Breast Cancer Clinical Trial

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

Summary

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC
Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: patients must have measurable disease
Participant has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant has received no more than one line of therapy for metastatic disease.
Participant has adequate bone marrow and organ function

Exclusion Criteria:

Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients
Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia
Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening
Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c
Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion
Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis
Participant has currently documented pneumonitis/interstitial lung disease
Participant has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS)
Participant with unresolved osteonecrosis of the jaw

Other protocol-defined inclusion/exclusion criteria apply.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

566

Study ID:

NCT04251533

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 216 Locations for this study

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Mayo Clinic Arizona
Phoenix Arizona, 85054, United States More Info
Jessica McKeowen
Contact
480-342-2545
[email protected]
Donald W Northfelt
Principal Investigator
Comprehensive Blood and Cancer Center Dept. of CBCC (2)
Bakersfield California, 93309, United States More Info
Nicole Ward
Contact
661-862-7158
[email protected]
David Kanamori
Principal Investigator
Cancer and Blood Specialty Clinic
Los Alamitos California, 90720, United States More Info
Contact
562-735-0602
Vu Phan
Principal Investigator
USC Norris Cancer Center
Los Angeles California, 90033, United States More Info
Sophie Miehl
Contact
323-865-3955
[email protected]
Janice Lu
Principal Investigator
UCLA Medical Center Santa Monica Location
Los Angeles California, 90095, United States More Info
Glaucia Vasquez
Contact
+1 310 582 4069
[email protected]
Sara Alsterlind Hurvitz
Principal Investigator
Cancer Care Associates Medical Group Center
Redondo Beach California, 90277, United States More Info
David Chan
Principal Investigator
Florida Cancer Specialists Dept of Oncology (2)
Fort Myers Florida, 33901, United States More Info
Michele Hartzer
Contact
727-216-1143
[email protected]
Sunil Gandhi
Principal Investigator
Florida Cancer Specialists FL Cancer Specialists
Fort Myers Florida, 33901, United States More Info
Deaneda Gerhart
Contact
[email protected]
Faithlore P Gardner
Principal Investigator
Florida Cancer Specialists Onc Dept
Fort Myers Florida, 33901, United States More Info
Jenifer Bar-Nur
Contact
561-472-1596
[email protected]
Elizabeth Byron
Principal Investigator
Florida Cancer Affiliates of Ocala
Ocala Florida, 34471, United States More Info
Sanjit Nirmalanandhan
Contact
[email protected]
Rama Balaraman
Principal Investigator
University of Illinois Cancer Center at Chicago
Chicago Illinois, 60612, United States
Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd
Fort Wayne Indiana, 46815, United States
University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2
Kansas City Kansas, 66160, United States More Info
Jecinta Scott
Contact
913-588-2566
[email protected]
Priyanka Sharma
Principal Investigator
Hematology and Oncology Clinic SC
Baton Rouge Louisiana, 70809, United States More Info
Aimee Alumbaugh
Contact
[email protected]
Michael Castine III
Principal Investigator
Sinai Hospital of Baltimore Dept of Sinai Hospital - 2
Baltimore Maryland, 21215, United States More Info
Phyllis Bull
Contact
410-601-0960
Mayer Gorbaty
Principal Investigator
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Francesca Picotte
Contact
313-916-1984
[email protected]
Vrushali Dabak
Principal Investigator
Mayo Clinic Rochester Mayo - Roch.
Rochester Minnesota, 55905, United States More Info
Matthew Goetz
Contact
507-266-0539
[email protected]
Roberto Leon Ferre
Principal Investigator
Park Nicollet Institute Dept Onc
Saint Louis Park Minnesota, 55416, United States More Info
Joanna Hill
Contact
952-993-5710
[email protected]
Dylan Zylla
Principal Investigator
Research Medical Center HCA Midwest Division
Kansas City Missouri, 64132, United States
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
Henderson Nevada, 89052, United States
Renown Healthcare Systems
Reno Nevada, 89502, United States More Info
Lisa Lionetti Freutel
Contact
775-982-2951
[email protected]
Lee Schwartzberg
Principal Investigator
Meridian Health Systems
Neptune New Jersey, 07753, United States More Info
Roxanne Valasa
Contact
609-597-6011
[email protected]
Evan Naylor
Principal Investigator
New York Oncology Hematology, P.C.
Albany New York, 12206, United States
Cleveland Clinic Foundation Taussig Cancer Center
Cleveland Ohio, 44195, United States More Info
Holly Sasak
Contact
216-444-6833
[email protected]
Megan Kruse
Principal Investigator
University of Pittsburgh Cancer Institute Cancer Pavilion, 5th floor
Pittsburgh Pennsylvania, 15232, United States More Info
Adam Brufsky
Principal Investigator
Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States More Info
Kim Tucker
Contact
423-698-1844
[email protected]
Brooke Daniel
Principal Investigator
Tennessee Oncology Tennessee Oncology (3)
Nashville Tennessee, 37203, United States More Info
Lillie Flynn
Contact
615-329-7664
[email protected]
Denise A Yardley
Principal Investigator
Texas Oncology, P.A. Austin
Bedford Texas, 76022, United States More Info
Patricia Janeczko
Contact
512-421-4163
[email protected]
Debra A Patt
Principal Investigator
Texas Oncology PA Dallas Presbyterian Hospital SC
Dallas Texas, 75231, United States More Info
Carly Trainor
Contact
214-265-2080
[email protected]
Kristi J McIntyre
Principal Investigator
Texas Oncology Texas Oncology - Denton
Dallas Texas, 75246, United States More Info
Nieves Contreras Alcantera
Contact
+1 940 382 1022
[email protected]
Charles Kurkul
Principal Investigator
US Oncology US Oncology Associates
Dallas Texas, 75246, United States More Info
Syed Hasan
Contact
703-554-6801
[email protected]
Alina Huang
Principal Investigator
El Paso, Texas Oncology
El Paso Texas, 79902, United States More Info
Nicole Dean
Contact
[email protected]
Ines Sanchez-Rivera
Principal Investigator
Texas Oncology Houston Memorial City SC
Houston Texas, 77024, United States More Info
Nina Fru
Contact
[email protected]
Michelina Cairo
Principal Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jennifer Childress
Contact
713-792-2921
[email protected]
Debasish Tripathy
Principal Investigator
Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio
San Antonio Texas, 78229, United States More Info
Christine Korn
Contact
210-424-2610
[email protected]
Emmalind T Aponte
Principal Investigator
Texas Oncology Northeast Texas
Tyler Texas, 75702, United States More Info
Penny Watkins
Contact
903-579-9867
[email protected]
Sasha Strain
Principal Investigator
Virginia Oncology Associates
Norfolk Virginia, 23502, United States More Info
Evangeline Charity
Contact
757-873-9833
[email protected]
Michael A. Danso
Principal Investigator
Northwest Medical Specialties Northwest Medical - Puyallup
Tacoma Washington, 98405, United States More Info
Emily Kerry
Contact
253-620-4234
[email protected]
Sibel Blau
Principal Investigator
Novartis Investigative Site
Caba Buenos Aires, C1125, Argentina
Novartis Investigative Site
Caba Buenos Aires, C1280, Argentina
Novartis Investigative Site
Caba Buenos Aires, C1426, Argentina
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Buenos Aires Caba, C1431, Argentina
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Rosario Santa Fe, S2000, Argentina
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Rio Negro Viedma, 8500, Argentina
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Darlinghurst New South Wales, 2010, 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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Innsbruck Tyrol, 6020, Austria
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Leoben , A 870, Austria
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Salzburg , 5020, Austria
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Vienna , 1090, Austria
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Vienna , A-109, Austria
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Caxias do Sul RS, 95070, Brazil
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Barretos SP, 14784, Brazil
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Sao Paulo SP, 01317, Brazil
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Sao Paulo SP, 04014, Brazil
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Plovdiv , 4004, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1756, Bulgaria
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Varna , 9010, Bulgaria
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Hefei Anhui, 23000, China
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Chongqing Chongqing, 40410, China
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Guangzhou Guangdong, 51063, China
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Guiyang Guizhou, 55000, China
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Shijiazhuang Hebei, 05001, China
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Harbin Heilongjiang, 15008, China
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Wuhan Hubei, 43002, China
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Changsha Hunan, 41001, China
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Nanjing Jiangsu, 21002, China
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Nanchang Jiangxi, 33000, China
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Chang Chun Jilin, 13002, China
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Shengyang Liaoning, 11004, China
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Jinan Shandong, 25011, China
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Xian Shanxi, 71006, China
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Chengdu Sichuan, 61004, China
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Tianjin Tianjin, 30006, China
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Hangzhou Zhejiang, 31001, China
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Hangzhou Zhejiang, 31002, China
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Beijing , 10002, China
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Dalian , , China
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Qingdao , 26600, China
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Shanghai , 20002, China
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Shenyang , 11000, China
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Rionegro Antioquia, 05404, Colombia
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Ibague Tolima, 73000, Colombia
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Bogota , 11022, Colombia
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Bogota , 11023, Colombia
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Split HRV, 21000, Croatia
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Zagreb , 10000, Croatia
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Saint-Cloud Hauts De Seine, 92210, France
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Angers Cedex 02 , 49055, France
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Besancon Cedex , 25030, France
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Bordeaux , 33076, France
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Clermont Ferrand , 63011, France
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Creteil , 94010, France
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Dijon , 21034, France
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Le Mans , 72000, France
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Metz , 57085, France
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Nimes Cedex 9 , 30029, France
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Paris Cedex 10 , 75475, France
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Poitiers , 86000, France
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Reims , 51100, France
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Saint-Herblain Cédex , 44805, France
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Villejuif Cedex , 94800, France
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Ravensburg Baden-Wuerttemberg, 88212, Germany
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Muenchen Bavaria, 80637, Germany
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Essen Nordrhein-Westfalen, 45136, Germany
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Velbert North Rhine-westphalia, 42551, Germany
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Luebeck Schleswig-holstein, 23563, Germany
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Berlin , 13581, Germany
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Bonn , 53111, Germany
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Dresden , 01307, Germany
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Erlangen , 91054, Germany
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Hamburg , 20357, Germany
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Heidelberg , 69120, Germany
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Leipzig , 04103, Germany
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Mannheim , 68167, Germany
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Rostock , 18059, Germany
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Tübingen , 72076, Germany
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Ulm , 89081, Germany
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Wuerzburg , 97080, Germany
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Hong Kong , , Hong Kong
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Budapest , 1062, Hungary
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Budapest , H 112, Hungary
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Debrecen , 4032, Hungary
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Kecskemet , 6000, Hungary
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Tatabanya , H 280, Hungary
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Faridabad Haryana, 121 0, India
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Mumbai Maharashtra, 400 0, India
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Mumbai Maharashtra, 40005, India
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Vellore Tamil Nadu, 632 0, India
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Hyderabad Telangana, 50003, India
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Hyderabad Telangana, 50008, India
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Kolkata West Bengal, 70016, India
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Be'er Sheva , 84571, Israel
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Jerusalem , 91120, Israel
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Ramat Gan , 52621, Israel
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Tel Aviv , 64239, Israel
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Ancona AN, 60126, Italy
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Brindisi BR, 72100, Italy
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Meldola FC, 47014, Italy
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Genova GE, 16132, Italy
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Monza MB, 20900, Italy
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Messina ME, 98158, Italy
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Rionero in Vulture PZ, 85028, Italy
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Roma RM, 00128, Italy
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Roma RM, 00168, Italy
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Torino TO, 10126, Italy
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Napoli , 80131, Italy
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Amman , 11941, Jordan
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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El Chouf LBN, 15032, Lebanon
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Ashrafieh , 16683, Lebanon
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Beirut , 1107 , Lebanon
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Petaling Jaya Selangor, 46050, Malaysia
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Kuala Lumpur , 59100, Malaysia
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Pulau Pinang , 10990, Malaysia
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Tuxtla Gutierrez Chiapas, 29038, Mexico
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Ciudad De Mexico Distrito Federal, 04980, Mexico
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Monterrey Nuevo Leon, 64460, Mexico
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Oslo , NO 04, Norway
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Stavanger , 4019, Norway
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Tromsoe , 9038, Norway
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Trujillo La Libertad, , Peru
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Lima , 33, Peru
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Lima , Lima , Peru
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Gdynia , 81 51, Poland
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Opole , 45-06, Poland
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Poznan , 61 48, Poland
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Rzeszow , 35-02, Poland
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Bucharest , 02232, Romania
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Cluj Napoca , 40000, Romania
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Cluj-Napoca , 40012, Romania
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Constanta , 90059, Romania
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Craiova , 20034, Romania
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Ploiesti , 10033, Romania
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Arkhangelsk , 16304, Russian Federation
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Chelyabinsk , 45404, Russian Federation
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Moscow , 11799, Russian Federation
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Moscow , 12305, Russian Federation
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Moscow , 14342, Russian Federation
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Pushkin Saint Petersburg , 19660, Russian Federation
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Belgrade , 11000, Serbia
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Nis , 18000, Serbia
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Bratislava Slovak Republic, 83310, Slovakia
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Bratislava , 812 5, Slovakia
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Kosice , 041 9, Slovakia
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Ljubljana , 1000, Slovenia
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Port Elizabeth Western Cape, 6045, South Africa
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Johannesburg , 2196, South Africa
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Pretoria , 0081, South Africa
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Almeria Andalucia, 04009, Spain
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Sabadell Barcelona, 08208, Spain
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Barcelona Catalunya, 08036, Spain
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Alicante Comunidad Valenciana, 03010, Spain
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Valencia Comunidad Valenciana, 46017, Spain
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Badajoz Extremadura, 06080, Spain
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Palma De Mallorca Islas Baleares, 07120, Spain
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Ferrol , 15405, Spain
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Madrid , 28009, Spain
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Madrid , 28041, Spain
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Santa Cruz de Tenerife , 38009, Spain
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Valencia , 46026, Spain
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Aarau , 5000, Switzerland
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Bern , 3010, Switzerland
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Lausanne , 1011, Switzerland
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Zurich , 8008, Switzerland
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Kaoshiung , 83301, Taiwan
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Taichung , 40447, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 10449, Taiwan
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Taoyuan , 33305, Taiwan
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Adana , 01250, Turkey
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Ankara , 06100, Turkey
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Istanbul , 34722, Turkey
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Istanbul , 35100, Turkey
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Izmir , 35040, Turkey
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Talas / Kayseri , 38039, Turkey
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Nottingham , NG5 1, United Kingdom
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Oxford , OX3 7, United Kingdom
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Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

566

Study ID:

NCT04251533

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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