AzTrials
AzTrials

Metastatic Breast CancerPhase 3NCT02163694

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

A Phase 3 study testing Veliparib, Carboplatin and Paclitaxel in people with Metastatic Breast Cancer, run by AbbVie at 219 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Veliparib, Carboplatin and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
513 participants
Where
219 sitesin 37 countries
Study dates
8 Apr 2014to 25 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Suspected deleterious or deleterious Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer Gene 2 (BRCA2) germline mutation.
  • Breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
  • Adequate hematologic, renal, and hepatic function (within 28 days of randomization).

Who cannot join

  • More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease.
  • 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.
  • 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.
  • 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, neoadjuvant, or metastatic).
  • Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors.
  • Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.
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  • 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 Cycle 1 Day-2 (C1D-2).
  • Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2
  • 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.
  • Active CNS metastases or leptomeningeal disease.

Trial locations and contacts

219 sites in 37 countries.

219 sites in 37 countries

United States56 sites

  • University of New Mexico /ID# 125349

    Albuquerque, New Mexico, 87102-4517

  • Lehigh Valley Health Network /ID# 130059

    Allentown, Pennsylvania, 18103

  • McFarland Clinic, PC /ID# 129904

    Ames, Iowa, 50010

  • Texas Health Physicians Group /ID# 137740

    Arlington, Texas, 76012

  • Mission Cancer Center /ID# 134248

    Asheville, North Carolina, 28801

  • Emory Midtown Infectious Disease Clinic /ID# 133192

    Atlanta, Georgia, 30322

  • Univ of Colorado Cancer Center /ID# 124983

    Aurora, Colorado, 80045

  • Johns Hopkins University /ID# 125015

    Baltimore, Maryland, 21287

  • Lehigh Valley Hosp/Muhlenberg /ID# 130277

    Bethlehem, Pennsylvania, 18017

  • Lynn Cancer Institute, Boca /ID# 125013

    Boca Raton, Florida, 33486

  • University of Vermont Medical Center /ID# 125350

    Burlington, Vermont, 05401-1473

  • University of Illinois - Chicago /ID# 127576

    Chicago, Illinois, 60607

  • The Ohio State University /ID# 125022

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center /ID# 124989

    Dallas, Texas, 75390-7208

  • The Cancer Ctr at DeKalb Med C /ID# 125024

    Decatur, Georgia, 30033

  • Saint Joseph Hospital /ID# 131768

    Denver, Colorado, 80218

  • Henry Ford Health System /ID# 134497

    Detroit, Michigan, 48202

  • City of Hope /ID# 127117

    Duarte, California, 91010

  • Duke Cancer Center /ID# 124999

    Durham, North Carolina, 27710-3000

  • NorthShore University HealthSystem /ID# 124996

    Evanston, Illinois, 60201

  • Holy Cross Hospital /ID# 125012

    Fort Lauderdale, Florida, 33308

  • California Cancer Associates for Research & Excellence (cCARE) /ID# 136078

    Fresno, California, 93720

  • Banner MD Anderson Cancer Ctr /ID# 125011

    Gilbert, Arizona, 85234

  • Spectrum Health Medical Group /ID# 133568

    Grand Rapids, Michigan, 49503

  • Spectrum Health Medical Group /ID# 148471

    Grand Rapids, Michigan, 49503

  • Penn State University and Milton S. Hershey Medical Center /ID# 124997

    Hershey, Pennsylvania, 17033

  • University of Texas MD Anderson Cancer Center /ID# 125353

    Houston, Texas, 77030

  • Swedish Cancer Institute - Issaquah /ID# 131534

    Issaquah, Washington, 98029-6201

  • Univ of Mississippi Med Ctr,US /ID# 131352

    Jackson, Mississippi, 39216-4643

  • St. Lukes Cancer Institute /ID# 125023

    Kansas City, Missouri, 64111-5905

  • Moores Cancer Center at UC San Diego /ID# 124991

    La Jolla, California, 92093

  • Nebraska Hematology Oncology /ID# 132711

    Lincoln, Nebraska, 68506

  • University of Arkansas for Medical Sciences /ID# 124992

    Little Rock, Arkansas, 72205

  • Rutgers Cancer Institute of New Jersey /ID# 125017

    New Brunswick, New Jersey, 08901

  • Beth Israel Medical Center /ID# 125001

    New York, New York, 10003

  • Mount Sinai St. Luke's /ID# 125003

    New York, New York, 10025

  • Hematology and Oncology Assoc /ID# 130058

    Newport Beach, California, 92663

  • Norwalk Hospital /ID# 133509

    Norwalk, Connecticut, 06856

  • Sacred Heart Hospital /ID# 128279

    Pensacola, Florida, 32504

  • Allegheny General Hospital /ID# 135094

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh MC /ID# 125005

    Pittsburgh, Pennsylvania, 15260

  • Oregon Health and Science University /ID# 134229

    Portland, Oregon, 97239

  • William Beaumont Hospital /ID# 125019

    Royal Oak, Michigan, 48073-6710

  • Cancer Research Collaboration /ID# 128860

    Santa Ana, California, 92705

  • Swedish Cancer Institute - Edmonds /ID# 131549

    Seattle, Washington, 98104

  • Swedish Medical Center /ID# 125021

    Seattle, Washington, 98104

  • Swedish Cancer Insititute - Ballard /ID# 131548

    Seattle, Washington, 98107-3932

  • Baystate Medical Center /ID# 139461

    Springfield, Massachusetts, 01199

  • Washington University-School of Medicine /ID# 127575

    St Louis, Missouri, 63110

  • Northwest Medical Specialties - Tacoma /ID# 125344

    Tacoma, Washington, 98405

  • Moffitt Cancer Center /ID# 124990

    Tampa, Florida, 33612-9416

  • University of Toledo /ID# 134849

    Toledo, Ohio, 43614

  • Florida Cancer Specialists - East /ID# 125007

    West Palm Beach, Florida, 33401

  • Icri /Id# 128520

    Whittier, California, 90603

  • UMass Chan Medical School /ID# 129067

    Worcester, Massachusetts, 01655

  • Midwestern Regional CTC /ID# 124986

    Zion, Illinois, 60099

Other trials in United States

Russia9 sites

  • Duplicate_archangel Clinical Oncology /ID# 126031

    Arkhangelsk, 163045

  • Altay Regional Oncological Dispesary /ID# 127160

    Barnaul, 656049

  • Belgorod Oncology Dispensary /ID# 129315

    Belgorod, 308010

  • Regional Oncology Dispensary /ID# 125936

    Kursk, Tatarstan, Respublika, 305035

  • LLC BioEq Ltd. /ID# 134529

    Saint Petersburg, 197342

  • Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395

    Saratov, 410012

  • Siberian State Medical University /ID# 127161

    Tomsk, 634050

  • Volgograd Regional Clinical Oncology Dispensary /ID# 124952

    Volzhsky, 404130

  • Sverdlovsk Regional Oncology Dispensary /ID# 130950

    Yekaterinburg, Sverdlovsk Oblast, 620043

Other trials in Russia

South Africa9 sites

  • University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499

    Bloemfontein, Free State, 9301

  • Netcare Oncology Intervent Ctr /ID# 125320

    Cape Town, Western Cape, 7460

  • The Oncology Centre /ID# 126104

    Durban, KwaZulu-Natal, 4091

  • Cancercare Outeniqua Oncology Centre /ID# 125319

    George, Western Cape, 6530

  • Wits Clinical Research Site /ID# 125317

    Johannesburg, Gauteng, 2193

  • Medical Oncology Ctr Rosebank /ID# 125322

    Johannesburg, Gauteng, 2196

  • Sandton Oncology Medical Group PTY Ltd /ID# 125323

    Johannesburg, Gauteng, 2196

  • GVI Oncology /ID# 125321

    Port Elizabeth, Eastern Cape, 6006

  • Mary Potter Oncology Centre /ID# 133269

    Pretoria, Gauteng, 0181

Other trials in South Africa

Australia8 sites

  • Duplicate_Flinders Centre for Innovation /ID# 127535

    Bedford Park, South Australia, 5042

  • Townsville University Hospital /ID# 126731

    Douglas, Queensland, 4814

  • Royal Hobart Hospital /ID# 124849

    Hobart, Tasmania, 7000

  • St George Hospital /ID# 129416

    Kogarah, New South Wales, 2217

  • Hollywood Private Hospital /ID# 124843

    Nedlands, Western Australia, 6009

  • The Royal Melbourne Hospital /ID# 124846

    Parkville, Victoria, 3050

  • Duplicate_The Prince of Wales Hospital /ID# 124845

    Randwick, New South Wales, 2031

  • Southern Medical Day Care Centre /ID# 124844

    Wollongong, New South Wales, 2500

Other trials in Australia

Israel8 sites

  • Assaf Harofeh Medical Center /ID# 124915

    Be’er Ya‘aqov, 70300

  • Duplicate_Soroka University Medical Center /ID# 124917

    Beersheba, 8457101

  • Rambam Health Care Campus /ID# 124916

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 130275

    Jerusalem, 91031

  • Gastroenterology Institute, Division of Medicine /ID# 124919

    Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 124918

    Ramat Gan, Tel Aviv, 5265601

  • Kaplan Medical Center /ID# 124914

    Rehovot, 7661041

  • Tel Aviv Sourasky Medical Center /ID# 130276

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Belgium7 sites

  • ZNA Middelheim /ID# 124978

    Antwerp, 2020

  • Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975

    Bruges, West-Vlaanderen, 8000

  • Grand Hôpital de Charleroi /ID# 124981

    Charleroi, Hainaut, 6000

  • Universitair Ziekenhuis Antwerpen /ID# 124977

    Edegem, Antwerpen, 2650

  • Universitair Ziekenhuis Leuven /ID# 124980

    Leuven, Vlaams-Brabant, 3000

  • CHU UCL Namur - Sainte Elisabeth /ID# 124979

    Namur, 5000

  • UCL Saint-Luc /ID# 124976

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Germany7 sites

  • Universitaetsklinikum Koeln /ID# 126905

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180

    Dresden, 01307

  • Universitaetsklinik Heidelberg /ID# 126664

    Heidelberg, Baden-Wurttemberg, 69120

  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256

    Munich, 81675

  • Sana Klinikum Offenbach /ID# 126733

    Offenbach, 63069

  • Universitaetsklinimum Tuebingen /ID# 129968

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm /ID# 135230

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Ukraine7 sites

  • Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968

    Dnipro, 49102

  • Donetsk Regional Antitumor Ctr /ID# 124970

    Donetsk, 83092

  • Communal non-profit enterprise Regional Center of Oncology /ID# 124972

    Kharkiv, 61070

  • ME Kryviy Rih Oncology Dispensary /ID# 129806

    Kryvyi Rih, 50048

  • Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974

    Lviv, 79031

  • Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969

    Poltava, 36011

  • Zaporizhzhia Med. Academy MOH /ID# 129800

    Zaporizhia, 69040

Other trials in Ukraine

Portugal6 sites

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298

    Faro, 8000-386

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299

    Lisbon, 1649-035

  • Unidade Local de Saúde de Matosinhos, EPE /ID# 126511

    Matosinhos Municipality, 4464-513

  • IPO Porto FG, EPE /ID# 125297

    Porto, 4200-072

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508

    Porto, 4200-319

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

South Korea6 sites

  • National Cancer Center /ID# 125602

    Goyang, Gyeonggido, 10408

  • Yonsei University Health System Severance Hospital /ID# 125599

    Seoul, Seoul Teugbyeolsi, 03722

  • Korea University Anam Hospital /ID# 128968

    Seoul, 02841

  • Seoul National University Hospital /ID# 125600

    Seoul, 03080

  • Asan Medical Center /ID# 125601

    Seoul, 05505

  • Samsung Medical Center /ID# 125598

    Seoul, 06351

Other trials in South Korea

Sweden6 sites

  • Sahlgrenska University Hospital /ID# 124965

    Gothenburg, Västra Götaland County, 413 45

  • Linkoping University Hospital /ID# 126795

    Linköping, 581 85

  • Skane University hospital /ID# 124966

    Malmö, Skåne County, 214 28

  • Duplicate_Karolinska Univ Sjukhuset /ID# 124964

    Solna, 171 64

  • Norrlands University hospital /ID# 124967

    Umeå, Västerbotten County, 581 85

  • Uppsala University Hospital /ID# 126512

    Uppsala, 75185

Other trials in Sweden

Colombia5 sites

  • Administradora del Country_S.A-Clinica Del Country /ID# 125255

    Bogota, Cundinamarca, 110221

  • Hospital Univ San Ignacio /ID# 126655

    Bogota, Cundinamarca, 110231

  • Centro Medico Imbanaco de Cali /ID# 126656

    Cali

  • Hospital Pablo Tobon Uribe /ID# 126657

    Medellín, Antioquia, 50034

  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Czechia5 sites

  • Fakultni Nemocnice Brno /ID# 128176

    Brno, 625 00

  • Masarykuv onkologicky ustav /ID# 124886

    Brno, 656 53

  • Duplicate_FN Hradec Kralove /ID# 127080

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc /ID# 124885

    Olomouc, 779 00

  • Vseobecna fakultni nemocnice v Praze /ID# 124887

    Prague, 128 08

Other trials in Czechia

Italy5 sites

  • Centro di Riferimento Oncologico /ID# 126738

    Aviano, 33081

  • Ospedale San Raffaele IRCCS /ID# 125261

    Milan, Lombardy, 20132

  • IEO -Istituto Europeo di Oncologia /ID# 125260

    Milan, Milano, 20141

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262

    Negrar, Verona, 37024

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263

    Reggio Calabria, 89124

Other trials in Italy

Poland5 sites

  • Centrum Onkologii Lukaszczyka /ID# 124938

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Wojewodzki Szpital Zespolony /ID# 126998

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999

    Lodz, Łódź Voivodeship, 93-513

  • MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939

    Rzeszów, Podkarpackie Voivodeship, 35-021

  • Wojewodzki Szpital Specjalistyczny /ID# 127258

    Wroclaw, Lower Silesian Voivodeship, 51-124

Other trials in Poland

Spain5 sites

  • Hospital Santa Creu i Sant Pau /ID# 124963

    Barcelona, 08041

  • Hospital General Universitario Gregorio Maranon /ID# 124962

    Madrid, 28007

  • Hospital Universitario HM Sanchinarro /ID# 124960

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria /ID# 124961

    Málaga, 29010

  • Hospital Clinico Universitario de Valencia /ID# 124959

    Valencia, 46010

Other trials in Spain

Turkey (Türkiye)5 sites

  • Hacettepe University Faculty of Medicine /ID# 125336

    Ankara, 06100

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337

    Ankara, 06200

  • Duplicate_Akdeniz University Medical Fac /ID# 125339

    Antalya, 07059

  • Bezmi Alem Univ Med Fac Hosp /ID# 127901

    Istanbul, 34093

  • Istanbul University Istanbul Medical Faculty /ID# 145144

    Istanbul, 34093

Other trials in Turkey (Türkiye)

Argentina4 sites

  • COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839

    Berazategui, Buenos Aires, 1884

  • Centro Oncologico Riojano Integral /ID# 127938

    La Rioja, 5300

  • Clinica Pergamino /ID# 127158

    Pergamino, Buenos Aires, 2700

  • Instituto de Oncoloia de Rosario /ID# 127157

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Austria4 sites

  • Medizinische Universitaet Graz /ID# 126450

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Elisabethinen /ID# 126185

    Linz, Upper Austria, 4010

  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449

    Salzburg, 5020

  • Medizinische Universitaet Wien /ID# 126184

    Vienna, State of Vienna, 1090

Other trials in Austria

Belarus4 sites

  • Bobruysk Interdistrict Onco. /ID# 137729

    Babruysk, 213825

  • State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223

    Minsk, 223040

  • Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728

    Mogilev, 212018

  • Vitebsk Regional Clinical Oncology Dispensary /ID# 125219

    Vitebsk, 210603

Other trials in Belarus

Canada4 sites

  • CHUM - Notre-Dame Hospital /ID# 124879

    Montreal, Quebec, H2X 0A9

  • Duplicate_Jewish General Hospital /ID# 124880

    Montreal, Quebec, H3T 1E2

  • Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881

    Québec, Quebec, G1S 4L8

  • Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Chile4 sites

  • Instituto Nacional del Cancer /ID# 129343

    Santiago, 8380455

  • ICOS - Inst Clinic Oncology /ID# 125236

    Temuco, 4810469

  • Hospital Clinico Vina del Mar /ID# 130100

    Viña del Mar, Valparaiso, 2520612

  • Hospital Clinico Vina del Mar /ID# 148502

    Viña del Mar, Valparaiso, 2520612

Other trials in Chile

Finland4 sites

  • Docrates Cancer Center /ID# 124896

    Helsinki, 00180

  • Duplicate_Helsinki Univ Central Hospital /ID# 124897

    Helsinki, 00290

  • Duplicate_Tampere University Hospital /ID# 124898

    Tampere, 33521

  • Vaasa Central Hospital /ID# 132548

    Vaasa, 65130

Other trials in Finland

France4 sites

  • Institut Paoli-Calmettes /ID# 124903

    Marseille, Bouches-du-Rhone, 13009

  • Institut Curie /ID# 124902

    Paris, Île-de-France Region, 75248

  • Institut Curie - site CLCC René Huguenin /ID# 124904

    Saint-Cloud, 92210

  • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726

    Saint-Herblain, Loire-Atlantique, 44805

Other trials in France

Hungary4 sites

  • Semmelweis Egyetem /ID# 132485

    Budapest, 1085

  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259

    Pécs, 7624

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911

    Szolnok, 5000

  • Duplicate_Zala Megyei Korhaz /ID# 131341

    Zalaegerszeg, 8900

Other trials in Hungary

Romania4 sites

  • Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943

    Bucharest, 022328

  • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945

    Cluj-Napoca, 400006

  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948

    Craiova, Dolj, 200347

  • Oncomed SRL /ID# 127598

    Timișoara, 300239

Other trials in Romania

United Kingdom4 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 125342

    Birmingham, B15 2TH

  • University Hospitals Bristol /ID# 128343

    Bristol, Bristol, City of, BS2 8ED

  • Hull University Teaching Hospitals NHS Trust /ID# 133030

    Hull, East Riding Of Yorkshire, HU3 2JZ

  • Nottingham University Hospitals NHS Trust /ID# 125340

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Mexico3 sites

  • Centro Oncologico de Chihuahua /ID# 128679

    Chihuahua City, 31217

  • Centro de Estudios Clínicos Especializados /ID# 128680

    Mérida, Yucatán, 97133

  • Instituto Nacional de Cancerología INCAN /ID# 128676

    Mexico City, 14080

Other trials in Mexico

Netherlands3 sites

  • Universitair Medisch Centrum Groningen /ID# 129069

    Groningen, 9713 GZ

  • Maastricht Universitair Medisch Centrum /ID# 129068

    Maastricht, 6229 HX

  • Erasmus Medisch Centrum /ID# 124935

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

Denmark2 sites

  • Rigshospitalet /ID# 124891

    Copenhagen Ø, Capital Region, 2100

  • Sygehus Lillebælt, Vejle /ID# 124892

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Latvia2 sites

  • Pauls Stradins Clinical University Hospital /ID# 125264

    Riga, 1002

  • Riga East Clinical University Hospital /ID# 125265

    Riga, LV-1079

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266

    Kaunas, 50161

  • National Cancer Institute /ID# 125267

    Vilnius, 08660

Other trials in Lithuania

Puerto Rico2 sites

  • Ad-Vance Medical Research, LLC /ID# 126043

    Ponce, 00717

  • San Juan Municipal Hospital /ID# 124695

    San Juan, 00935

Other trials in Puerto Rico

Singapore2 sites

  • National University Hospital /ID# 125315

    Singapore, 119074

  • Johns Hopkins Singapore IMC /ID# 125316

    Singapore, 308433

Other trials in Singapore

Taiwan2 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575

    Kaohsiung City, 807

  • National Taiwan University Hospital /ID# 125324

    Taipei, 100

Other trials in Taiwan

Estonia1 site

  • East Tallinn Central Hospital /ID# 126475

    Kesklinn, Harju, 10138

Other trials in Estonia

Norway1 site

  • Haukeland University Hospital /ID# 150177

    Bergen, Hordaland, 5021

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Veliparib Placebo, Veliparib, Carboplatin, Paclitaxel
Keywords
PARP Inhibitor, Veliparib, BRCA1, BRCA2, HER2-negative, Locally recurrent, Breast Cancer, Metastatic Breast Cancer, ABT-888, Genetic breast cancer, Paclitaxel, BRCA Mutation, PARP, Carboplatin, BROCADE3
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Veliparib PlaceboDrug

    Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.

  • VeliparibDrug

    Also called ABT-888

    Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.

  • CarboplatinDrug

    Administered intravenously over approximately 15 to 30 minutes at an area under the curve (AUC) of 6 mg/mL/min immediately following paclitaxel infusion on Day 1 of every cycle. The duration of carboplatin infusion may be lengthened according to institutional guidelines.

  • PaclitaxelDrug

    Administered by intravenous infusion over approximately 1 hour at a dose of 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel is to be infused prior to carboplatin on Day 1. Dosing of veliparib/placebo is to be completed before the carboplatin or paclitaxel infusions.

Study groups in NCT02163694
Study groupRoleWhat they receive
Veliparib Placebo with Carboplatin and PaclitaxelActive comparatorPlacebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
Receives: Drug: Veliparib Placebo; Drug: Carboplatin; Drug: Paclitaxel
Veliparib with Carboplatin and PaclitaxelExperimentalVeliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
Receives: Drug: Veliparib; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Time to PFS is defined as the number of days from the date the participant was randomized to the date the participant experiences radiographic disease progression (as determined by the investigators), or to the date of death (all causes of mortality) if disease progression is not reached. All events of disease progression occurring on or before the Primary Analysis Cutoff date of 05 April 2019 were to be included, regardless of whether the event occurred while the participant was still taking study drug or had previously discontinued study drug. PFS was estimated for each treatment group using Kaplan-Meier methodology.

    Measured: From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months

Secondary outcomes (4)

  1. Overall Survival (OS)

    Time to death (overall survival) is defined as the number of days from the date the participant was randomized to the date of the participant's death. All events of death which occur up to the analysis cutoff date are to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant has not died, the data for the participant is to be censored at the date last known to be alive or at the analysis cutoff date if that is earlier.

    The final analysis of OS will occur when the pre-specified number of events has occurred in the ITT population.

    Measured: Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.

  2. Clinical Benefit Rate (CBR)

    The clinical benefit rate (CBR) is defined as the progression-free rate at 24 weeks (168 days), estimated using Kaplan Meier methodology. All events of disease progression in the primary progression free survival analysis database were to be included, regardless of whether the event occurred while the participant was still taking, or had previously discontinued, study drug. If the participant had not yet progressed then their data was to be censored at the date of the last evaluable disease progression assessment. Participants without post-baseline assessments were to be censored at the date of randomization.

    Measured: Through the end of Week 24

  3. Objective Response Rate (ORR)

    The objective response rate (ORR) is calculated as the percentage of participants who have a confirmed partial response (PR) or complete response (CR) based on assessment by the investigators per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. All participants who had at least one measurable lesion at baseline were to be included in the ORR calculation.

    The final analysis of ORR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.

    Measured: Approximately 8 years from randomization

  4. Progression-Free Survival on Subsequent Therapy (PFS2)

    PFS2 is defined as the number of days from the date of randomization to the time of disease progression on subsequent therapy or death from any cause. The distribution of PFS2 was to be estimated for each treatment group using Kaplan-Meier methodology.

    The final analysis of PFS2 will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.

    Measured: Approximately 8 years from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2014 (estimated)
  2. Study start8 Apr 2014
  3. Primary completion5 Apr 2019
  4. Study completion25 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163694
Sponsor's protocol ID
M12-914
Other IDs
2014-000345-70, 2014
Status last verified
Feb 2025
First submitted
19 May 2014
Last updated
19 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Stodtmann S, Eckert D, Joshi R, Nuthalapati S, Ratajczak CK, Menon R, Mensing S, Xiong H. Exposure-Response Model With Time-Varying Predictors to Estimate the Effects of Veliparib in Combination With Carboplatin/Paclitaxel and as Monotherapy: Veliparib Phase 3 Study in BRCA-Mutated Advanced Breast Cancer (BROCADE3) Trial. J Clin Pharmacol. 2022 Oct;62(10):1236-1246. doi: 10.1002/jcph.2061. Epub 2022 May 5.

    PubMed 35403245

  • Ayoub JP, Wildiers H, Friedlander M, Arun BK, Han HS, Puhalla S, Shparyk Y, Jakobsen EH, Wu M, Bach BA, Feng D, Ratajczak CK, Maag D, Dieras V. Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: subgroup analyses by germline BRCA1/2 mutations and hormone receptor status from the phase-3 BROCADE3 trial. Ther Adv Med Oncol. 2021 Dec 9;13:17588359211059601. doi: 10.1177/17588359211059601. eCollection 2021.

    PubMed 34917174

  • Arun BK, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bell-McGuinn KM, Bach BA, Kundu MG, Ratajczak CK, Maag D, Dieras V. Efficacy and safety of first-line veliparib and carboplatin-paclitaxel in patients with HER2- advanced germline BRCA+ breast cancer: Subgroup analysis of a randomised clinical trial. Eur J Cancer. 2021 Sep;154:35-45. doi: 10.1016/j.ejca.2021.05.037. Epub 2021 Jul 6.

    PubMed 34243076

  • Puhalla SL, Dieras V, Arun BK, Kaufman B, Wildiers H, Han HS, Ayoub JP, Stearns V, Yuan Y, Helsten T, Riley-Gillis B, Murphy E, Kundu MG, Wu M, Maag D, Ratajczak CK, Ramathal CY, Friedlander M. Relevance of Platinum-free Interval and BRCA Reversion Mutations for Veliparib Monotherapy after Progression on Carboplatin/Paclitaxel for gBRCA Advanced Breast Cancer (BROCADE3 Crossover). Clin Cancer Res. 2021 Sep 15;27(18):4983-4993. doi: 10.1158/1078-0432.CCR-21-0748. Epub 2021 Jun 15.

    PubMed 34131001

  • Dieras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palacova M, Park YH, Shparyk Y, Yanez E, Khandelwal N, Kundu MG, Dudley M, Ratajczak CK, Maag D, Arun BK. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1269-1282. doi: 10.1016/S1470-2045(20)30447-2. Epub 2020 Aug 27.

    PubMed 32861273

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Veliparib, Carboplatin and Paclitaxel in people with Metastatic Breast Cancer, run by AbbVie at 219 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 219 sites in United States, Russia, South Africa, Australia, Israel and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02163694, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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