Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor (BELLE-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01610284
First received: May 11, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor.


Condition Intervention Phase
Breast Cancer
Drug: BKM120 Matching placebo
Drug: Fulvestrant
Drug: BKM120
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: up to approx. 8.3 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 8 weeks after randomisation.


Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: up to approx. 32 months ] [ Designated as safety issue: No ]
    Time from date of randomization to the date of death from any cause. Patients will be followed up for the duration of the study and for an expected average of every 3 months after end of treatment.

  • Overall response rate (ORR) [ Time Frame: up to approx. 8.3 months ] [ Designated as safety issue: No ]
    Proportion of patients with best overall response of complete response (CR) or partial response (PR) based according to RECIST 1.1.Patients will be followed up for the duration of the study and for an expected average of every 8 weeks after randomisation.

  • Clinical benefit rate (CBR) [ Time Frame: up to approx. 8.3 months ] [ Designated as safety issue: No ]
    Proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1. Patients will be followed up for the duration of the study and for an expected average of every 8 weeks after randomisation.

  • Type, frequency and severity of adverse events [ Time Frame: at minimum at each study visit and up to approx. 10 months ] [ Designated as safety issue: Yes ]
    Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study.

  • Plasma concentration of BKM120 and Fulvestrant (Pharmacokinetics) [ Time Frame: Cycle 1 day 1, Cycle 1 day 15, cycle 2 day 1, cycle 2 day 2, cycle 2 day 15, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1 and cycle 6 day 1 ] [ Designated as safety issue: No ]
    PK parameters; Patients will be assessed up to approx. 6 months after randomisation date. cycle = 28 days

  • Time profile of BKM120 and Fulvestrant (Pharmacokinetics) [ Time Frame: Cycle 1 day 1, Cycle 1 day 15, cycle 2 day 1, cycle 2 day 2, cycle 2 day 15, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1 and cycle 6 day 1 ] [ Designated as safety issue: No ]
    PK parameters; Patients will be assessed up to approx. 6 months after randomisation date. cycle = 28 days

  • Patient reported outcomes for global health status/QOL [ Time Frame: Cycle 1 day 1, cycle 1 day 15, 6 weeks after randomisation and then every 8 weeks until end of treatment ] [ Designated as safety issue: No ]
    Time to definitive deterioration in global health status/QOL; Change from baseline in global health status/Quality of Life (QOL). Patients will be assessed up to approx. 8.3 months


Estimated Enrollment: 1200
Study Start Date: August 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM120 and fulvestrant
BKM120 100mg given daily and fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter. Treatment will be given until disease progression or as described in the protocol
Drug: Fulvestrant
Fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter
Drug: BKM120
BKM120 100mg, daily oral capsules
Active Comparator: Placebo and fulvestrant
BKM120 matching placebo given daily and fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter. Treatment will be given until disease progression or as described in the protocol
Drug: BKM120 Matching placebo
BKM120 matching placebo, daily oral
Drug: Fulvestrant
Fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced or metastatic breast cancer
  • HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
  • Postmenopausal woman
  • A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
  • Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
  • Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
  • Adequate bone marrow and organ function defined by laboratory values

Exclusion Criteria:

  • Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
  • More than one prior chemotherapy line for metastatic disease
  • Symptomatic brain metastases
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease as defined in the protocol
  • Certain scores on an anxiety and depression mood questionnaires

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: NCT01610284

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2) Recruiting
Mobile, Alabama, United States, 36688
Contact: Micah-Shea McKibben    251-445-9870    mmckibben@health.southalabama.edu   
Principal Investigator: Windy Dean-Colomb         
United States, Arizona
Arizona Oncology Associates Dept of Oncology Active, not recruiting
Phoenix, Arizona, United States
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp Active, not recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Shapiro & Stafford & Yee & Polanski Study Coordinator Active, not recruiting
Arcadia, California, United States, 91007
Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer Withdrawn
Burbank, California, United States, 91505-6866
City of Hope National Medical Center CH Med Ctr Withdrawn
Duarte, California, United States, 91010-3000
Compassionate Cancer Care Medical Group CCCMG Recruiting
Fountain Valley, California, United States, 92708
Contact: Catherine Etheridge    714-698-0300    catherine.etheridge@clinicaidusa.com   
Principal Investigator: Haresh Jhangiani         
Cancer Care Associates Dept.ofCancerCareAssoc. Recruiting
Fresno, California, United States, 93720
Contact: Julie Miyake    559-326-1222    hunterj@ccaonc.com   
Principal Investigator: Steven Hager         
St. Jude Heritage Medical Group Virginia Crosson Cancer Center Active, not recruiting
Fullerton, California, United States, 92835
University of California San Diego UCSD 3 Active, not recruiting
La Jolla, California, United States, 92093-0658
Coast Hematology Oncology Associates Withdrawn
Long Beach, California, United States, 90806
Los Angeles Hematology/Oncology Medical Group LA Cancer Network Active, not recruiting
Los Angeles, California, United States, 90017
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3) Active, not recruiting
Los Angeles, California, United States, 90053
University of California at Los Angeles Dept. of UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Teresa M. Mercado    +1 310 825 4493    tmercado@mednet.ucla.edu   
Principal Investigator: Sara Alsterlind Hurvitz         
Ventura County Hematology and Oncology PMK Medical Group Active, not recruiting
Oxnard, California, United States, 93030
Coastal Integrative Cancer Care Active, not recruiting
San Luis Obispo, California, United States, 93401
Santa Barbara Hematolgy Oncology Medical Group Active, not recruiting
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation Active, not recruiting
Santa Maria, California, United States, 93454
Redwood Regional Medical Group - Santa Rosa Dept. of RRMG (4) Active, not recruiting
Santa Rosa, California, United States, 94503
Granada Hills Cancer Center Active, not recruiting
Valencia, California, United States, 91355
United States, Colorado
Kaiser Permanente Northwest Kaiser Active, not recruiting
Denver, Colorado, United States
St. Mary's Cancer Center St Mary's Withdrawn
Grand Junction, Colorado, United States, 81502
Rocky Mountain Cancer Centers RMCC Active, not recruiting
Greenwood Village, Colorado, United States
United States, Connecticut
Norwalk Hospital Whittingham Cancer Ctr. Withdrawn
Norwalk, Connecticut, United States, 06856
United States, Florida
Memorial Regional Cancer Center MRCC Recruiting
Hollywood, Florida, United States, 33021
Contact: Nicolas Chow    954-265-2615    NChow@mhs.net   
Principal Investigator: Alejandra Perez         
Cancer Specialists of North Florida SC - F2302 Recruiting
Jacksonville, Florida, United States, 32258
Contact: Jessica Schllesinger    904-272-3139    jessica.schllesinger@csnf.us   
Principal Investigator: Suprith Badarinath         
Cancer Center of South Florida Withdrawn
Lake Worth, Florida, United States, 33461
University of Miami Univ Miami 2 Active, not recruiting
Miami, Florida, United States, 33136
Cancer Centers of Florida PA Cancer Center of Florida Withdrawn
Ocoee, Florida, United States, *see dep*
MD Anderson Cancer Center - Orlando MD Orlando Completed
Orlando, Florida, United States, 32806
United States, Georgia
Georgia Cancer Specialists. SC Active, not recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
Cancer Care and Hematology Specialists of Chicagoland Niles Active, not recruiting
*see Various Departments*, Illinois, United States
Rush University Medical Center Rush2 Withdrawn
Chicago, Illinois, United States, 60612
Advocate Illinois MasonicMedical Cent/Creticos Cancer Center Dept. of Creticos Cancer Cente Withdrawn
Chicago, Illinois, United States, 60657
Vanguard Health Chicago Withdrawn
Chicago, Illinois, United States, 60640
North Shore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Nicole Jeka    847-570-2109    njeka@northshore.org   
Principal Investigator: Douglas E. Merkel         
Cadence Health Active, not recruiting
Geneva, Illinois, United States, 60134
United States, Indiana
Central Indiana Cancer Centers CICC - East (2) Withdrawn
Indianapolis, Indiana, United States, 46227
United States, Kansas
Cancer Center of Kansas CCK Active, not recruiting
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
University of Louisville / James Graham Brown Cancer Center SC Withdrawn
Louisville, Kentucky, United States, 40202
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Sidney/John Hopkins Active, not recruiting
Baltimore, Maryland, United States, 21231
Mercy Medical Center Mercy Medical SC Active, not recruiting
Baltimore, Maryland, United States, 21202
Frederick Memorial Hospital Fred. Mem. Hosp. Active, not recruiting
Frederick, Maryland, United States, 21701
Associates in Oncology/Hematology, P.C. SC Active, not recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Massachusetts General Hospital SC Recruiting
Boston, Massachusetts, United States, 02114
Contact: Amanda Manoogian    617-726-1634    amanoogian1@partners.org   
Principal Investigator: Aditya Bardia         
United States, Michigan
West Michigan Cancer Center Dept of Oncology Withdrawn
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Fairview Southdale Medical Oncology Clinic Completed
Edina, Minnesota, United States, 55435
Park Nicollet Institute Dept Onc Withdrawn
St. Louis Park, Minnesota, United States, 55416
United States, Mississippi
Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint Active, not recruiting
Tupelo, Mississippi, United States, 38801
United States, Missouri
Missouri Cancer Associates Dept.ofMissouriCancerAssoc. Withdrawn
Columbia, Missouri, United States, 65201
Research Medical Center Reseach Med Center (6) Withdrawn
Kansas City, Missouri, United States, 64132
Washington University School of Medicine Wash Univ School of Med Active, not recruiting
St. Louis, Missouri, United States, 63110
United States, Nebraska
Southeast Nebraska Oncology Withdrawn
Lincoln, Nebraska, United States, 68510
Southeast Nebraska Oncology Cancer Center Withdrawn
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Meridian Health Systems Active, not recruiting
Brick, New Jersey, United States, 08724
Saint Peter's University Hospital Withdrawn
New Brunswick, New Jersey, United States, 08901
The Valley Hospital / Luckow Pavillion Active, not recruiting
Paramus, New Jersey, United States, 07652
United States, New York
NYU Langone Arena Oncology SC Active, not recruiting
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center Dept Onc Active, not recruiting
New York, New York, United States, 10021
Weill Cornell Medical Center Weill Cornell Breast Center Recruiting
New York, New York, United States, 10021
Contact: Allison Knutson    212-821-0749    alk2019@med.cornell.edu   
Principal Investigator: Tessa Cigler         
University of Rochester Medical Center Univ Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Melissa Worman    583-273-1876    Melissa_worman@urmc.rochester.edu   
Principal Investigator: Michelle Shayne         
Stony Brook University Medical Center Cancer Center Withdrawn
Stony Brook, New York, United States, 11794
United States, North Carolina
Levine Cancer Institute Levine Cancer Institute Withdrawn
Charlotte, North Carolina, United States, 28203
Wake Forest University Baptist Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Mid Dakota Clinic, P.C. Dept of Oncology Withdrawn
Bismark, North Dakota, United States, 58501
United States, Ohio
Case Western Reserve SC Active, not recruiting
Cleveland, Ohio, United States, 44106-5000
United States, Oregon
Cancer Care of the Cascades St. Charles Medical Center Withdrawn
Bend, Oregon, United States, 97701
Northwest Cancer Specialists Portland Loc Active, not recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
St. Luke's Hospital and Health Network St Luke's (2) Active, not recruiting
Bethlehem, Pennsylvania, United States
Penn State University / Milton S. Hershey Medical Center Division of Oncology Withdrawn
Hershey, Pennsylvania, United States, 17033-0850
Western Pennsylvania Cancer Institute /Western Penn Hospital Dept Onc Withdrawn
Pittsburgh, Pennsylvania, United States, 15224
Abington Hematology Oncology Associates, Inc Abington Hem Onc Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Diane Foley       dfoley@abingtonhemeonc.com   
Principal Investigator: Pallav Mehta         
United States, South Carolina
Charleston Hematology Oncology Association PA Active, not recruiting
Charleston, South Carolina, United States, 29414
United States, Tennessee
Tennessee Cancer Specialists Center for Biomedical Research Active, not recruiting
Knoxville, Tennessee, United States, 37909
Vanderbilt University Medical Center Vanderbilt - Thompson Ln Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology, P.A. TX Onc - Med City Dallas Active, not recruiting
Dallas, Texas, United States, 75251
Texas Oncology, P.A. TX Onc - Bedford Active, not recruiting
Dallas, Texas, United States, 75251
Texas Oncology, P.A. TX Onc - Southwest Active, not recruiting
Dallas, Texas, United States, 75251
Texas Oncology, P.A. Midtown Active, not recruiting
Dallas, Texas, United States, 75251
US Oncology Central Monitoring US Oncology Central Pharmacy Withdrawn
Dallas, Texas, United States, 75246
Oncology Consultants Oncology Consultants, P.A. Recruiting
Houston, Texas, United States, 77024
Contact: Lafit Ramos    713-827-9525    lramos@oncologyconsultants.com   
Principal Investigator: Luis T Campos         
Texas Oncology P.A. - Plano East Withdrawn
Plano, Texas, United States, 75075
Cancer Therapy & Research Center / UT Health Science Center Institute for Drug Development Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) Completed
Salt Lake City, Utah, United States, 84106
United States, Virginia
Oncology Hematology Associates of Southeast Virginia Salem VA Branch Active, not recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Columbia Basin Hematology Columbia Basin Active, not recruiting
Kennewick, Washington, United States, 99336
Cancer Care Northwest CC Northwest- Spokane South Withdrawn
Spokane, Washington, United States, 99202
United States, West Virginia
West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology Active, not recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Cancer TEAM Bellin Health Belin Health Terminated
Green Bay, Wisconsin, United States, 54313
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3 Active, not recruiting
Madison, Wisconsin, United States, 53792-6164
Dean Health System Dean Hematology Oncology Completed
Madison, Wisconsin, United States, 53717
Argentina
Novartis Investigative Site Active, not recruiting
Mar del Plata, Buenos Aires, Argentina, B7600CTO
Novartis Investigative Site Active, not recruiting
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site Active, not recruiting
Buenos Aires, Argentina, C1050AAK
Novartis Investigative Site Active, not recruiting
Tucuman, Argentina, T4000IAK
Australia, Australian Capital Territory
Novartis Investigative Site Withdrawn
Canberra, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Novartis Investigative Site Active, not recruiting
Sydney, New South Wales, Australia, 2060
Novartis Investigative Site Withdrawn
Westmead, New South Wales, Australia, 2145
Novartis Investigative Site Active, not recruiting
Woollongong, New South Wales, Australia, 2500
Australia, Queensland
Novartis Investigative Site Active, not recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Novartis Investigative Site Active, not recruiting
Clayton, Victoria, Australia, 3168
Novartis Investigative Site Active, not recruiting
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Novartis Investigative Site Active, not recruiting
Murdoch, Western Australia, Australia, 6150
Novartis Investigative Site Active, not recruiting
Perth, Western Australia, Australia, 6005
Austria
Novartis Investigative Site Active, not recruiting
Linz, Austria, 4010
Novartis Investigative Site Active, not recruiting
Salzburg, Austria, 5020
Novartis Investigative Site Active, not recruiting
Wien, Austria, A-1090
Belgium
Novartis Investigative Site Completed
Brussel, Belgium, 1090
Novartis Investigative Site Active, not recruiting
Bruxelles, Belgium, 1000
Novartis Investigative Site Active, not recruiting
Charleroi, Belgium, 6000
Novartis Investigative Site Active, not recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Active, not recruiting
Liege, Belgium, 4000
Novartis Investigative Site Active, not recruiting
Namur, Belgium, 5000
Novartis Investigative Site Active, not recruiting
Wilrijk, Belgium, 2610
Brazil
Novartis Investigative Site Active, not recruiting
Belo Horizonte, MG, Brazil, 30150-270
Novartis Investigative Site Active, not recruiting
Curitiba, PR, Brazil, 81520-060
Novartis Investigative Site Withdrawn
Rio de Janiero, RJ, Brazil, 20231-050
Novartis Investigative Site Active, not recruiting
Natal, RN, Brazil, 59040-000
Novartis Investigative Site Active, not recruiting
Ijuí, RS, Brazil, 98700-000
Novartis Investigative Site Withdrawn
Porto Alegre, RS, Brazil, 90020-090
Novartis Investigative Site Active, not recruiting
Barretos, SP, Brazil, 14784-400
Novartis Investigative Site Active, not recruiting
Sorocaba, SP, Brazil
Novartis Investigative Site Withdrawn
São Paulo, SP, Brazil, 04039-32
Novartis Investigative Site Active, not recruiting
São Paulo, SP, Brazil, 01246-000
Canada, Alberta
Novartis Investigative Site Active, not recruiting
Calgary, Alberta, Canada, T2N 4N2
Novartis Investigative Site Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Novartis Investigative Site Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Novartis Investigative Site Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Novartis Investigative Site Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Novartis Investigative Site Active, not recruiting
Cambridge, Ontario, Canada, N1R 3G2
Novartis Investigative Site Active, not recruiting
London, Ontario, Canada, N6A 4L6
Novartis Investigative Site Active, not recruiting
Newmarket, Ontario, Canada, J7Y 2P9
Novartis Investigative Site Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site Withdrawn
Toronto, Ontario, Canada, M5B 1N9
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site Active, not recruiting
Laval, Quebec, Canada, H7M 3L9
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Novartis Investigative Site Active, not recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Canada
Novartis Investigative Site Active, not recruiting
Quebec, Canada, G1S 4L8
China, Beijing
Novartis Investigative Site Withdrawn
Beijing, Beijing, China, 100730
China, Guangdong
Novartis Investigative Site Withdrawn
Guangzhou, Guangdong, China, 510515
China, Hebei
Novartis Investigative Site Withdrawn
Shijiazhuang, Hebei, China, 050011
China, Heilongjiang
Novartis Investigative Site Active, not recruiting
Harbin, Heilongjiang, China, 150081
China, Hubei
Novartis Investigative Site Withdrawn
Wuhan, Hubei, China, 430030
China, Hunan
Novartis Investigative Site Active, not recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Novartis Investigative Site Active, not recruiting
Nanjing, Jiangsu, China, 210009
China, Liaoning
Novartis Investigative Site Active, not recruiting
Shengyang, Liaoning, China, 110042
China, Shanghai
Novartis Investigative Site Active, not recruiting
Shanghai, Shanghai, China, 200032
China, Sichuan
Novartis Investigative Site Withdrawn
Chengdu, Sichuan, China, 610041
Novartis Investigative Site Active, not recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Novartis Investigative Site Active, not recruiting
Hangzhou, Zhejiang, China, 310022
Novartis Investigative Site Withdrawn
Hangzhou, Zhejiang, China, 310006
China
Novartis Investigative Site Withdrawn
Beijing, China, 100021
Novartis Investigative Site Completed
Beijing, China, 100039
Novartis Investigative Site Active, not recruiting
Guangzhou, China, 510060
Novartis Investigative Site Active, not recruiting
Shanghai, China, 200025
Czech Republic
Novartis Investigative Site Active, not recruiting
Olomouc, CZE, Czech Republic, 775 20
Novartis Investigative Site Recruiting
Brno, Czech Republic, 65653
Novartis Investigative Site Active, not recruiting
Brno - Bohunice, Czech Republic, 625 00
Novartis Investigative Site Completed
Praha 10, Czech Republic, 100 34
France
Novartis Investigative Site Active, not recruiting
Angers Cedex 9, France, 49933
Novartis Investigative Site Active, not recruiting
Avignon Cedex, France, 84082
Novartis Investigative Site Active, not recruiting
Besançon cedex, France, 25030
Novartis Investigative Site Active, not recruiting
Bordeaux, France, 33076
Novartis Investigative Site Active, not recruiting
Caen Cedex, France, 14021
Novartis Investigative Site Active, not recruiting
Clermont-Ferrand, France, 63011
Novartis Investigative Site Active, not recruiting
Dijon Cedex, France, 21034
Novartis Investigative Site Withdrawn
L'isle sur Doubs, France, 25250
Novartis Investigative Site Withdrawn
La Roche sur Yon cedex 9, France, 85925
Novartis Investigative Site Active, not recruiting
Le Mans Cedex, France, 72015
Novartis Investigative Site Active, not recruiting
Lille Cedex, France, 59020
Novartis Investigative Site Withdrawn
Lyon Cedex, France, 69373
Novartis Investigative Site Active, not recruiting
Montpellier, France, 34094
Novartis Investigative Site Active, not recruiting
Nice Cedex 2, France, 06189
Novartis Investigative Site Active, not recruiting
Paris, France, 75010
Novartis Investigative Site Active, not recruiting
Paris, France, 75231
Novartis Investigative Site Active, not recruiting
Rouen Cedex 1, France, 76038
Novartis Investigative Site Active, not recruiting
Saint Priest en Jarez Cedex, France, 42271
Novartis Investigative Site Active, not recruiting
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site Active, not recruiting
Strasbourg cedex, France, 67085
Novartis Investigative Site Active, not recruiting
Toulouse Cedex 9, France, 31059
Novartis Investigative Site Active, not recruiting
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Withdrawn
Amberg, Germany, 92224
Novartis Investigative Site Withdrawn
Berlin, Germany, 10098
Novartis Investigative Site Withdrawn
Berlin, Germany, 10367
Novartis Investigative Site Withdrawn
Dortmund, Germany, 44263
Novartis Investigative Site Terminated
Essen, Germany, 45147
Novartis Investigative Site Withdrawn
Halle, Germany, 06110
Novartis Investigative Site Active, not recruiting
Hamburg, Germany, 20249
Novartis Investigative Site Terminated
Hannover, Germany, 30177
Novartis Investigative Site Active, not recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Active, not recruiting
Kiel, Germany, 24105
Novartis Investigative Site Withdrawn
Koblenz, Germany, 56068
Novartis Investigative Site Active, not recruiting
Langen, Germany, 63225
Novartis Investigative Site Active, not recruiting
Luebeck, Germany, 23563
Novartis Investigative Site Active, not recruiting
Magdeburg, Germany, 39108
Novartis Investigative Site Active, not recruiting
Mainz, Germany, 55131
Novartis Investigative Site Terminated
Mannheim, Germany, 68165
Novartis Investigative Site Active, not recruiting
Mühlhausen, Germany, 99974
Novartis Investigative Site Active, not recruiting
München, Germany, 80638
Novartis Investigative Site Active, not recruiting
Recklinghausen, Germany, 45657
Novartis Investigative Site Withdrawn
Rodgau, Germany, 63110
Novartis Investigative Site Active, not recruiting
Saarbrücken, Germany, 66113
Novartis Investigative Site Active, not recruiting
Velbert, Germany, 42551
Novartis Investigative Site Active, not recruiting
Würzburg, Germany, 97080
Greece
Novartis Investigative Site Active, not recruiting
Heraklion Crete, GR, Greece, 711 10
Novartis Investigative Site Active, not recruiting
Patra - RIO, GR, Greece, 265 04
Novartis Investigative Site Active, not recruiting
Thessaloniki, GR, Greece, 546 45
Novartis Investigative Site Active, not recruiting
Athens, Greece, 115 28
Hungary
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, H-1122
Novartis Investigative Site Active, not recruiting
Debrecen, Hungary, 4032
Novartis Investigative Site Active, not recruiting
Miskolc, Hungary, 3526
Novartis Investigative Site Active, not recruiting
Szolnok, Hungary, H-5000
Israel
Novartis Investigative Site Active, not recruiting
Haifa, Israel, 31096
Novartis Investigative Site Active, not recruiting
Jerusalem, Israel, 91120
Novartis Investigative Site Active, not recruiting
Petach Tikva, Israel, 49100
Novartis Investigative Site Active, not recruiting
Ramat Gan, Israel
Novartis Investigative Site Active, not recruiting
Tel-Aviv, Israel, 64239
Italy
Novartis Investigative Site Withdrawn
Bergamo, BG, Italy, 24128
Novartis Investigative Site Withdrawn
Brindisi, BR, Italy, 72100
Novartis Investigative Site Withdrawn
Brescia, BS, Italy, 25124
Novartis Investigative Site Withdrawn
Cagliari, CA, Italy, 09100
Novartis Investigative Site Terminated
Cuneo, CN, Italy, 12100
Novartis Investigative Site Active, not recruiting
Cremona, CR, Italy, 26100
Novartis Investigative Site Active, not recruiting
Catanzaro, CZ, Italy, 88100
Novartis Investigative Site Active, not recruiting
Meldola, FC, Italy, 47014
Novartis Investigative Site Active, not recruiting
Firenze, FI, Italy, 50134
Novartis Investigative Site Completed
Lido di Camaiore, LU, Italy, 55041
Novartis Investigative Site Active, not recruiting
Macerata, MC, Italy, 62100
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20122
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20162
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Active, not recruiting
Rozzano, MI, Italy, 20089
Novartis Investigative Site Active, not recruiting
Pisa, PI, Italy, 56126
Novartis Investigative Site Active, not recruiting
Aviano, PN, Italy, 33081
Novartis Investigative Site Withdrawn
Reggio Emilia, RE, Italy, 42100
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00161
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00189
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00128
Novartis Investigative Site Active, not recruiting
Rimini, RN, Italy, 47900
Novartis Investigative Site Withdrawn
Candiolo, TO, Italy, 10060
Novartis Investigative Site Completed
Torino, TO, Italy, 10126
Novartis Investigative Site Active, not recruiting
Mirano, VE, Italy, 30035
Novartis Investigative Site Active, not recruiting
Bologna, Italy, 40138
Novartis Investigative Site Active, not recruiting
Napoli, Italy, 80131
Japan
Novartis Investigative Site Active, not recruiting
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site Completed
Kashiwa, Chiba, Japan
Novartis Investigative Site Active, not recruiting
Maebashi-city, Gunma, Japan, 371-8511
Novartis Investigative Site Active, not recruiting
Sapporo, Hokkaido, Japan
Novartis Investigative Site Completed
Isehara-city, Kanagawa, Japan, 259-1193
Novartis Investigative Site Active, not recruiting
Yokohama, Kanagawa, Japan, 241-8515
Novartis Investigative Site Active, not recruiting
Kumamoto City, Kumamoto, Japan, 860-8556
Novartis Investigative Site Active, not recruiting
Kyoto-city, Kyoto, Japan, 606-8507
Novartis Investigative Site Active, not recruiting
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site Active, not recruiting
Koto, Tokyo, Japan, 135-8550
Novartis Investigative Site Active, not recruiting
Fukuoka, Japan, 811-1395
Novartis Investigative Site Active, not recruiting
Osaka, Japan, 537-8511
Novartis Investigative Site Active, not recruiting
Osaka, Japan, 540-0006
Korea, Republic of
Novartis Investigative Site Active, not recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 443-721
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Republic of, 137-701
Netherlands
Novartis Investigative Site Active, not recruiting
Dordrecht, Netherlands, 3318AT
Novartis Investigative Site Active, not recruiting
Nijmegen, Netherlands, 6525 GA
Peru
Novartis Investigative Site Withdrawn
Chiclayo, Lambayeque, Peru, 140
Novartis Investigative Site Active, not recruiting
Surquillo, Lima, Peru, 34
Novartis Investigative Site Withdrawn
Arequipa, Peru
Novartis Investigative Site Withdrawn
Lima, Peru
Poland
Novartis Investigative Site Active, not recruiting
Kraków, Poland
Novartis Investigative Site Active, not recruiting
Olsztyn, Poland, 10-513
Novartis Investigative Site Active, not recruiting
Warszawa, Poland, 02-776
Russian Federation
Novartis Investigative Site Withdrawn
Nizhniy Novgorod, Russia, Russian Federation, 603081
Novartis Investigative Site Active, not recruiting
St.- Petersburg, Russia, Russian Federation, 197022
Novartis Investigative Site Withdrawn
Moscow, Russian Federation, 115478
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 115998
Novartis Investigative Site Active, not recruiting
St. Petersburg, Russian Federation, 197758
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Slovakia
Novartis Investigative Site Active, not recruiting
Bratislava, Slovak Republic, Slovakia, 83310
Novartis Investigative Site Active, not recruiting
Kosice, Slovakia, 040 91
South Africa
Novartis Investigative Site Withdrawn
Bloemfontein, South Africa, 9300
Novartis Investigative Site Active, not recruiting
Johannesburg, South Africa, 2000
Novartis Investigative Site Recruiting
Johannesburg, South Africa, 2196
Novartis Investigative Site Active, not recruiting
Parktown, South Africa, 2193
Spain
Novartis Investigative Site Active, not recruiting
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site Active, not recruiting
Jaen, Andalucia, Spain, 23007
Novartis Investigative Site Active, not recruiting
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site Active, not recruiting
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site Active, not recruiting
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Active, not recruiting
Sevilla, Andalucia, Spain, 41014
Novartis Investigative Site Active, not recruiting
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site Withdrawn
Santander, Cantabria, Spain, 39008
Novartis Investigative Site Terminated
Toledo, Castilla la Mancha, Spain, 45004
Novartis Investigative Site Terminated
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Active, not recruiting
Barcelona, Cataluña, Spain, 08024
Novartis Investigative Site Active, not recruiting
Tarragona, Cataluña, Spain, 43007
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Withdrawn
Valencia, Comunidad Valenciana, Spain, 46017
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Withdrawn
Las Palmas de Gran Canaria, Las Palmas de G.C, Spain, 35010
Novartis Investigative Site Active, not recruiting
Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, Spain, 35016
Novartis Investigative Site Withdrawn
Alcala de Henares, Madrid, Spain, 28805
Novartis Investigative Site Active, not recruiting
Majadanonda, Madrid, Spain, 28220
Novartis Investigative Site Active, not recruiting
San Sebastian de los Reyes, Madrid, Spain, 28700
Novartis Investigative Site Active, not recruiting
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Active, not recruiting
Elche, Murcia, Spain, 03202
Novartis Investigative Site Withdrawn
Bilbao, Pais Vasco, Spain, 48013
Novartis Investigative Site Active, not recruiting
Barcelona, Spain, 08025
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28009
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28050
Novartis Investigative Site Withdrawn
Madrid, Spain, 28041
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28040
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28046
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28033
Novartis Investigative Site Active, not recruiting
Zaragoza, Spain, 50009
Switzerland
Novartis Investigative Site Active, not recruiting
Bellinzona, Switzerland, 6500
Novartis Investigative Site Active, not recruiting
Genève, Switzerland, 1211
Novartis Investigative Site Active, not recruiting
Zuerich, Switzerland
Taiwan
Novartis Investigative Site Active, not recruiting
Kaohsiung, Taiwan, 833
Novartis Investigative Site Active, not recruiting
Kaohsiung, Taiwan, 807
Novartis Investigative Site Active, not recruiting
Taichung, Taiwan, 40447
Novartis Investigative Site Active, not recruiting
Taipei, Taiwan
Novartis Investigative Site Active, not recruiting
Taipei, Taiwan, 10048
Thailand
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10400
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10700
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10330
United Kingdom
Novartis Investigative Site Active, not recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site Withdrawn
Birmingham, United Kingdom, B152WB
Novartis Investigative Site Active, not recruiting
Bournemouth, United Kingdom, BH7 7DW
Novartis Investigative Site Active, not recruiting
Derby, United Kingdom, DE22 3NE
Novartis Investigative Site Completed
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site Active, not recruiting
Liverpool, United Kingdom, L7 8XP
Novartis Investigative Site Active, not recruiting
London, United Kingdom, SE1 9RT
Novartis Investigative Site Active, not recruiting
London, United Kingdom, WC1E 6HX
Novartis Investigative Site Active, not recruiting
Manchester, United Kingdom, M20 2BX
Novartis Investigative Site Active, not recruiting
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01610284     History of Changes
Other Study ID Numbers: CBKM120F2302, 2011-005524-17
Study First Received: May 11, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Brazil: ANVISA
Italy: National Institute of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Taiwan : Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Japan: Pharmaceuticals and Medical Devices Agency
Greece: National Organization of Medicine
China: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Thailand: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
South Africa: Department of Health
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Israel: Ministry of Health
Peru: Ministry of Health

Keywords provided by Novartis:
Breast cancer
Hormone receptor positive
HER2-negative
Metastatic
Locally advanced
PI3K
Fulvestrant
Refractory
Aromatase inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014