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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01610284
First received: May 11, 2012
Last updated: August 7, 2015
Last verified: August 2015
  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


Enrollment: 1148
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

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)
Mobile, Alabama, United States, 36688
United States, Arizona
Arizona Oncology Associates Dept of Oncology
Phoenix, Arizona, United States
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, California
Shapiro & Stafford & Yee & Polanski Study Coordinator
Arcadia, California, United States, 91007
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Fullerton, California, United States, 92835
University of California San Diego UCSD 3
La Jolla, California, United States, 92093-0658
Los Angeles Hematology/Oncology Medical Group LA Cancer Network
Los Angeles, California, United States, 90017
University of California at Los Angeles Dept. of UCLA
Los Angeles, California, United States, 90095
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)
Los Angeles, California, United States, 90053
Ventura County Hematology and Oncology PMK Medical Group
Oxnard, California, United States, 93030
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Santa Barbara Hematolgy Oncology Medical Group
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
St Joseph Heritage Healthcare Dept. of RRMG (4)
Santa Rosa, California, United States, 94503
Granada Hills Cancer Center
Valencia, California, United States, 91355
United States, Colorado
Kaiser Permanente Northwest Kaiser
Denver, Colorado, United States
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
United States, Florida
Memorial Regional Cancer Center MRCC
Hollywood, Florida, United States, 33021
Cancer Specialists of North Florida SC - F2302
Jacksonville, Florida, United States, 32258
University of Miami Univ Miami 2
Miami, Florida, United States, 33136
MD Anderson Cancer Center - Orlando MD Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Georgia Cancer Specialists. SC
Decatur, Georgia, United States, 30033
United States, Illinois
Cancer Care and Hematology Specialists of Chicagoland Niles
*see Various Departments*, Illinois, United States
Cadence Health
Geneva, Illinois, United States, 60134
United States, Kansas
Cancer Center of Kansas CCK
Wichita, Kansas, United States, 67214-3728
United States, Maryland
Mercy Medical Center Mercy Medical SC
Baltimore, Maryland, United States, 21202
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Sidney/John Hopkins
Baltimore, Maryland, United States, 21231
Frederick Memorial Hospital Fred. Mem. Hosp.
Frederick, Maryland, United States, 21701
Maryland Oncology Hematology, P.A. SC
Rockville, Maryland, United States, 20850
United States, Massachusetts
Massachusetts General Hospital SC
Boston, Massachusetts, United States, 02114
United States, Mississippi
Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint
Tupelo, Mississippi, United States, 38801
United States, Missouri
Washington University School of Medicine Regulatory
St. Louis, Missouri, United States, 63110
United States, New Jersey
Meridian Health Systems
Brick, New Jersey, United States, 08724
The Valley Hospital / Luckow Pavillion
Paramus, New Jersey, United States, 07652
United States, New York
NYU Langone Arena Oncology SC
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center Dept Onc
New York, New York, United States, 10021
University of Rochester Medical Center Univ Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve SC
Cleveland, Ohio, United States, 44106-5000
United States, Oregon
Northwest Cancer Specialists Portland Loc
Portland, Oregon, United States, 97210
United States, Pennsylvania
St. Luke's Hospital and Health Network St Luke's (2)
Bethlehem, Pennsylvania, United States
United States, South Carolina
Charleston Hematology Oncology Association PA
Charleston, South Carolina, United States, 29414
United States, Tennessee
Tennessee Cancer Specialists Center for Biomedical Research
Knoxville, Tennessee, United States, 37909
Vanderbilt University Medical Center Vanderbilt - Thompson Ln
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology Midtown
Dallas, Texas, United States, 75251
Texas Oncology TX Onc - Bedford
Dallas, Texas, United States, 75251
Texas Oncology TX Onc - Med City Dallas
Dallas, Texas, United States, 75251
Texas Oncology TX Onc - Southwest
Dallas, Texas, United States, 75251
Cancer Therapy & Research Center / UT Health Science Center Institute for Drug Development
San Antonio, Texas, United States, 78229
United States, Utah
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City, Utah, United States, 84106
United States, Virginia
Oncology Hematology Associates of Southeast Virginia Salem VA Branch
Roanoke, Virginia, United States, 24014
United States, Washington
Columbia Basin Hematology & Oncology Columbia Basin
Kennewick, Washington, United States, 99336
United States, West Virginia
West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Cancer TEAM Bellin Health Belin Health
Green Bay, Wisconsin, United States, 54313
Dean Health System Dean Hematology Oncology
Madison, Wisconsin, United States, 53717
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
Madison, Wisconsin, United States, 53792-6164
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Montpellier Cedex 5, France, 34298
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Nice Cedex 2, France, 06189
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Paris, France, 75231
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Paris, France, 75010
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Rouen Cedex 1, France, 76038
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Saint Priest en Jarez Cedex, France, 42271
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Strasbourg cedex, France, 67085
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Germany
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Essen, Germany, 45147
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Heidelberg, Germany, 69120
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Langen, Germany, 63225
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Luebeck, Germany, 23563
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Magdeburg, Germany, 39108
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Mainz, Germany, 55131
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Mannheim, Germany, 68165
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Mühlhausen, Germany, 99974
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München, Germany, 80638
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Recklinghausen, Germany, 45657
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Saarbrücken, Germany, 66113
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Velbert, Germany, 42551
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Würzburg, Germany, 97080
Greece
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Heraklion Crete, GR, Greece, 711 10
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Patra - RIO, GR, Greece, 265 04
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Thessaloniki, GR, Greece, 546 45
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Athens, Greece, 115 28
Hungary
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Budapest, Hungary, H-1122
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Miskolc, Hungary, 3526
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Szolnok, Hungary, H-5000
Israel
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Haifa, Israel, 31096
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Petach Tikva, Israel, 49100
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Ramat Gan, Israel
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Tel-Aviv, Israel, 64239
Italy
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Cuneo, CN, Italy, 12100
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Catanzaro, CZ, Italy, 88100
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Meldola, FC, Italy, 47014
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Firenze, FI, Italy, 50134
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Lido di Camaiore, LU, Italy, 55041
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Macerata, MC, Italy, 62100
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Milano, MI, Italy, 20162
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Milano, MI, Italy, 20133
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Milano, MI, Italy, 20141
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Milano, MI, Italy, 20122
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Rozzano, MI, Italy, 20089
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Pisa, PI, Italy, 56126
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Aviano, PN, Italy, 33081
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Roma, RM, Italy, 00161
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Roma, RM, Italy, 00128
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Rimini, RN, Italy, 47900
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Torino, TO, Italy, 10126
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Mirano, VE, Italy, 30035
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Bologna, Italy, 40138
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Japan
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Nagoya, Aichi, Japan, 464-8681
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Kashiwa, Chiba, Japan
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Maebashi-city, Gunma, Japan, 371-8511
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Sapporo, Hokkaido, Japan
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Isehara-city, Kanagawa, Japan, 259-1193
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Yokohama, Kanagawa, Japan, 241-8515
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Kumamoto City, Kumamoto, Japan, 860-8556
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Osaka, Japan, 540-0006
Korea, Republic of
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Suwon, Gyeonggi-do, Korea, Republic of, 443-721
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Seoul, Korea, Korea, Republic of, 110 744
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Seoul, Korea, Korea, Republic of, 120-752
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Seoul, Korea, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 137-701
Netherlands
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Dordrecht, Netherlands, 3318AT
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Nijmegen, Netherlands, 6525 GA
Peru
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Olsztyn, Poland, 10-513
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Russian Federation
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St.- Petersburg, Russia, Russian Federation, 197022
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St. Petersburg, Russian Federation, 197758
Singapore
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Slovakia
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South Africa
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Spain
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Tarragona, Cataluña, Spain, 43007
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Valencia, Comunidad Valenciana, Spain, 46010
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Valencia, Comunidad Valenciana, Spain, 46026
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Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, Spain, 35016
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Majadahonda, Madrid, Spain, 28222
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San Sebastian de los Reyes, Madrid, Spain, 28700
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El Palmar, Murcia, Spain, 30120
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Elche, Murcia, Spain, 03202
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Barcelona, Spain, 08025
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Madrid, Spain, 28009
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Madrid, Spain, 28033
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Madrid, Spain, 28040
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Madrid, Spain, 28046
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Madrid, Spain, 28050
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Zaragoza, Spain, 50009
Switzerland
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Bellinzona, Switzerland, 6500
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Genève, Switzerland, 1211
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Zuerich, Switzerland
Taiwan
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Kaohsiung, Taiwan, 807
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Kaohsiung, Taiwan, 833
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Taichung, Taiwan, 40447
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Taipei, Taiwan, 10048
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Taipei, Taiwan
Thailand
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10330
United Kingdom
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Truro, Cornwall, United Kingdom, TR1 3LJ
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Bournemouth, United Kingdom, BH7 7DW
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Derby, United Kingdom, DE22 3NE
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Leicester, United Kingdom, LE1 5WW
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Liverpool, United Kingdom, L7 8XP
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London, United Kingdom, SE1 9RT
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London, United Kingdom, WC1E 6HX
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Manchester, United Kingdom, M20 2BX
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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 7, 2015
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Aromatase Inhibitors
Estradiol
Fulvestrant
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2015