Clinical trial NCT02163694: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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 Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer Gene 2 (BRCA2) germline mutation.
3. Breast cancer must be Human Epidermal Growth Factor Receptor 2 (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. Eastern Cooperative Oncology Group (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.

   * 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.
2. 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).
3. Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors.
4. Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.

   * 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
5. 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.
6. Active CNS metastases or leptomeningeal disease.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.
measure: Clinical Benefit Rate (CBR)
timeFrame: Through the end of Week 24
measure: Objective Response Rate (ORR)
timeFrame: Approximately 8 years from randomization
measure: Progression-Free Survival on Subsequent Therapy (PFS2)
timeFrame: Approximately 8 years from randomization
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Ctr /ID# 125011
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences /ID# 124992
state: Arkansas
city: Duarte
country: United States
facility: City of Hope /ID# 127117
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research & Excellence (cCARE) /ID# 136078
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego /ID# 124991
state: California
city: Newport Beach
country: United States
facility: Hematology and Oncology Assoc /ID# 130058
state: California
city: Santa Ana
country: United States
facility: Cancer Research Collaboration /ID# 128860
state: California
city: Whittier
country: United States
facility: Icri /Id# 128520
state: California
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 124983
state: Colorado
city: Denver
country: United States
facility: Saint Joseph Hospital /ID# 131768
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital /ID# 133509
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Cancer Institute, Boca /ID# 125013
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital /ID# 125012
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital /ID# 128279
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center /ID# 124990
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East /ID# 125007
state: Florida
city: Atlanta
country: United States
facility: Emory Midtown Infectious Disease Clinic /ID# 133192
state: Georgia
city: Decatur
country: United States
facility: The Cancer Ctr at DeKalb Med C /ID# 125024
state: Georgia
city: Chicago
country: United States
facility: University of Illinois - Chicago /ID# 127576
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem /ID# 124996
state: Illinois
city: Zion
country: United States
facility: Midwestern Regional CTC /ID# 124986
state: Illinois
city: Ames
country: United States
facility: McFarland Clinic, PC /ID# 129904
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 125015
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center /ID# 139461
state: Massachusetts
city: Worcester
country: United States
facility: UMass Chan Medical School /ID# 129067
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 134497
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group /ID# 133568
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group /ID# 148471
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital /ID# 125019
state: Michigan
city: Jackson
country: United States
facility: Univ of Mississippi Med Ctr,US /ID# 131352
state: Mississippi
city: Kansas City
country: United States
facility: St. Lukes Cancer Institute /ID# 125023
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 127575
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology Oncology /ID# 132711
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey /ID# 125017
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico /ID# 125349
state: New Mexico
city: New York
country: United States
facility: Beth Israel Medical Center /ID# 125001
state: New York
city: New York
country: United States
facility: Mount Sinai St. Luke's /ID# 125003
state: New York
city: Asheville
country: United States
facility: Mission Cancer Center /ID# 134248
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center /ID# 124999
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University /ID# 125022
state: Ohio
city: Toledo
country: United States
facility: University of Toledo /ID# 134849
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 134229
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network /ID# 130059
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Hosp/Muhlenberg /ID# 130277
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 124997
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital /ID# 135094
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 125005
state: Pennsylvania
city: Arlington
country: United States
facility: Texas Health Physicians Group /ID# 137740
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center /ID# 124989
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 125353
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 125350
state: Vermont
city: Issaquah
country: United States
facility: Swedish Cancer Institute - Issaquah /ID# 131534
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute - Edmonds /ID# 131549
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center /ID# 125021
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Insititute - Ballard /ID# 131548
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties - Tacoma /ID# 125344
state: Washington
city: Berazategui
country: Argentina
facility: COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Clinica Pergamino /ID# 127158
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto de Oncoloia de Rosario /ID# 127157
state: Santa Fe
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral /ID# 127938
city: Kogarah
country: Australia
facility: St George Hospital /ID# 129416
state: New South Wales
city: Randwick
country: Australia
facility: Duplicate_The Prince of Wales Hospital /ID# 124845
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre /ID# 124844
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital /ID# 126731
state: Queensland
city: Bedford Park
country: Australia
facility: Duplicate_Flinders Centre for Innovation /ID# 127535
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital /ID# 124849
state: Tasmania
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 124846
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Private Hospital /ID# 124843
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 126185
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 126450
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 126184
state: Wien
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449
city: Bobruisk
country: Belarus
facility: Bobruysk Interdistrict Onco. /ID# 137729
city: Minsk
country: Belarus
facility: State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223
city: Mogilev
country: Belarus
facility: Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Oncology Dispensary /ID# 125219
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen /ID# 124977
state: Antwerpen
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 124976
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi /ID# 124981
state: Hainaut
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 124980
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975
state: West-Vlaanderen
city: Antwerp
country: Belgium
facility: ZNA Middelheim /ID# 124978
city: Namur
country: Belgium
facility: CHU UCL Namur - Sainte Elisabeth /ID# 124979
city: Toronto
country: Canada
facility: Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882
state: Ontario
city: Montreal
country: Canada
facility: Duplicate_Jewish General Hospital /ID# 124880
state: Quebec
city: Montréal
country: Canada
facility: CHUM - Notre-Dame Hospital /ID# 124879
state: Quebec
city: Quebec City
country: Canada
facility: Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881
state: Quebec
city: Vina Del Mar
country: Chile
facility: Hospital Clinico Vina del Mar /ID# 130100
state: Valparaíso
city: Vina Del Mar
country: Chile
facility: Hospital Clinico Vina del Mar /ID# 148502
state: Valparaíso
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer /ID# 129343
city: Temuco
country: Chile
facility: ICOS - Inst Clinic Oncology /ID# 125236
city: Medellín
country: Colombia
facility: Hospital Pablo Tobon Uribe /ID# 126657
state: Antioquia
city: Monteria
country: Colombia
facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211
state: Cordoba
city: Bogota
country: Colombia
facility: Administradora del Country_S.A-Clinica Del Country /ID# 125255
state: Cundinamarca
city: Bogota
country: Colombia
facility: Hospital Univ San Ignacio /ID# 126655
state: Cundinamarca
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali /ID# 126656
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno /ID# 128176
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav /ID# 124886
city: Hradec Kralove
country: Czechia
facility: Duplicate_FN Hradec Kralove /ID# 127080
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc /ID# 124885
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 124887
city: Copenhagen Ø
country: Denmark
facility: Rigshospitalet /ID# 124891
state: Hovedstaden
city: Vejle
country: Denmark
facility: Sygehus Lillebælt, Vejle /ID# 124892
state: Syddanmark
city: Kesklinna Linnaosa
country: Estonia
facility: East Tallinn Central Hospital /ID# 126475
state: Harjumaa
city: Helsinki
country: Finland
facility: Docrates Cancer Center /ID# 124896
city: Helsinki
country: Finland
facility: Duplicate_Helsinki Univ Central Hospital /ID# 124897
city: Tampere
country: Finland
facility: Duplicate_Tampere University Hospital /ID# 124898
city: Vaasa
country: Finland
facility: Vaasa Central Hospital /ID# 132548
city: Marseille
country: France
facility: Institut Paoli-Calmettes /ID# 124903
state: Bouches-du-Rhone
city: Paris CEDEX 05
country: France
facility: Institut Curie /ID# 124902
state: Ile-de-France
city: St Herblain CEDEX
country: France
facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726
state: Loire-Atlantique
city: Saint-cloud
country: France
facility: Institut Curie - site CLCC René Huguenin /ID# 124904
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 126664
state: Baden-Wuerttemberg
city: Tubingen
country: Germany
facility: Universitaetsklinimum Tuebingen /ID# 129968
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 135230
state: Baden-Wuerttemberg
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln /ID# 126905
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180
city: Munich
country: Germany
facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256
city: Offenbach am Main
country: Germany
facility: Sana Klinikum Offenbach /ID# 126733
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 132485
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911
city: Zalaegerszeg
country: Hungary
facility: Duplicate_Zala Megyei Korhaz /ID# 131341
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 124918
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 130276
state: Tel-Aviv
city: Be'er Sheva
country: Israel
facility: Duplicate_Soroka University Medical Center /ID# 124917
city: Be'Er Ya'Akov
country: Israel
facility: Assaf Harofeh Medical Center /ID# 124915
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 124916
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 130275
city: Jerusalem
country: Israel
facility: Gastroenterology Institute, Division of Medicine /ID# 124919
city: Rehovot
country: Israel
facility: Kaplan Medical Center /ID# 124914
city: Milan
country: Italy
facility: Ospedale San Raffaele IRCCS /ID# 125261
state: Lombardia
city: Milan
country: Italy
facility: IEO -Istituto Europeo di Oncologia /ID# 125260
state: Milano
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262
state: Verona
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico /ID# 126738
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263
city: Goyang
country: Korea, Republic of
facility: National Cancer Center /ID# 125602
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 125599
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 128968
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 125600
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 125601
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 125598
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital /ID# 125264
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital /ID# 125265
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266
city: Vilnius
country: Lithuania
facility: National Cancer Institute /ID# 125267
city: Mérida
country: Mexico
facility: Centro de Estudios Clínicos Especializados /ID# 128680
state: Yucatan
city: Chihuahua
country: Mexico
facility: Centro Oncologico de Chihuahua /ID# 128679
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cancerología INCAN /ID# 128676
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 124935
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 129069
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 129068
city: Bergen
country: Norway
facility: Haukeland University Hospital /ID# 150177
state: Hordaland
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalistyczny /ID# 127258
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii Lukaszczyka /ID# 124938
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999
state: Lodzkie
city: Rzeszow
country: Poland
facility: MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939
state: Podkarpackie
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony /ID# 126998
state: Warminsko-mazurskie
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510
state: Porto
city: Faro
country: Portugal
facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 126511
city: Porto
country: Portugal
facility: IPO Porto FG, EPE /ID# 125297
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research, LLC /ID# 126043
city: San Juan
country: Puerto Rico
facility: San Juan Municipal Hospital /ID# 124695
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948
state: Dolj
city: Bucharest
country: Romania
facility: Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945
city: Timisoara
country: Romania
facility: Oncomed SRL /ID# 127598
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Dispensary /ID# 130950
state: Sverdlovskaya Oblast
city: Kursk
country: Russian Federation
facility: Regional Oncology Dispensary /ID# 125936
state: Tatarstan, Respublika
city: Arkhangelsk
country: Russian Federation
facility: Duplicate_archangel Clinical Oncology /ID# 126031
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncological Dispesary /ID# 127160
city: Belgorod
country: Russian Federation
facility: Belgorod Oncology Dispensary /ID# 129315
city: Saratov
country: Russian Federation
facility: Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395
city: St. Petersburg
country: Russian Federation
facility: LLC BioEq Ltd. /ID# 134529
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University /ID# 127161
city: Volzhsky
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary /ID# 124952
city: Singapore
country: Singapore
facility: National University Hospital /ID# 125315
city: Singapore
country: Singapore
facility: Johns Hopkins Singapore IMC /ID# 125316
city: Gqeberha
country: South Africa
facility: GVI Oncology /ID# 125321
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499
state: Free State
city: Johannesburg
country: South Africa
facility: Wits Clinical Research Site /ID# 125317
state: Gauteng
city: Johannesburg
country: South Africa
facility: Medical Oncology Ctr Rosebank /ID# 125322
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group PTY Ltd /ID# 125323
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre /ID# 133269
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre /ID# 126104
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Netcare Oncology Intervent Ctr /ID# 125320
state: Western Cape
city: George
country: South Africa
facility: Cancercare Outeniqua Oncology Centre /ID# 125319
state: Western Cape
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 124963
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 124962
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 124960
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 124961
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 124959
city: Malmo
country: Sweden
facility: Skane University hospital /ID# 124966
state: Skane Lan
city: Umea
country: Sweden
facility: Norrlands University hospital /ID# 124967
state: Vasterbottens Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital /ID# 124965
state: Vastra Gotalands Lan
city: Linkoping
country: Sweden
facility: Linkoping University Hospital /ID# 126795
city: Solna
country: Sweden
facility: Duplicate_Karolinska Univ Sjukhuset /ID# 124964
city: Uppsala
country: Sweden
facility: Uppsala University Hospital /ID# 126512
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 125324
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine /ID# 125336
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337
city: Antalya
country: Turkey
facility: Duplicate_Akdeniz University Medical Fac /ID# 125339
city: Istanbul
country: Turkey
facility: Bezmi Alem Univ Med Fac Hosp /ID# 127901
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty /ID# 145144
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Ctr /ID# 124970
city: Kharkiv
country: Ukraine
facility: Communal non-profit enterprise Regional Center of Oncology /ID# 124972
city: Lviv
country: Ukraine
facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969
city: Zaporizhia
country: Ukraine
facility: Zaporizhzhia Med. Academy MOH /ID# 129800
city: Кривий Ріг
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary /ID# 129806
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol /ID# 128343
state: Bristol, City Of
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust /ID# 133030
state: East Riding Of Yorkshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust /ID# 125340
state: Nottinghamshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 125342
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.