Clinical Trial Details

NCT ID: NCT02163694
Date Last Changed: August 31, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Veliparib, Carboplatin, Paclitaxel and Placebo to evaluate Metastatic Breast Cancer

Research Study 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

Purpose

The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 99 Years
Overall Status
Recruiting
Lead Sponsor
AbbVie
Duration
46 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 99 Years

Inclusion Criteria:

  1. Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic. Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent.

  2. Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation.

  3. Breast cancer must be HER2-negative.

  4. Measurable or non-measurable (but radiologically evaluable) disease per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT) scan (within 28 days of randomization) with at least one lesion outside previously irradiated areas.

  5. ECOG Performance status of 0 to 2.

  6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).

Exclusion Criteria:

  1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease.

  2. Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months.

  3. Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy.

  4. Progressed or recurred within 12 months of completing platinum therapy or received > 1 prior line of platinum therapy for breast cancer in any setting (adjuvant or neoadjuvant).

  5. Prior therapy with PARP inhibitors.

  6. Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.

  7. Prior taxane therapy for metastatic breast cancer is allowed if the patient received ≤ 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of progression or if taxane therapy for metastatic disease was > 12 months prior to C1D-2.

  8. Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2

  9. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

  10. Active CNS metastases or leptomeningeal disease.

Site Locations (197)

Country State City Zip Facility and Contact
United States Arizona Gilbert 85234 Banner MD Anderson Cancer Center /ID# 125011
United States California Duarte 91010-3000 City of Hope National Medical Center /ID# 127117
United States California Fresno 93720 California Cancer Associates for Research and Excellence /ID# 136078
United States California La Jolla 92093-0698 University of California San Diego Health System /ID# 124991
United States California Newport Beach 92663 Hematology and Oncology Associates of Greater Newport, Inc. /ID# 130058
United States California Santa Ana 92705 Cancer Research Collaboration, Inc. /ID# 128860
United States California Whittier 90603 Innovative Clinical Research Institute /ID# 128520
United States Colorado Aurora 80045 University of Colorado Cancer Center /ID# 124983
United States Colorado Denver 80218 Comprehensive Cancer Center at St. Joseph Hospital /ID# 131768
United States Connecticut Norwalk 06856 Norwalk Hospital /ID# 133509
Richard Frank, MD
United States Florida Boca Raton 33486 Lynn Cancer Institute, Boca Ration Regional Hospital /ID# 125013
United States Florida Tampa 33612 Moffitt Cancer Center and Research Institute /ID# 124990
United States Florida West Palm Beach 33401 Florida Cancer Specialists /ID# 125007
United States Georgia Atlanta 30322 Emory University Hospital /ID# 133192
United States Georgia Decatur 30033 The Cancer Center at DeKalb Medical Center /ID# 125024
United States Illinois Chicago 60612 University of Illinois at Chicago /ID# 127576
United States Maryland Baltimore 21287-0013 The Sidney Kimmel Comprehensive Cancer Ctr at Johns Hopkins /ID# 125015
Vered Stearns, MD
United States Massachusetts Springfield 01199 Baystate Medical Center /ID# 139461
Grace Makari-Judson, MD
United States Massachusetts Worcester 01655 UMass Memorial Medical Center /ID# 129067
United States Michigan Detroit 48202 Henry Ford Hospital /ID# 134497
United States Michigan Grand Rapids 49503 Spectrum Health Medical Group /ID# 133568
United States Michigan Royal Oak 48073 William Beaumont Hospital /ID# 125019
United States Missouri Kansas City 64111 St. Lukes Cancer Institute /ID# 125023
Timothy Pluard, MD
United States Missouri Saint Louis 63110 Washington University School of Medicine /ID# 127575
Foluso Ademuyiwa, MD
United States Nebraska Lincoln 68506 Nebraska Hematology Oncology, PC /ID# 132711
Mark Hutchins, MD
United States New Mexico Albuquerque 87106 CHRISTUS St. Vincent Regional Cancer Center /ID# 136010
United States New Mexico Albuquerque 87106 University of New Mexico Cancer Center /ID# 125349
United States New York New York 10011 Beth Israel Medical Center /ID# 125001
United States New York New York 10011 St. Lukes Roosevelt Hospital Center /ID# 125003
United States North Carolina Asheville 28801 Cancer Care of WNC, PA /ID# 134248
United States North Carolina Durham 27701 Duke University Medical Center /ID# 124999
P Kelly Marcom, MD
United States Ohio Toledo 43614 University of Toledo /ID# 134849
United States Oregon Portland 97239 Oregon Health & Science University (OHSU) /ID# 134229
United States Pennsylvania Hershey 17033 Penn State Univ and Milton S. Hershey Medical Center /ID# 124997
United States Pennsylvania Pittsburgh 15212 Allegheny General Hospital /ID# 135094
United States Pennsylvania Pittsburgh 15232 Magee Womens Hospital of UPMC /ID# 125005
United States Texas Arlington 76012 Texas Health Physicians Group /ID# 137740
Alfred DiStefano, MD
United States Texas Dallas 75390-8852 UT Southwestern Medical Center /ID# 124989
United States Texas Houston 77030 The University of Texas - MD Anderson Cancer Center /ID# 125353
Banu Arun, MD
United States Vermont Burlington 05401 Fletcher Allen Health Care, Inc. /ID# 125350
United States Washington Seattle 98104 Swedish Cancer Institute /ID# 125021
Henry Kaplan, MD
United States Washington Seattle 98104 Swedish Cancer Institute /ID# 131534
United States Washington Seattle 98104 Swedish Cancer Institute /ID# 131548
United States Washington Seattle 98104 Swedish Cancer Institute /ID# 131549
United States Washington Tacoma 98405 Northwest Medical Specialties, PLLC /ID# 125344
Francis Senecal, MD
Argentina Berazategui, Buenos Aires B1884BBF Centro de Oncologia e Investigacion Buenos Aires (COIBA) /ID# 124839
Argentina La Rioja F5300COE Centro Oncologico Riojano Integral (CORI) /ID# 127938
Argentina Pergamino B2700CPM Centro de Investigacion Pergamino SA - Clinica Pergamino /ID# 127158
Argentina Rosario, Santa Fe S2000KZE Instituto de Oncologia de Rosario /ID# 127157
Australia Douglas 4814 The Townsville Hospital and Health Services /ID# 126731
Australia Hobart 7000 Royal Hobart Hospital /ID# 124849
Australia Nedlands 6009 Hollywood Private Hospital /ID# 124843
Australia Parkville 3052 Royal Melbourne Hospital /ID# 124846
Australia Randwick 2031 The Prince of Wales Hospital /ID# 124845
Australia Wollongong 2500 Southern Medical Day Care Center /ID# 124844
Austria Graz 8036 Medizinische Universitat Graz /ID# 126450
Austria Linz 4020 Krankenhaus der Elisabethinen Linz GmbH /ID# 126185
Austria Salzburg 5020 LKH Salzburg and Paracelsus /ID# 126449
Austria Vienna 1090 Medical University of Vienna /ID# 126184
Belarus Bobruysk 213825 Bobruysk Interdistric Oncology Dispensary /ID# 137729
Belarus Lesnoy 223040 Republican Research and Practice Centre of Oncology /ID# 125223
Belarus Mogilev 212018 Mogilev Regional Clinical Oncology Dispensary /ID# 137728
Belarus Vitebsk 210603 Vitebsk Regional Clinical Oncology Dispensary /ID# 125219
Belgium Antwerp 2020 ZNA Middelheim /ID# 124978
Belgium Bruges 8000 AZ St-Jan Brugge-Oostende AV - Campus Sint Jan /ID# 124975
Belgium Brussels 1200 Cliniques Universitaires Saint-Luc /ID# 124976
Belgium Brussels 1200 Grand Hopital de Charleroi /ID# 124981
Belgium Edegem 2650 Universitair Ziekenhuis Antwerpen /ID# 124977
Belgium Leuven 3000 Universitair Ziekenhuis Leuven /ID# 124980
Belgium Namur 5000 Clinique Sainte-Elisabeth (CMSE) /ID# 124979
Canada Montreal H2L 4M1 Hopital Notre Dame /ID# 124879
Canada Montreal H4A 3T2 McGill University /ID# 124880
Canada Quebec G1S 4L8 CHU du Quebec, Hopital du Saint Sacrement (CHUQ) /ID# 124881
Canada Toronto M4N 3M5 Sunnybrook Health Sciences Centre /ID# 124882
Chile Santiago National Cancer Institute /ID# 129343
Chile Temuco ICOS - Institute Clinic Oncology del Sur /ID# 125236
Chile Vina del Mar Hospital Clinico Vina del Mar /ID# 130100
Chile Vina del Mar Hospital Clinico Vina del Mar /ID# 148502
Colombia Bogota Centro de Investigaciones Clinicas CIC /ID# 125255
Colombia Bogota Hospital Universitario San Ignacio /ID# 126655
Colombia Cali 76001000 Centro Medico Imbanaco /ID# 126656
Colombia Medellin Hospital Pablo Tobon Uribe /ID# 126657
Colombia Monteria Instituto Medico de Alta Tecnologia Oncomedica S.A. (IMAT) /ID# 129211
Czechia Brno 625 00 Fakultni Nemocnice Brno /ID# 128176
Czechia Brno 656 53 Masarykuv onkologicky ustav /ID# 124886
Czechia Olomouc 775 20 Fakultni Nemocnice Olomouc /ID# 124885
Czechia Prague 2 128 08 Vseobecna Fakultni Nemocnice a I. LF UK v Praze /ID# 124887
Denmark Vejle 7100 Vejle Sygehus /ID# 124892
Estonia Tallinn - Harju District 11312 East Tallinn Central Hospital /ID# 126475
Finland Helsinki 00029 Helsinki University Central Hospital /ID# 124897
Finland Helsinki 00180 Docrates Cancer Center /ID# 124896
Finland Tampere 33520 Tampere University Hospital /ID# 124898
Finland Vaasa 65130 Vaasa Central Hospital /ID# 132548
France Marseille Cedex 09 13009 Institut Paoli-Calmettes /ID# 124903
France Paris 75005 Institut Curie /ID# 124902
France Saint Cloud 92210 Hopital Rene Huguenin, Institut Curie /ID# 124904
France Saint Herblain 44805 Insititut de Cancerologie de l'Ouest -Centre Rene Gauducheau /ID# 137726
Germany Dresden 01307 Universitaetklinikum Dresden /ID# 127180
Germany Heidelberg 69120 Klinikum der Ruprecht-Karls-Universitaet /ID# 126664
Germany Munich 81675 Klinikum rechts der Isar der TU Munich /ID# 125256
Germany Offenbach 63069 Sana Klinikum Offenbach /ID# 126733
Germany Tuebingen 72076 Universitaets-Frauenklinik /ID# 129968
Germany Ulm 89075 Universitaetsklinikum Ulm /ID# 135230
Hungary Budapest H-1125 III Sz Szueleszeti Belggyogyaszati Klinika /ID# 132485
Hungary Pecs 7624 Pecsi Tudomanyegyetem /ID# 125259
Hungary Szolnok 5000 Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911
Hungary Zalaegerszeg 8900 Zala Megyei Korhaz /ID# 131341
Israel Be'er-Sheva 84101 Soroka University Medical Center /ID# 124917
Israel Haifa 3109601 Rambam Health Care Campus /ID# 124916
Israel Jerusalem 91031-02 Shaare Zedek Medical Center /ID# 130275
Israel Jerusalem 91120 Hadassah University Hospital /ID# 124919
Israel Ramat Gan 5265601 The Chaim Sheba Medical Center /ID# 124918
Israel Rehovot 76100 Kaplan Medical Center /ID# 124914
Israel Tel Aviv 64239 Tel Aviv Sourasky Medical Center /ID# 130276
Israel Zerifin 70300 Assaf Harofeh Medical Center /ID# 124915
Italy Aviano (PN) 33081 Centro di Riferimento Oncologico (CRO) - IRCCS di Aviano /ID# 126738
Italy Milan 20132 Ospedale San Raffaele IRCCS /ID# 125261
Italy Milan 20141 Istituto Europeo di Oncologia /ID# 125260
Italy Negrar (Verona) 37024 Ospedale Sacro Cuore /ID# 125262
Italy Reggio Calabria 89125 Azienda Ospedaliera Bianchi Melacrino Morelli /ID# 125263
Korea, Republic of Gyeonggi-do 10408 National Cancer Center /ID# 125602
Korea, Republic of Seoul 02841 Korea University Anam Hospital /ID# 128968
Korea, Republic of Seoul 03080 Seoul National University Hospital /ID# 125600
Korea, Republic of Seoul 03722 Severance Hospital /ID# 125599
Korea, Republic of Seoul 05505 Asan Medical Center /ID# 125601
Korea, Republic of Seoul 06351 Samsung Medical Center /ID# 125598
Latvia Riga 1002 Pauls Stradins Clinical University Hospital /ID# 125264
Latvia Riga 1079 Riga East Clinical University Hospital /ID# 125265
Lithuania Kaunas LT-50009 Hospital of Lithuanian Univ of Health Sciences Kauno kliniko /ID# 125266
Lithuania Vilnius 08660 National Cancer Institute /ID# 125267
Mexico Chihuahua 31216 Centro Oncologico de Chihuahua /ID# 128679
Mexico Merida, Yuc 97133 Centro Multidisciplinario para el Desarrollo /ID# 128680
Mexico Tlapan 14080 Instituto Nacional del Cancer (INCAN) /ID# 128676
Netherlands Groningen 9713 GZ University Medical Center Groningen /ID# 129069
Netherlands Maastricht 6229 HX Maastricht University Medical Center /ID# 129068
Netherlands Rotterdam 3075 EA Erasmus Medisch Centrum /ID# 124935
Norway Bergen 5021 Haukeland University Hospital /ID# 124937
Poland Bydgoszcz 85-796 Centrum Onkologii im. Prof. Franciszka Lukaszczyka /ID# 124938
Poland Elblag 82-300 Wojewodzki Szpital Zespolony w Elblagu /ID# 126998
Poland Lodz 93 513 Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat /ID# 126999
Poland Wroclaw 51-124 Wojewodzki Szpital Specjalistyczny we Wroclawiu /ID# 127258
Portugal Faro 8000-386 Centro Hospitalar do Algarve, EPE /ID# 125298
Portugal Lisbon 1649-035 Hospital de Santa Maria /ID# 125299
Portugal Porto 4200-072 Instituto Portugues Oncologia do Porto Francisco Gentil, EPE /ID# 125297
Portugal Porto 4200-319 Centro Hospitalar de Sao Joao, E.P.E.(CHSJ-HSJ) /ID# 126508
Portugal Senhora da Hora, Matosinhos 4464-513 Unidade Local Saude Matosinhos, EPE-Hospital Pedro Hispano /ID# 126511
Portugal Vila Nova de Gaia 4434-502 Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E /ID# 126510
Puerto Rico Ponce 00717 Ad-Vance Medical Research, LLC /ID# 126043
Romania Bucharest 022328 lnstitutul Oncologic Prof. Dr. Alexandru Trestioreanu /ID# 124943
Romania Cluj-Napoca 400349 Spitalul Clinic Judetean de Urgenta Cluj-Napoca /ID# 124945
Romania Craiova 200347 Sc Oncolab Srl /Id# 124948
Romania Timisoara 300239 Oncomed SRL /ID# 127598
Russian Federation Arkhangelsk 163045 archangel Clinical Oncology Dispensary /ID# 126031
Russian Federation Barnaul 656049 Altay Regional Oncologic Dispensary /ID# 127160
Russian Federation Belgorod 308000 Belgorod Oncology Dispensary /ID# 129315
Russian Federation Ekaterinburg 620036 Sverdlovsk Regional Oncology Dispansaray /ID# 130950
Russian Federation Kursk 305035 Kursk Regional Oncology Dispensary /ID# 125936
Russian Federation Moscow 117997 Russian Scientific Research Centre of Radiology /ID# 139395
Russian Federation Saint-Petersburg 197342 LLC BioEq Ltd. /ID# 134529
Russian Federation Tomsk 634050 Federal state budget educational Institution /ID# 127161
Russian Federation Volzhskiy 404130 Volgograd Regional Oncological Dispensary # 3 /ID# 124952
Singapore Singapore 119074 National University Hospital /ID# 125315
Singapore Singapore 308433 Johns Hopkins Singapore International Medical Centre /ID# 125316
South Africa Bloemfontein 9301 Universitas Annexe /ID# 128499
South Africa Durban 4001 The Oncology Centre /ID# 126104
South Africa George 6530 GVI Outeniqua Oncology Unit /ID# 125319
South Africa Goodwood, N1-City 7460 Coertse, Sauer en Vennote Inc /ID# 125320
South Africa Johannesburg 2196 The Medical Oncology Centre of Rosebank /ID# 125322
South Africa Johannesburg 2199 Sandton Oncology Centre /ID# 125323
South Africa Port Elizabeth 6045 GVI Oncology /ID# 125321
South Africa Pretoria 0181 Mary Potter Oncology Centre /ID# 133269
Spain Barcelona 08026 Hospital Santa Creu i Sant Pau /ID# 124963
Spain Madrid 28007 Hospital General Universitario Gregorio Maranon /ID# 124962
Spain Madrid 28050 Hospital Universitario Madrid Sanchinarro /ID# 124960
Spain Malaga 29010 Hospital Clinico Universitario Virgen de la Victoria /ID# 124961
Spain Valencia 46010 Hospital Clinico Universitario de Valencia /ID# 124959
Sweden Malmo SE-205 02 Skanes Universitetssjukhus /ID# 124966
Sweden Stockholm 171 76 Karolinska University Hospital, Solna /ID# 124964
Sweden Uppsala SE-751 85 Uppsala University Hospital /ID# 126512
Taiwan Kaohsiung City 80756 Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575
Taiwan Taipei City 10002 National Taiwan University Hospital /ID# 125324
Turkey Ankara, Altindag 06100 Hacettepe University School of Medicine /ID# 125336
Turkey Ankara 6200 Dr. Abdurrahman Yurtaslan Ankara Oncology Research /ID# 125337
Turkey Antalya 07059 Akdeniz University Medical Faculty /ID# 125339
Turkey Istanbul 34093 Bezmi alem Vakif Universitesi Tip Fakultesi /ID# 127901
Turkey Istanbul 34098 Istanbul Universitesi Cerrahpasa Tip Fakultesi /ID# 145144
Ukraine Cherkassy 18009 Cherkassy Regional Oncology Ctr Cherkassy Regional Counsel /ID# 124970
Ukraine Dnipropetrovsk 49102 City Multi-Field Clinical Hospital #4 of Dnipropetrovsk /ID# 124968
Ukraine Kharkiv 61070 Kharkiv Regional Clinical Oncology Center /ID# 124972
Ukraine Kryvyi Rih 50048 Kriyorizskiy Oncology Dispensary of Dnipropetrovsk /ID# 129806
Ukraine Lviv 79031 Lviv State Oncology Local Treatment and Diagnostic Centre /ID# 124974
Ukraine Poltava 36011 Poltava Regional Clinical Oncology Center /ID# 124969
Ukraine Zaporizhzhia 69040 Zaporizhzhia Medical Academy of Postgraduate Education MOH /ID# 129800
United Kingdom Birmingham B15 2TT University of Birmingham /ID# 125342
United Kingdom Bristol BS2 8ED Bristol Haematology and Oncology Centre /ID# 128343
United Kingdom Cottingham HU16 5JQ Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS /ID# 133030
United Kingdom Nottingham NG5 1PB Nottingham University Hospitals NHS Trust /ID# 125340

Contact

Abbvie Emerging Med
844-893-5525
E-mail:

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