre-dose, 2 hours post-dose
measure: Exemestane Concentrations at Week 4
timeFrame: predose, 2 hours post-dose
measure: Estradiol Plasma Concentrations
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
state: Arkansas
city: Anaheim
country: United States
facility: Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center Dept. of CBCC (3)
state: California
city: Fresno
country: United States
facility: Cancer Care Associates Dept.ofCancerCareAssoc. (2)
state: California
city: Grass Valley
country: United States
facility: Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc
state: California
city: La Jolla
country: United States
facility: Scripps Clinic SC
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital SharpClinicalOncologyResearch
state: California
city: San Francisco
country: United States
facility: University of California San Francisco UCSF Medical Center
state: California
city: Santa Monica
country: United States
facility: Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare Dept. of RRMG (4)
state: California
city: Boca Raton
country: United States
facility: Comprehensive Cancer Center - Boca Raton Deerfield Beach
state: Florida
city: Davie
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists
state: Florida
city: Hollywood
country: United States
facility: Memorial Hospital Memorial Cancer Institute
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic PA Dept.ofFloridaMedicalClinic
state: Florida
city: Decatur
country: United States
facility: Georgia Cancer Specialists. Drug Ship
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center Study Coordinator
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, SC Dept.of Oncology Specialists
state: Illinois
city: Indianapolis
country: United States
facility: Hematology Oncology of Indiana
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
state: Kansas
city: Louisville
country: United States
facility: University of Louisville / James Graham Brown Cancer Center SC
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic Hematology Oncology Clinic (2)
state: Louisiana
city: Metairie
country: United States
facility: Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Institute Wayson Pavilion
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center Medical Oncology & Hematology
state: Maryland
city: Baltimore
country: United States
facility: Weinberg Cancer Institute at Franklin Square Hospital
state: Maryland
city: Baltimore
country: United States
facility: Maryland Hematology/Oncology Associates, P.A.
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital Dept. of FMH-IRB
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital Holy Cross
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Dept of Lahey Clinic (2)
state: Massachusetts
city: Edina
country: United States
facility: Fairview Southdale Medical Oncology Clinic
state: Minnesota
city: St. Louis
country: United States
facility: St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Oncology Cancer Center
state: Nebraska
city: Cherry Hill
country: United States
facility: Regional Cancer Care Associates Dept. of the CCHD
state: New Jersey
city: Elizabeth
country: United States
facility: Trinitas Comprehensive Cancer Center Dept. of Trinitas
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research Center Dept of UNM Cancer & Research
state: New Mexico
city: Lake Success
country: United States
facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
state: New York
city: Lake Success
country: United States
facility: ProHealth Care
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College Weill Cornell Med. Ctr.
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Association of Rockland
state: New York
city: Washington
country: United States
facility: Marion L. Shepard Cancer Center
state: North Carolina
city: Lawton
country: United States
facility: Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates SC
state: Oklahoma
city: Hershey
country: United States
facility: Penn State University / Milton S. Hershey Medical Center Division of Oncology (2)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr.
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
state: Texas
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)
state: Texas
city: Richardson
country: United States
facility: Hope Oncology HOPE Richardson
state: Texas
city: Ogden
country: United States
facility: Northern Utah Cancer Associates SC
state: Utah
city: Provo
country: United States
facility: Central Utah Clinic CRAD001Y2301
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (2)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2)
state: Utah
city: Reston
country: United States
facility: Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2)
state: Wisconsin
city: Nambour
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Redcliffe
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Subiaco
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Wels
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Sint-Niklaas
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: BA
city: Uberlândia
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Cambridge
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: St. Catharines
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Weston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Olomouc
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Brno
country: Czech Republic
facility: Novartis Investigative Site
city: Praha
country: Czech Republic
facility: Novartis Investigative Site
city: Alexandria
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Menoufiya
country: Egypt
facility: Novartis Investigative Site
city: La Roche sur Yon Cedex
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Lyon Cedex
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Rouen Cedex 1
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint-Herblain Cédex
country: France
facility: Novartis Investigative Site
city: Saint-Nazaire
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Hong Kong SAR
country: Hong Kong
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szolnok
country: Hungary
facility: Novartis Investigative Site
city: Brindisi
country: Italy
facility: Novartis Investigative Site
state: BR
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Antella - Bagno a Ripoli
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Macerata
country: Italy
facility: Novartis Investigative Site
state: MC
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Terni
country: Italy
facility: Novartis Investigative Site
state: TR
city: Saronno
country: Italy
facility: Novartis Investigative Site
state: Va
city: Varese
country: Italy
facility: Novartis Investigative Site
state: VA
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Maebashi-city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Isehara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Hidaka
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Hwasun-gun
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollanam-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Alkmaar
country: Netherlands
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Dordrecht
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Sittard-Geleen
country: Netherlands
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
city: Lørenskog
country: Norway
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Lleida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Palma De Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Songkla
country: Thailand
facility: Novartis Investigative Site
city: Altunizade
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Broomfield
country: United Kingdom
facility: Novartis Investigative Site
state: Chelmsford
city: Truro
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
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citation: Yardley DA, Noguchi S, Pritchard KI, Burris HA 3rd, Baselga J, Gnant M, Hortobagyi GN, Campone M, Pistilli B, Piccart M, Melichar B, Petrakova K, Arena FP, Erdkamp F, Harb WA, Feng W, Cahana A, Taran T, Lebwohl D, Rugo HS. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013 Oct;30(10):870-84. doi: 10.1007/s12325-013-0060-1. Epub 2013 Oct 25.
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