Breast Cancer Clinical Trial

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

Summary

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

View Full Description

Full Description

Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by PI3K pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on Response Evaluation Criteria In Solid Tumors [RECIST] version 1.1).

Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).

View Eligibility Criteria

Eligibility Criteria

Key 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

Key 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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1147

Study ID:

NCT01610284

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 257 Locations for this study

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University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)
Mobile Alabama, 36688, United States
Arizona Oncology Associates Dept of Oncology
Phoenix Arizona, , United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Shapiro and Stafford and Yee and Polanski Study Coordinator
Arcadia California, 91007, United States
Cancer Care Associates Dept.ofCancerCareAssoc.
Fresno California, 93720, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Fullerton California, 92835, United States
University of California San Diego - Moores Cancer Center UCSD 3
La Jolla California, 92093, United States
Los Angeles Hematology/Oncology Medical Group LA Cancer Network
Los Angeles California, 90017, United States
USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)
Los Angeles California, 90053, United States
University of California at Los Angeles Dept. of UCLA
Los Angeles California, 90095, United States
Ventura County Hematology and Oncology PMK Medical Group
Oxnard California, 93030, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93401, United States
Santa Barbara Hematolgy Oncology Medical Group
Santa Barbara California, 93105, United States
Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
St Joseph Heritage Healthcare Dept. of RRMG (4)
Santa Rosa California, 94503, United States
Granada Hills Cancer Center
Valencia California, 91355, United States
Kaiser Permanente Northwest Kaiser
Denver Colorado, , United States
Rocky Mountain Cancer Centers RMCC
Greenwood Village Colorado, , United States
Memorial Regional Cancer Center MRCC
Hollywood Florida, 33021, United States
Cancer Specialists of North Florida SC - F2302
Jacksonville Florida, 32258, United States
University of Miami Univ Miami 2
Miami Florida, 33136, United States
MD Anderson Cancer Center - Orlando MD Orlando
Orlando Florida, 32806, United States
Georgia Cancer Specialists SC
Decatur Georgia, 30033, United States
North Shore University Health System
Evanston Illinois, 60201, United States
Cadence Health
Geneva Illinois, 60134, United States
Cancer Care and Hematology Specialists of Chicagoland Niles
Multiple Locations Illinois, , United States
Cancer Center of Kansas CCK
Wichita Kansas, 67214, United States
Mercy Medical Center Mercy Medical SC
Baltimore Maryland, 21202, United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins
Baltimore Maryland, 21231, United States
Frederick Memorial Hospital Fred. Mem. Hosp.
Frederick Maryland, 21701, United States
Maryland Oncology Hematology, P.A. SC
Rockville Maryland, 20850, United States
Massachusetts General Hospital SC
Boston Massachusetts, 02114, United States
West Michigan Cancer Center Dept of Oncology
Kalamazoo Michigan, 49007, United States
Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint
Tupelo Mississippi, 38801, United States
Washington University School of Medicine Regulatory
Saint Louis Missouri, 63110, United States
Hackensack Meridian Health
Brick New Jersey, 08724, United States
The Valley Hospital / Luckow Pavillion
Paramus New Jersey, 07652, United States
Clinical Research Alliance SC-2
Lake Success New York, 11042, United States
Memorial Sloan Kettering Dept Onc
New York New York, 10017, United States
University of Rochester Medical Center Univ Rochester
Rochester New York, 14642, United States
Levine Cancer Institute Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Case Western Reserve SC
Cleveland Ohio, 44106, United States
Northwest Cancer Specialists Portland Loc
Portland Oregon, 97210, United States
St. Luke's Hospital and Health Network St Luke's (2)
Bethlehem Pennsylvania, 18015, United States
Charleston Hematology Oncology Association PA
Charleston South Carolina, 29414, United States
Tennessee Cancer Specialists
Knoxville Tennessee, 37909, United States
Vanderbilt University Medical Center Vanderbilt - Thompson Ln
Nashville Tennessee, 37232, United States
Texas Oncology P A Midtown
Dallas Texas, 75251, United States
Texas Oncology P A TX Onc - Bedford
Dallas Texas, 75251, United States
Texas Oncology P A TX Onc - Med City Dallas
Dallas Texas, 75251, United States
Texas Oncology P A TX Onc - Southwest
Dallas Texas, 75251, United States
Oncology Consultants Oncology Consultants, P.A.
Houston Texas, 77024, United States
Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development
San Antonio Texas, 78229, United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City Utah, 84106, United States
Oncology Hematology Associates of Southeast Virginia Salem VA Branch
Roanoke Virginia, 24014, United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
Kennewick Washington, 99336, United States
West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology
Morgantown West Virginia, 26506, United States
Cancer TEAM Bellin Health Belin Health
Green Bay Wisconsin, 54313, United States
Dean Health System Dean Hematology Oncology
Madison Wisconsin, 53717, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
Madison Wisconsin, 53792, United States
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Caba Buenos Aires, C1050, Argentina
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Mar del Plata Buenos Aires, B7600, Argentina
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San Miguel De Tucuman Tucuman, T4000, Argentina
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Rio Negro Viedma, 8500, Argentina
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Sydney New South Wales, 2060, Australia
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Woollongong New South Wales, 2500, Australia
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South Brisbane Queensland, 4101, Australia
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Clayton Victoria, 3168, Australia
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Melbourne Victoria, 3000, Australia
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Murdoch Western Australia, 6150, Australia
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Nedlands Western Australia, 6009, Australia
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Linz , 4010, Austria
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Salzburg , 5020, Austria
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Wien , A-109, Austria
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Jette Brussel, 1090, Belgium
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Bruxelles , 1000, Belgium
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Charleroi , 6000, Belgium
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Leuven , 3000, Belgium
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Liege , 4000, Belgium
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Namur , 5000, Belgium
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Wilrijk , 2610, Belgium
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Belo Horizonte MG, 30150, Brazil
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Curitiba PR, 81520, Brazil
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Natal RN, 59075, Brazil
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Ijuí RS, 98700, Brazil
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Barretos SP, 14784, Brazil
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Sao Paulo SP, 01246, Brazil
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Sorocaba SP, , Brazil
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Kelowna British Columbia, V1Y 5, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Cambridge Ontario, N1R 3, Canada
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London Ontario, N6A 4, Canada
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Newmarket Ontario, J7Y 2, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Laval Quebec, H7M 3, Canada
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Montreal Quebec, H2L 4, Canada
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Regina Saskatchewan, S4T 7, Canada
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Quebec , G1S 4, Canada
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Harbin Heilongjiang, 15008, China
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Changsha Hunan, 41001, China
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Nanjing Jiangsu, 21000, China
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Shengyang Liaoning, 11004, China
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Shanghai Shanghai, 20003, China
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Chengdu Sichuan, 61004, China
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Hangzhou Zhejiang, 31002, China
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Beijing , 10003, China
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Guangzhou , 51006, China
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Shanghai , 20002, China
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Brno Bohunice Czech Republic, 625 0, Czechia
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Olomouc CZE, 775 2, Czechia
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Brno , 65653, Czechia
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Nice Cedex 2 Alpes Maritimes, 06189, France
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Dijon Cedex Cote D Or, 21034, France
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Saint Priest en Jarez Loire, 42270, France
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Angers Cedex 02 , 49055, France
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Avignon Cedex , 84082, France
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Besancon cedex , 25030, France
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Bordeaux , 33076, France
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Caen Cedex , 14021, France
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Clermont-Ferrand , 63011, France
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Le Mans Cedex , 72015, France
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Lille Cedex , 59020, France
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Montpellier Cedex 5 , 34298, France
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Paris , 75010, France
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Paris , 75231, France
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Rouen Cedex 1 , 76038, France
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Saint-Herblain Cédex , 44805, France
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Strasbourg cedex , 67085, France
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Toulouse Cedex 9 , 31059, France
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Villejuif Cedex , 94800, France
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Langen Hessen, 63225, Germany
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Recklinghausen North Rhine-westphalia, 45657, Germany
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Luebeck Schleswig-holstein, 23563, Germany
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Essen , 45147, Germany
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Hamburg , 20249, Germany
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Hannover , 30177, Germany
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Heidelberg , 69120, Germany
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Kiel , 24105, Germany
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Magdeburg , 39108, Germany
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Mainz , 55131, Germany
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Mannheim , 68165, Germany
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Mühlhausen , 99974, Germany
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München , 80638, Germany
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Saarbruecken , 66113, Germany
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Velbert , 42551, Germany
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Wuerzburg , 97080, Germany
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Thessaloniki GR, 54645, Greece
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Athens , 115 2, Greece
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Heraklion Crete , 711 1, Greece
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Patras , 265 0, Greece
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Budapest , H 112, Hungary
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Debrecen , 4032, Hungary
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Miskolc , 3526, Hungary
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Szolnok , H-500, Hungary
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Haifa , 35254, Israel
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Jerusalem , 91120, Israel
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Petach Tikva , 49100, Israel
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Ramat Gan , 52621, Israel
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Tel Aviv , 64239, Israel
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Cuneo CN, 12100, Italy
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Cremona CR, 26100, Italy
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Catanzaro CZ, 88100, Italy
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Meldola FC, 47014, Italy
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Firenze FI, 50134, Italy
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Lido di Camaiore LU, 55041, Italy
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Macerata MC, 62100, Italy
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Milano MI, 20122, Italy
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Milano MI, 20133, Italy
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Milano MI, 20141, Italy
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Milano MI, 20162, Italy
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Rozzano MI, 20089, Italy
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Pisa PI, 56126, Italy
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Aviano PN, 33081, Italy
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Roma RM, 00128, Italy
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Roma RM, 00161, Italy
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Roma RM, 00189, Italy
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Rimini RN, 47900, Italy
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Torino TO, 10126, Italy
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Mirano VE, 30035, Italy
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Bologna , 40138, Italy
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Napoli , 80131, Italy
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Nagoya Aichi, 464 8, Japan
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Kashiwa Chiba, 277 8, Japan
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Fukuoka-city Fukuoka, 811-1, Japan
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Maebashi city Gunma, 371 8, Japan
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Sapporo-city Hokkaido, 003-0, Japan
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Isehara Kanagawa, 259-1, Japan
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Yokohama-city Kanagawa, 241-8, Japan
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Kumamoto City Kumamoto, 860-8, Japan
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Sakyo Ku Kyoto, 606 8, Japan
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Osaka-city Osaka, 540-0, Japan
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Osaka-city Osaka, 541-8, Japan
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Suita city Osaka, 565 0, Japan
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Koto ku Tokyo, 135 8, Japan
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Suwon Gyeonggi-do, 44338, Korea, Republic of
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Seoul Seocho Gu, 06591, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Nijmegen , 6500 , Netherlands
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Surquillo Lima, 34, Peru
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Kraków , , Poland
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Olsztyn , 10-51, Poland
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Warszawa , 02-77, Poland
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Moscow , 11547, Russian Federation
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Moscow , 11599, Russian Federation
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Nizhniy Novgorod , 60308, Russian Federation
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St Petersburg , 19775, Russian Federation
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St- Petersburg , 19702, Russian Federation
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Singapore , 16961, Singapore
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Bratislava Slovak Republic, 83310, Slovakia
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Kosice , 041 9, Slovakia
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Johannesburg , 2196, South Africa
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Parktown , 2193, South Africa
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Elche Alicante, 03203, Spain
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Cordoba Andalucia, 14004, Spain
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Jaen Andalucia, 23007, Spain
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Malaga Andalucia, 29010, Spain
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Sevilla Andalucia, 41009, Spain
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Sevilla Andalucia, 41013, Spain
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Sevilla Andalucia, 41014, Spain
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Oviedo Asturias, 33006, Spain
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Toledo Castilla La Mancha, 45071, Spain
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Barcelona Catalunya, 08003, Spain
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Barcelona Catalunya, 08035, Spain
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Barcelona Catalunya, 08036, Spain
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Barcelona Cataluña, 08024, Spain
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Tarragona Cataluña, 43007, Spain
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Valencia Comunidad Valenciana, 46009, Spain
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Valencia Comunidad Valenciana, 46010, Spain
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Valencia Comunidad Valenciana, 46026, Spain
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Las Palmas De Gran Canarias Las Palmas De Gran Canaria, 35016, Spain
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San Sebastian de los Reyes Madrid, 28702, Spain
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El Palmar Murcia, 30120, Spain
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Barcelona , 08041, Spain
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Madrid , 28009, Spain
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Madrid , 28033, Spain
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Madrid , 28040, Spain
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Madrid , 28046, Spain
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Madrid , 28050, Spain
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Madrid , 28222, Spain
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Zaragoza , 50009, Spain
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Bellinzona , 6500, Switzerland
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Genève , 1211, Switzerland
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Zuerich , 8038, Switzerland
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Kaohsiung , 80756, Taiwan
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Kaohsiung , 833, Taiwan
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Taichung , 40447, Taiwan
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Taipei , 10048, Taiwan
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Taipei , 112, Taiwan
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Bangkok , 10330, Thailand
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Bangkok , 10400, Thailand
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Bangkok , 10700, Thailand
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Truro Cornwall, TR1 3, United Kingdom
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Bournemouth , BH7 7, United Kingdom
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Derby , DE22 , United Kingdom
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Leicester , LE1 5, United Kingdom
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Liverpool , L7 8X, United Kingdom
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London , SE1 9, United Kingdom
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London , WC1E , United Kingdom
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Manchester , M20 2, United Kingdom
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Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1147

Study ID:

NCT01610284

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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