Spots Global Cancer Trial Database for A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
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Trial Identification
Brief Title: A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
Official Title: A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
Study ID: NCT02163694
Conditions
Study Description
Brief Summary: The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.
Detailed Description: This is a Phase 3, randomized, double-blind, multinational, multicenter study to evaluate the efficacy and tolerability of veliparib in combination with C/P compared to placebo in combination with C/P in participants with a BRCA1 or BRCA2 mutation, as documented by the Sponsor core laboratory, with HER2-negative metastatic or locally advanced unresectable breast cancer who received no more than 2 prior lines of cytotoxic therapy for metastatic disease. For the purposes of eligibility, HER2-negative status was based on the most recent tumor biopsy. Participants were randomized in a 2:1 ratio, with a total of approximately 500 participants planned to be randomized. Veliparib 120 mg/placebo twice a day (BID) was dosed Days -2 through 5 with carboplatin target area under the concentration-time curve (AUC) 6 administered on Day 1 and paclitaxel 80 mg/m2 administered weekly on Days 1, 8, and 15 of each 21-day cycle. Safety and efficacy data through the prespecified primary analysis cutoff date of 05 April 2019 are included in the interim analysis.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Ctr /ID# 125011, Gilbert, Arizona, United States
University of Arkansas for Medical Sciences /ID# 124992, Little Rock, Arkansas, United States
City of Hope /ID# 127117, Duarte, California, United States
California Cancer Associates for Research & Excellence (cCARE) /ID# 136078, Fresno, California, United States
Moores Cancer Center at UC San Diego /ID# 124991, La Jolla, California, United States
Hematology and Oncology Assoc /ID# 130058, Newport Beach, California, United States
Cancer Research Collaboration /ID# 128860, Santa Ana, California, United States
Icri /Id# 128520, Whittier, California, United States
Univ of Colorado Cancer Center /ID# 124983, Aurora, Colorado, United States
Saint Joseph Hospital /ID# 131768, Denver, Colorado, United States
Norwalk Hospital /ID# 133509, Norwalk, Connecticut, United States
Lynn Cancer Institute, Boca /ID# 125013, Boca Raton, Florida, United States
Holy Cross Hospital /ID# 125012, Fort Lauderdale, Florida, United States
Sacred Heart Hospital /ID# 128279, Pensacola, Florida, United States
Moffitt Cancer Center /ID# 124990, Tampa, Florida, United States
Florida Cancer Specialists - East /ID# 125007, West Palm Beach, Florida, United States
Emory Midtown Infectious Disease Clinic /ID# 133192, Atlanta, Georgia, United States
The Cancer Ctr at DeKalb Med C /ID# 125024, Decatur, Georgia, United States
University of Illinois - Chicago /ID# 127576, Chicago, Illinois, United States
NorthShore University HealthSystem /ID# 124996, Evanston, Illinois, United States
Midwestern Regional CTC /ID# 124986, Zion, Illinois, United States
McFarland Clinic, PC /ID# 129904, Ames, Iowa, United States
Johns Hopkins University /ID# 125015, Baltimore, Maryland, United States
Baystate Medical Center /ID# 139461, Springfield, Massachusetts, United States
UMass Chan Medical School /ID# 129067, Worcester, Massachusetts, United States
Henry Ford Health System /ID# 134497, Detroit, Michigan, United States
Spectrum Health Medical Group /ID# 133568, Grand Rapids, Michigan, United States
Spectrum Health Medical Group /ID# 148471, Grand Rapids, Michigan, United States
William Beaumont Hospital /ID# 125019, Royal Oak, Michigan, United States
Univ of Mississippi Med Ctr,US /ID# 131352, Jackson, Mississippi, United States
St. Lukes Cancer Institute /ID# 125023, Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 127575, Saint Louis, Missouri, United States
Nebraska Hematology Oncology /ID# 132711, Lincoln, Nebraska, United States
Rutgers Cancer Institute of New Jersey /ID# 125017, New Brunswick, New Jersey, United States
University of New Mexico /ID# 125349, Albuquerque, New Mexico, United States
Beth Israel Medical Center /ID# 125001, New York, New York, United States
Mount Sinai St. Luke's /ID# 125003, New York, New York, United States
Mission Cancer Center /ID# 134248, Asheville, North Carolina, United States
Duke Cancer Center /ID# 124999, Durham, North Carolina, United States
The Ohio State University /ID# 125022, Columbus, Ohio, United States
University of Toledo /ID# 134849, Toledo, Ohio, United States
Oregon Health and Science University /ID# 134229, Portland, Oregon, United States
Lehigh Valley Health Network /ID# 130059, Allentown, Pennsylvania, United States
Lehigh Valley Hosp/Muhlenberg /ID# 130277, Bethlehem, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 124997, Hershey, Pennsylvania, United States
Allegheny General Hospital /ID# 135094, Pittsburgh, Pennsylvania, United States
University of Pittsburgh MC /ID# 125005, Pittsburgh, Pennsylvania, United States
Texas Health Physicians Group /ID# 137740, Arlington, Texas, United States
University of Texas Southwestern Medical Center /ID# 124989, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center /ID# 125353, Houston, Texas, United States
University of Vermont Medical Center /ID# 125350, Burlington, Vermont, United States
Swedish Cancer Institute - Issaquah /ID# 131534, Issaquah, Washington, United States
Swedish Cancer Institute - Edmonds /ID# 131549, Seattle, Washington, United States
Swedish Medical Center /ID# 125021, Seattle, Washington, United States
Swedish Cancer Insititute - Ballard /ID# 131548, Seattle, Washington, United States
Northwest Medical Specialties - Tacoma /ID# 125344, Tacoma, Washington, United States
COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839, Berazategui, Buenos Aires, Argentina
Clinica Pergamino /ID# 127158, Pergamino, Buenos Aires, Argentina
Instituto de Oncoloia de Rosario /ID# 127157, Rosario, Santa Fe, Argentina
Centro Oncologico Riojano Integral /ID# 127938, La Rioja, , Argentina
St George Hospital /ID# 129416, Kogarah, New South Wales, Australia
Duplicate_The Prince of Wales Hospital /ID# 124845, Randwick, New South Wales, Australia
Southern Medical Day Care Centre /ID# 124844, Wollongong, New South Wales, Australia
Townsville University Hospital /ID# 126731, Douglas, Queensland, Australia
Duplicate_Flinders Centre for Innovation /ID# 127535, Bedford Park, South Australia, Australia
Royal Hobart Hospital /ID# 124849, Hobart, Tasmania, Australia
The Royal Melbourne Hospital /ID# 124846, Parkville, Victoria, Australia
Hollywood Private Hospital /ID# 124843, Nedlands, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 126185, Linz, Oberoesterreich, Austria
Medizinische Universitaet Graz /ID# 126450, Graz, Steiermark, Austria
Medizinische Universitaet Wien /ID# 126184, Vienna, Wien, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449, Salzburg, , Austria
Bobruysk Interdistrict Onco. /ID# 137729, Bobruisk, , Belarus
State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223, Minsk, , Belarus
Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728, Mogilev, , Belarus
Vitebsk Regional Clinical Oncology Dispensary /ID# 125219, Vitebsk, , Belarus
Universitair Ziekenhuis Antwerpen /ID# 124977, Edegem, Antwerpen, Belgium
UCL Saint-Luc /ID# 124976, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Grand Hôpital de Charleroi /ID# 124981, Charleroi, Hainaut, Belgium
Universitair Ziekenhuis Leuven /ID# 124980, Leuven, Vlaams-Brabant, Belgium
Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975, Brugge, West-Vlaanderen, Belgium
ZNA Middelheim /ID# 124978, Antwerp, , Belgium
CHU UCL Namur - Sainte Elisabeth /ID# 124979, Namur, , Belgium
Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882, Toronto, Ontario, Canada
Duplicate_Jewish General Hospital /ID# 124880, Montreal, Quebec, Canada
CHUM - Notre-Dame Hospital /ID# 124879, Montréal, Quebec, Canada
Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881, Quebec City, Quebec, Canada
Hospital Clinico Vina del Mar /ID# 130100, Vina Del Mar, Valparaíso, Chile
Hospital Clinico Vina del Mar /ID# 148502, Vina Del Mar, Valparaíso, Chile
Instituto Nacional del Cancer /ID# 129343, Santiago, , Chile
ICOS - Inst Clinic Oncology /ID# 125236, Temuco, , Chile
Hospital Pablo Tobon Uribe /ID# 126657, Medellín, Antioquia, Colombia
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211, Monteria, Cordoba, Colombia
Administradora del Country_S.A-Clinica Del Country /ID# 125255, Bogota, Cundinamarca, Colombia
Hospital Univ San Ignacio /ID# 126655, Bogota, Cundinamarca, Colombia
Centro Medico Imbanaco de Cali /ID# 126656, Cali, , Colombia
Fakultni Nemocnice Brno /ID# 128176, Brno, , Czechia
Masarykuv onkologicky ustav /ID# 124886, Brno, , Czechia
Duplicate_FN Hradec Kralove /ID# 127080, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc /ID# 124885, Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze /ID# 124887, Praha, , Czechia
Rigshospitalet /ID# 124891, Copenhagen Ø, Hovedstaden, Denmark
Sygehus Lillebælt, Vejle /ID# 124892, Vejle, Syddanmark, Denmark
East Tallinn Central Hospital /ID# 126475, Kesklinna Linnaosa, Harjumaa, Estonia
Docrates Cancer Center /ID# 124896, Helsinki, , Finland
Duplicate_Helsinki Univ Central Hospital /ID# 124897, Helsinki, , Finland
Duplicate_Tampere University Hospital /ID# 124898, Tampere, , Finland
Vaasa Central Hospital /ID# 132548, Vaasa, , Finland
Institut Paoli-Calmettes /ID# 124903, Marseille, Bouches-du-Rhone, France
Institut Curie /ID# 124902, Paris CEDEX 05, Ile-de-France, France
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726, St Herblain CEDEX, Loire-Atlantique, France
Institut Curie - site CLCC René Huguenin /ID# 124904, Saint-cloud, , France
Universitaetsklinik Heidelberg /ID# 126664, Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinimum Tuebingen /ID# 129968, Tubingen, Baden-Wuerttemberg, Germany
Universitaetsklinikum Ulm /ID# 135230, Ulm, Baden-Wuerttemberg, Germany
Universitaetsklinikum Koeln /ID# 126905, Köln, Nordrhein-Westfalen, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180, Dresden, , Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256, Munich, , Germany
Sana Klinikum Offenbach /ID# 126733, Offenbach am Main, , Germany
Semmelweis Egyetem /ID# 132485, Budapest, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259, Pecs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911, Szolnok, , Hungary
Duplicate_Zala Megyei Korhaz /ID# 131341, Zalaegerszeg, , Hungary
The Chaim Sheba Medical Center /ID# 124918, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 130276, Tel Aviv-Yafo, Tel-Aviv, Israel
Duplicate_Soroka University Medical Center /ID# 124917, Be'er Sheva, , Israel
Assaf Harofeh Medical Center /ID# 124915, Be'Er Ya'Akov, , Israel
Rambam Health Care Campus /ID# 124916, Haifa, , Israel
Shaare Zedek Medical Center /ID# 130275, Jerusalem, , Israel
Gastroenterology Institute, Division of Medicine /ID# 124919, Jerusalem, , Israel
Kaplan Medical Center /ID# 124914, Rehovot, , Israel
Ospedale San Raffaele IRCCS /ID# 125261, Milan, Lombardia, Italy
IEO -Istituto Europeo di Oncologia /ID# 125260, Milan, Milano, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262, Negrar, Verona, Italy
Centro di Riferimento Oncologico /ID# 126738, Aviano, , Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263, Reggio Calabria, , Italy
National Cancer Center /ID# 125602, Goyang, Gyeonggido, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 125599, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Anam Hospital /ID# 128968, Seoul, , Korea, Republic of
Seoul National University Hospital /ID# 125600, Seoul, , Korea, Republic of
Asan Medical Center /ID# 125601, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 125598, Seoul, , Korea, Republic of
Pauls Stradins Clinical University Hospital /ID# 125264, Riga, , Latvia
Riga East Clinical University Hospital /ID# 125265, Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266, Kaunas, , Lithuania
National Cancer Institute /ID# 125267, Vilnius, , Lithuania
Centro de Estudios Clínicos Especializados /ID# 128680, Mérida, Yucatan, Mexico
Centro Oncologico de Chihuahua /ID# 128679, Chihuahua, , Mexico
Instituto Nacional de Cancerología INCAN /ID# 128676, Ciudad de Mexico, , Mexico
Erasmus Medisch Centrum /ID# 124935, Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 129069, Groningen, , Netherlands
Maastricht Universitair Medisch Centrum /ID# 129068, Maastricht, , Netherlands
Haukeland University Hospital /ID# 150177, Bergen, Hordaland, Norway
Wojewodzki Szpital Specjalistyczny /ID# 127258, Wroclaw, Dolnoslaskie, Poland
Centrum Onkologii Lukaszczyka /ID# 124938, Bydgoszcz, Kujawsko-pomorskie, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999, Lodz, Lodzkie, Poland
MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939, Rzeszow, Podkarpackie, Poland
Wojewodzki Szpital Zespolony /ID# 126998, Elblag, Warminsko-mazurskie, Poland
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510, Vila Nova De Gaia, Porto, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298, Faro, , Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299, Lisboa, , Portugal
Unidade Local de Saúde de Matosinhos, EPE /ID# 126511, Matosinhos, , Portugal
IPO Porto FG, EPE /ID# 125297, Porto, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508, Porto, , Portugal
Ad-Vance Medical Research, LLC /ID# 126043, Ponce, , Puerto Rico
San Juan Municipal Hospital /ID# 124695, San Juan, , Puerto Rico
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948, Craiova, Dolj, Romania
Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943, Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945, Cluj-Napoca, , Romania
Oncomed SRL /ID# 127598, Timisoara, , Romania
Sverdlovsk Regional Oncology Dispensary /ID# 130950, Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
Regional Oncology Dispensary /ID# 125936, Kursk, Tatarstan, Respublika, Russian Federation
Duplicate_archangel Clinical Oncology /ID# 126031, Arkhangelsk, , Russian Federation
Altay Regional Oncological Dispesary /ID# 127160, Barnaul, , Russian Federation
Belgorod Oncology Dispensary /ID# 129315, Belgorod, , Russian Federation
Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395, Saratov, , Russian Federation
LLC BioEq Ltd. /ID# 134529, St. Petersburg, , Russian Federation
Siberian State Medical University /ID# 127161, Tomsk, , Russian Federation
Volgograd Regional Clinical Oncology Dispensary /ID# 124952, Volzhsky, , Russian Federation
National University Hospital /ID# 125315, Singapore, , Singapore
Johns Hopkins Singapore IMC /ID# 125316, Singapore, , Singapore
GVI Oncology /ID# 125321, Gqeberha, Eastern Cape, South Africa
University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499, Bloemfontein, Free State, South Africa
Wits Clinical Research Site /ID# 125317, Johannesburg, Gauteng, South Africa
Medical Oncology Ctr Rosebank /ID# 125322, Johannesburg, Gauteng, South Africa
Sandton Oncology Medical Group PTY Ltd /ID# 125323, Johannesburg, Gauteng, South Africa
Mary Potter Oncology Centre /ID# 133269, Pretoria, Gauteng, South Africa
The Oncology Centre /ID# 126104, Durban, Kwazulu-Natal, South Africa
Netcare Oncology Intervent Ctr /ID# 125320, Cape Town, Western Cape, South Africa
Cancercare Outeniqua Oncology Centre /ID# 125319, George, Western Cape, South Africa
Hospital Santa Creu i Sant Pau /ID# 124963, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 124962, Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 124960, Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 124961, Malaga, , Spain
Hospital Clinico Universitario de Valencia /ID# 124959, Valencia, , Spain
Skane University hospital /ID# 124966, Malmo, Skane Lan, Sweden
Norrlands University hospital /ID# 124967, Umea, Vasterbottens Lan, Sweden
Sahlgrenska University Hospital /ID# 124965, Gothenburg, Vastra Gotalands Lan, Sweden
Linkoping University Hospital /ID# 126795, Linkoping, , Sweden
Duplicate_Karolinska Univ Sjukhuset /ID# 124964, Solna, , Sweden
Uppsala University Hospital /ID# 126512, Uppsala, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575, Kaohsiung, , Taiwan
National Taiwan University Hospital /ID# 125324, Taipei City, , Taiwan
Hacettepe University Faculty of Medicine /ID# 125336, Ankara, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337, Ankara, , Turkey
Duplicate_Akdeniz University Medical Fac /ID# 125339, Antalya, , Turkey
Bezmi Alem Univ Med Fac Hosp /ID# 127901, Istanbul, , Turkey
Istanbul University Istanbul Medical Faculty /ID# 145144, Istanbul, , Turkey
Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968, Dnipro, , Ukraine
Donetsk Regional Antitumor Ctr /ID# 124970, Donetsk, , Ukraine
Communal non-profit enterprise Regional Center of Oncology /ID# 124972, Kharkiv, , Ukraine
Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974, Lviv, , Ukraine
Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969, Poltava, , Ukraine
Zaporizhzhia Med. Academy MOH /ID# 129800, Zaporizhia, , Ukraine
ME Kryviy Rih Oncology Dispensary /ID# 129806, Кривий Ріг, , Ukraine
University Hospitals Bristol /ID# 128343, Bristol, Bristol, City Of, United Kingdom
Hull University Teaching Hospitals NHS Trust /ID# 133030, Hull, East Riding Of Yorkshire, United Kingdom
Nottingham University Hospitals NHS Trust /ID# 125340, Nottingham, Nottinghamshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 125342, Birmingham, , United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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