Spots Global Cancer Trial Database for Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
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Trial Identification
Brief Title: Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
Official Title: A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Study ID: NCT01506609
Conditions
Study Description
Brief Summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham - Main /ID# 62994, Birmingham, Alabama, United States
Banner MD Anderson Cancer Ctr /ID# 118695, Gilbert, Arizona, United States
University of Arkansas for Medical Sciences /ID# 60750, Little Rock, Arkansas, United States
Moore UC San Diego Cancer Center /ID# 60754, La Jolla, California, United States
The Angeles Clinic and Researc /ID# 60743, Los Angeles, California, United States
Stanford University School of Med /ID# 65488, Stanford, California, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 60760, West Hollywood, California, United States
Univ of Colorado Cancer Center /ID# 60751, Aurora, Colorado, United States
Lynn Cancer Institute, Boca /ID# 60749, Boca Raton, Florida, United States
Holy Cross Hospital /ID# 62995, Fort Lauderdale, Florida, United States
Moffitt Cancer Center /ID# 60746, Tampa, Florida, United States
Florida Cancer Specialists - East /ID# 60762, West Palm Beach, Florida, United States
University of Illinois - Chicago /ID# 106175, Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine /ID# 60755, Chicago, Illinois, United States
Rush University Medical Center /ID# 65489, Chicago, Illinois, United States
Midwestern Regional CTC /ID# 60744, Zion, Illinois, United States
Johns Hopkins University /ID# 60759, Baltimore, Maryland, United States
Massachusetts General Hospital /ID# 64582, Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 93833, Boston, Massachusetts, United States
William Beaumont Hospital /ID# 95417, Royal Oak, Michigan, United States
Washington University-School of Medicine /ID# 62724, Saint Louis, Missouri, United States
Beth Israel Medical Center /ID# 87993, New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222, New York, New York, United States
Duke University Medical Center /ID# 60747, Durham, North Carolina, United States
Penn State University and Milton S. Hershey Medical Center /ID# 62723, Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 60753, Philadelphia, Pennsylvania, United States
University of Pittsburgh MC /ID# 60758, Pittsburgh, Pennsylvania, United States
University of Pittsburgh MC /ID# 65486, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina /ID# 60752, Charleston, South Carolina, United States
The West Clinic /ID# 65487, Memphis, Tennessee, United States
The West Clinic /ID# 94599, Memphis, Tennessee, United States
The West Clinic /ID# 94600, Memphis, Tennessee, United States
UT Southwestern Medical Center /ID# 60745, Dallas, Texas, United States
Houston Methodist Hospital - Scurlock Tower /ID# 60742, Houston, Texas, United States
Coiba /Id# 65219, Berazategui, Buenos Aires, , Argentina
ISIS Centro Especializado /ID# 65226, Santa Fe, , Argentina
The Prince of Wales Hospital /ID# 63271, Randwick, New South Wales, Australia
Southern Medical Day Care Ctr /ID# 63274, Wollongong, New South Wales, Australia
Mater Misericordiae Limited /ID# 63276, South Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 63280, Adelaide, South Australia, Australia
Royal Hobart Hospital /ID# 63279, Hobart, Tasmania, Australia
Peter MacCallum Cancer Ctr /ID# 63272, Melbourne, Victoria, Australia
Royal Melbourne Hospital /ID# 63278, Parkville, Victoria, Australia
Mount Hospital /ID# 65262, Perth, Western Australia, Australia
Cliniques Universitaires Saint Luc /ID# 96135, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Grand Hôpital de Charleroi /ID# 96136, Charleroi, Hainaut, Belgium
AZ St-Jan Brugge-Oostende AV /ID# 107315, Brugge, West-Vlaanderen, Belgium
UZ Antwerp /ID# 96945, Edegem, , Belgium
UZ Leuven /ID# 96138, Leuven, , Belgium
CHU UCL Namur /ID# 110595, Namur, , Belgium
Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247, Lajeado, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de /ID# 65244, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre /ID# 65242, Porto Alegre, Rio Grande Do Sul, Brazil
Sunnybrook Health Sciences Ctr /ID# 77373, Toronto, Ontario, Canada
Jewish General Hospital /ID# 69893, Montreal, Quebec, Canada
CHUM - Notre-Dame Hospital /ID# 67862, Montréal, Quebec, Canada
CHUQ-Hospital St. Sacrement /ID# 68902, Quebec City, Quebec, Canada
Masarykuv onkologicky ustav /ID# 65170, Brno, , Czechia
Palacky University /ID# 63923, Olomouc, , Czechia
Vseobecna Fakultni Nemocnice /ID# 65172, Prague, , Czechia
Vejle Sygehus /ID# 65173, Vejle, Syddanmark, Denmark
Rigshospitalet, Finsen Centre /ID# 67822, Copenhagen, , Denmark
Docrates Cancer Center /ID# 63924, Helsinki, , Finland
Tampere University Hospital /ID# 102417, Tampere, , Finland
Hopital Universitaire Purpan /ID# 98815, Toulouse, Haute-Garonne, France
Institut Curie /ID# 63926, Paris CEDEX 05, Ile-de-France, France
Institut de Cancer de l'Ouest /ID# 63927, St Herblain CEDEX, Loire-Atlantique, France
Centre Leon Berard /ID# 106675, Lyon CEDEX 08, Rhone, France
Pays-Basque Ctr Oncology/Radio /ID# 65176, Bayonne, , France
Institut Paoli-Calmettes /ID# 65175, Marseille, , France
Hopital Rene Huguenin /ID# 65177, Saint-cloud, , France
Centre Paul Strauss /ID# 100275, Strasbourg, , France
Bajcsy-Zsilinszky Korhaz /ID# 65179, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 65178, Debrecen, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928, Szolnok, , Hungary
Rabin Medical Center /ID# 63929, Petakh Tikva, Tel-Aviv, Israel
Soroka University Medical Center /ID# 65180, Be'er Sheva, , Israel
Assaf Harofeh Medical Center /ID# 65181, Be'er Ya'akov, , Israel
Rambam Health Care Campus /ID# 63930, Haifa, , Israel
Shaare Zedek Medical Center /ID# 116575, Jerusalem, , Israel
Gastroenterology Institute, Division of Medicine /ID# 63931, Jerusalem, , Israel
Sheba Medical Center /ID# 63932, Ramat Gan, , Israel
Kaplan Medical Center /ID# 63933, Rehovot, , Israel
Erasmus Medisch Centrum /ID# 96275, Rotterdam, , Netherlands
Haukeland University Hospital /ID# 67982, Bergen, Hordaland, Norway
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975, Rzeszów, Podkarpackie, Poland
Centrum Onkologii Lukaszczyka /ID# 73393, Bydgoszcz, , Poland
Olsztynski Osrodek Onkologi /ID# 71060, Olsztyn, , Poland
NZOZ Centrum Medyczne HCP /ID# 68102, Poznan, , Poland
Wielkopolskie Centrum Onkologi /ID# 71061, Poznan, , Poland
S.C. lanuli Med Consult SRL /ID# 106955, Bucharest, , Romania
lnstitutul Oncologic Trestiore /ID# 96742, Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta /ID# 96741, Cluj, , Romania
Inst Oncology Prof. Chiricuta /ID# 96740, Cluj, , Romania
Sc Oncolab Srl /Id# 96745, Craiova, , Romania
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263, Moscow, Moskva, Russian Federation
Chelyabinsk Reg Clin Oncology /ID# 63938, Chelyabinsk, , Russian Federation
State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415, Murmansk, , Russian Federation
City Clinical Hospital 1 /ID# 102416, Novosibirsk, , Russian Federation
Pyatigorsk Oncology Dispensary /ID# 65264, Pyatigorsk, , Russian Federation
Birch A Healthcare /ID# 65265, St. Petersburg, , Russian Federation
N.N. Petrov Research Inst Onc /ID# 65269, St. Petersburg, , Russian Federation
N.N. Petrov Research Inst Onc /ID# 78973, St. Petersburg, , Russian Federation
Volgograd Reg Onc Disp #3 /ID# 98035, Volzhsky, , Russian Federation
Hospital Universitario Vall d'Hebron /ID# 97415, Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 97418, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 97417, Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 97416, Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 97976, Malaga, , Spain
Hospital Clinico Universitario de Valencia /ID# 97975, Valencia, , Spain
Skanes Universitetssjukhus /ID# 96475, Malmö, Skane Lan, Sweden
Sahlgrenska University Hosp /ID# 97715, Goteborg, , Sweden
Karolinska Univ Sjukhuset /ID# 98037, Solna, , Sweden
Cherkassy Regional Onc Ctr /ID# 97698, Cherkasy, , Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940, Dnipro, , Ukraine
Communal non-profit enterprise Regional Center of Oncology /ID# 97696, Kharkiv, , Ukraine
Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941, Lviv, , Ukraine
Odessa National Medical Univ /ID# 65278, Odesa, , Ukraine
Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697, Poltava, , Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280, Sumy, , Ukraine
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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