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

NCT ID: NCT02163694

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 513 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-08
• Study Completion Date: 2024-01-25

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Veliparib Placebo with Carboplatin and Paclitaxel

Placebo 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.

Group Type: ACTIVE_COMPARATOR

Veliparib Placebo

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Veliparib with Carboplatin and Paclitaxel

Veliparib 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.

Group Type: EXPERIMENTAL

Veliparib

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Interventions

Veliparib Placebo

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.

Intervention Type: DRUG

Veliparib

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.

Intervention Type: DRUG

Carboplatin

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.

Intervention Type: DRUG

Paclitaxel

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.

Intervention Type: DRUG

Other Intervention Names

ABT-888

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

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

St 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 Province, 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

Medizinische Universitaet Graz /ID# 126450

Graz, Styria, Austria

Ordensklinikum Linz GmbH Elisabethinen /ID# 126185

Linz, Upper Austria, Austria

Medizinische Universitaet Wien /ID# 126184

Vienna, Vienna, Austria

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

Salzburg, , Austria

Bobruysk Interdistrict Onco. /ID# 137729

Babruysk, , 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, Brussels Capital, 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

Bruges, 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

CHUM - Notre-Dame Hospital /ID# 124879

Montreal, Quebec, Canada

Duplicate_Jewish General Hospital /ID# 124880

Montreal, Quebec, Canada

Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881

Québec, Quebec, Canada

Hospital Clinico Vina del Mar /ID# 130100

Viña del Mar, Región de Valparaíso, Chile

Hospital Clinico Vina del Mar /ID# 148502

Viña del Mar, Región de 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

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

Bogota, Cundinamarca, Colombia

Hospital Univ San Ignacio /ID# 126655

Bogota, Cundinamarca, Colombia

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

Montería, Departamento de Córdoba, 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 Králové, , Czechia

Fakultni nemocnice Olomouc /ID# 124885

Olomouc, , Czechia

Vseobecna fakultni nemocnice v Praze /ID# 124887

Prague, , Czechia

Rigshospitalet /ID# 124891

Copenhagen Ø, Capital Region, Denmark

Sygehus Lillebælt, Vejle /ID# 124892

Vejle, Region Syddanmark, Denmark

East Tallinn Central Hospital /ID# 126475

Kesklinn, Harju, 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 de Cancérologie de l'Ouest René Gauducheau /ID# 137726

Saint-Herblain, Loire-Atlantique, France

Institut Curie - site CLCC René Huguenin /ID# 124904

Saint-Cloud, , France

Institut Curie /ID# 124902

Paris, Île-de-France Region, France

Universitaetsklinik Heidelberg /ID# 126664

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinimum Tuebingen /ID# 129968

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm /ID# 135230

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Koeln /ID# 126905

Cologne, North Rhine-Westphalia, 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, , Germany

Semmelweis Egyetem /ID# 132485

Budapest, , Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259

Pécs, , 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, Tel Aviv, Israel

Duplicate_Soroka University Medical Center /ID# 124917

Beersheba, , Israel

Assaf Harofeh Medical Center /ID# 124915

Be’er Ya‘aqov, , 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, Lombardy, 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

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, Yucatán, Mexico

Centro Oncologico de Chihuahua /ID# 128679

Chihuahua City, , Mexico

Instituto Nacional de Cancerología INCAN /ID# 128676

Mexico City, , Mexico

Erasmus Medisch Centrum /ID# 124935

Rotterdam, South 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

Centrum Onkologii Lukaszczyka /ID# 124938

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny /ID# 127258

Wroclaw, Lower Silesian Voivodeship, Poland

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

Rzeszów, Podkarpackie Voivodeship, Poland

Wojewodzki Szpital Zespolony /ID# 126998

Elblag, Warmian-Masurian Voivodeship, Poland

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

Lodz, Łódź Voivodeship, Poland

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

Vila Nova de Gaia, Porto District, 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

Lisbon, , Portugal

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

Matosinhos Municipality, , 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

Timișoara, , Romania

Sverdlovsk Regional Oncology Dispensary /ID# 130950

Yekaterinburg, Sverdlovsk Oblast, Russia

Regional Oncology Dispensary /ID# 125936

Kursk, Tatarstan, Respublika, Russia

Duplicate_archangel Clinical Oncology /ID# 126031

Arkhangelsk, , Russia

Altay Regional Oncological Dispesary /ID# 127160

Barnaul, , Russia

Belgorod Oncology Dispensary /ID# 129315

Belgorod, , Russia

LLC BioEq Ltd. /ID# 134529

Saint Petersburg, , Russia

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

Saratov, , Russia

Siberian State Medical University /ID# 127161

Tomsk, , Russia

Volgograd Regional Clinical Oncology Dispensary /ID# 124952

Volzhsky, , Russia

National University Hospital /ID# 125315

Singapore, , Singapore

Johns Hopkins Singapore IMC /ID# 125316

Singapore, , Singapore

GVI Oncology /ID# 125321

Port Elizabeth, 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

National Cancer Center /ID# 125602

Goyang, Gyeonggido, South Korea

Yonsei University Health System Severance Hospital /ID# 125599

Seoul, Seoul Teugbyeolsi, South Korea

Korea University Anam Hospital /ID# 128968

Seoul, , South Korea

Seoul National University Hospital /ID# 125600

Seoul, , South Korea

Asan Medical Center /ID# 125601

Seoul, , South Korea

Samsung Medical Center /ID# 125598

Seoul, , South Korea

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

Málaga, , Spain

Hospital Clinico Universitario de Valencia /ID# 124959

Valencia, , Spain

Skane University hospital /ID# 124966

Malmo, Skåne County, Sweden

Norrlands University hospital /ID# 124967

Umeå, Västerbotten County, Sweden

Sahlgrenska University Hospital /ID# 124965

Gothenburg, Västra Götaland County, Sweden

Linkoping University Hospital /ID# 126795

Linköping, , 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 City, , Taiwan

National Taiwan University Hospital /ID# 125324

Taipei, , Taiwan

Hacettepe University Faculty of Medicine /ID# 125336

Ankara, , Turkey (Türkiye)

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

Ankara, , Turkey (Türkiye)

Duplicate_Akdeniz University Medical Fac /ID# 125339

Antalya, , Turkey (Türkiye)

Bezmi Alem Univ Med Fac Hosp /ID# 127901

Istanbul, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty /ID# 145144

Istanbul, , Turkey (Türkiye)

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

ME Kryviy Rih Oncology Dispensary /ID# 129806

Kryvyi Rih, , 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

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

Countries

United States; Argentina; Australia; Austria; Belarus; Belgium; Canada; Chile; Colombia; Czechia; Denmark; Estonia; Finland; France; Germany; Hungary; Israel; Italy; Latvia; Lithuania; Mexico; Netherlands; Norway; Poland; Portugal; Puerto Rico; Romania; Russia; Singapore; South Africa; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35403245 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34917174 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34243076 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34131001 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32861273 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-000345-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M12-914

Identifier Type: -

Identifier Source: org_study_id