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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02163694
Recruitment Status : Recruiting
First Posted : June 16, 2014
Last Update Posted : November 13, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Veliparib Drug: Carboplatin Drug: Paclitaxel Other: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 30, 2014
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Veliparib with Carboplatin and Paclitaxel
Veliparib on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.
Drug: Veliparib
Veliparib on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.
Other Name: ABT-888
Drug: Carboplatin
Day 1 of 21-day cycle
Drug: Paclitaxel
Day 1 of 21-day cycle
Other Name: Taxol
Placebo Comparator: Placebo with Carboplatin and Paclitaxel
Placebo on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.
Drug: Carboplatin
Day 1 of 21-day cycle
Drug: Paclitaxel
Day 1 of 21-day cycle
Other Name: Taxol
Other: Placebo
Placebo on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.

Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Number of days from the date the subject is randomized to the date the subject experiences a confirmed event of disease progression or to the date of death if disease progression is not reached

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Number of days from the day the subject is randomized to the date of the subject's death

  2. Clinical benefit rate (CBR) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Progression-free rate at 24 weeks from the Kaplan-Meier curve for time to progression

  3. Objective response rate (ORR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    Proportion of subjects with a complete or partial objective response

  4. Progression-free survival 2 (PFS2) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Days from randomization to the second objective radiographic progression or death of any cause after the first objective radiographic progression, whichever occurs first

  5. Duration of overall response (DOR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    Number of days from the day the criteria are met for complete response or partial response (whichever is recorded first) to the date of progressive disease

Other Outcome Measures:
  1. Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    Change in ECOG performance status

  2. Change in quality of life (QOL) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Assessed via survey

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic. Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent.
  2. Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation.
  3. Breast cancer must be HER2-negative.
  4. Measurable or non-measurable (but radiologically evaluable) disease per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT) scan (within 28 days of randomization) with at least one lesion outside previously irradiated areas.
  5. ECOG Performance status of 0 to 2.
  6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).

Exclusion Criteria:

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

    • 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 or neoadjuvant).
  3. Prior therapy with 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 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163694

Contact: Abbvie Emerging Med 844-893-5525 AbbVie@emergingmed.com

  Hide Study Locations
United States, Arizona
Banner MD Anderson Cancer Center /ID# 125011 Recruiting
Gilbert, Arizona, United States, 85234
United States, Arkansas
University of Arkansas for Medical Sciences /ID# 124992 Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope National Medical Center /ID# 127117 Recruiting
Duarte, California, United States, 91010-3000
California Cancer Associates for Research and Excellence /ID# 136078 Recruiting
Fresno, California, United States, 93720
Ucsd /Id# 124991 Recruiting
La Jolla, California, United States, 92093-0698
Hematology and Oncology Associates of Greater Newport, Inc. /ID# 130058 Recruiting
Newport Beach, California, United States, 92663
Cancer Research Collaboration, Inc. /ID# 128860 Recruiting
Santa Ana, California, United States, 92705
American Institute of Research /ID# 129501 Not yet recruiting
Whittier, California, United States, 90603
Innovative Clinical Research Institute /ID# 128520 Recruiting
Whittier, California, United States, 90603
Innovative Clinical Research Institute /ID# 129823 Not yet recruiting
Whittier, California, United States, 90603
United States, Colorado
University of Colorado Cancer Center /ID# 124983 Recruiting
Aurora, Colorado, United States, 80045
Saint Joseph Hospital, Cancer Centers of Colorado /ID# 131768 Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Norwalk Hospital /ID# 133509 Recruiting
Norwalk, Connecticut, United States, 06856
United States, Florida
Lynn Cancer Institute, Boca Ration Regional Hospital /ID# 125013 Recruiting
Boca Raton, Florida, United States, 33486
Holy Cross Hospital /ID# 125012 Withdrawn
Fort Lauderdale, Florida, United States, 33308
Sacred Heart Hospital /ID# 128279 Withdrawn
Pensacola, Florida, United States, 32504
Moffitt Cancer Center and Research Institute /ID# 124990 Recruiting
Tampa, Florida, United States, 33612
Florida Cancer Specialists /ID# 125007 Recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
Emory University Hospital /ID# 133192 Recruiting
Atlanta, Georgia, United States, 30322
The Cancer Center at DeKalb Medical Center /ID# 125024 Recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
University of Illinois at Chicago /ID# 127576 Recruiting
Chicago, Illinois, United States, 60612
Evanston Hospital /ID# 124996 Withdrawn
Evanston, Illinois, United States, 60201
Midwestern Regional Medical Center /ID# 124986 Withdrawn
Zion, Illinois, United States, 60099
United States, Iowa
McFarland Clinic, PC /ID# 129904 Withdrawn
Ames, Iowa, United States, 50010-3014
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Ctr at Johns Hopkins /ID# 125015 Recruiting
Baltimore, Maryland, United States, 21287-0013
United States, Massachusetts
Baystate Medical Center /ID# 139461 Recruiting
Springfield, Massachusetts, United States, 01199
UMass Memorial Medical Center /ID# 129067 Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Hospital /ID# 134497 Recruiting
Detroit, Michigan, United States, 48202
Spectrum Health Medical Group /ID# 133568 Recruiting
Grand Rapids, Michigan, United States, 49503
Spectrum Health Medical Group /ID# 148471 Not yet recruiting
Grand Rapids, Michigan, United States, 49503
William Beaumont Hospital /ID# 125019 Recruiting
Royal Oak, Michigan, United States, 48073
United States, Mississippi
University of Mississippi Medical Center /ID# 131352 Withdrawn
Jackson, Mississippi, United States, 39213
United States, Missouri
St. Lukes Cancer Institute /ID# 125023 Recruiting
Kansas City, Missouri, United States, 64111
Washington University School of Medicine /ID# 127575 Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Hematology Oncology, PC /ID# 132711 Recruiting
Lincoln, Nebraska, United States, 68506
United States, New Jersey
The Cancer Institute of New Jersey, Rutgers /ID# 125017 Not yet recruiting
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
CHRISTUS St. Vincent Regional Cancer Center /ID# 136010 Recruiting
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center /ID# 125349 Recruiting
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center /ID# 138069 Withdrawn
Albuquerque, New Mexico, United States, 87106
United States, New York
Beth Israel Medical Center /ID# 125001 Recruiting
New York, New York, United States, 10011
St. Lukes Roosevelt Hospital Center /ID# 125003 Recruiting
New York, New York, United States, 10011
Weill Cornell Medical College of Cornell University /ID# 158132 Not yet recruiting
New York, New York, United States, 10065
United States, North Carolina
Cancer Care of WNC, PA /ID# 134248 Recruiting
Asheville, North Carolina, United States, 28801
Duke University Medical Center /ID# 124999 Recruiting
Durham, North Carolina, United States, 27701
United States, Ohio
The Ohio State University Medical Center /ID# 125022 Withdrawn
Columbus, Ohio, United States, 43210
University of Toledo /ID# 134849 Recruiting
Toledo, Ohio, United States, 43614
United States, Oregon
Oregon Health & Science University (OHSU) /ID# 134229 Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital/Muhlenberg (NORI) /ID# 130277 Withdrawn
Allentown, Pennsylvania, United States, 18102
Lehigh Valley Health Network/Lehigh Valley Hospital /ID# 130059 Withdrawn
Allentown, Pennsylvania, United States, 18103
Penn State Univ and Milton S. Hershey Medical Center /ID# 124997 Recruiting
Hershey, Pennsylvania, United States, 17033
Allegheny General Hospital /ID# 135094 Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Allegheny Valley Hospital /ID# 135900 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
Forbes Hospital /ID# 135282 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
Magee Womens Hospital of UPMC /ID# 125005 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
UPMC East /ID# 144441 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Texas Health Physicians Group /ID# 137740 Recruiting
Arlington, Texas, United States, 76012
UT Southwestern Medical Center /ID# 124989 Recruiting
Dallas, Texas, United States, 75390-8852
The University of Texas - MD Anderson Cancer Center /ID# 125353 Recruiting
Houston, Texas, United States, 77030
United States, Vermont
Fletcher Allen Health Care, Inc. /ID# 125350 Recruiting
Burlington, Vermont, United States, 05401
United States, Washington
Swedish Cancer Institute /ID# 125021 Recruiting
Seattle, Washington, United States, 98104
Swedish Cancer Institute /ID# 131534 Recruiting
Seattle, Washington, United States, 98104
Swedish Cancer Institute /ID# 131548 Recruiting
Seattle, Washington, United States, 98104
Swedish Cancer Institute /ID# 131549 Recruiting
Seattle, Washington, United States, 98104
Northwest Medical Specialties, PLLC /ID# 125344 Recruiting
Tacoma, Washington, United States, 98405
Northwest Medical Specialties, PLLC /ID# 132228 Not yet recruiting
Tacoma, Washington, United States, 98405
Northwest Medical Specialties, PLLC /ID# 132229 Not yet recruiting
Tacoma, Washington, United States, 98405
Northwest Medical Specialties, PLLC /ID# 132230 Not yet recruiting
Tacoma, Washington, United States, 98405
Rainier Physicians, PC /ID# 132231 Not yet recruiting
Tacoma, Washington, United States, 98405
Rainier Physicians, PC /ID# 132232 Not yet recruiting
Tacoma, Washington, United States, 98405
Rainier Physicians, PC /ID# 132233 Not yet recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield Clinic - Marshfield Center /ID# 132317 Withdrawn
Marshfield, Wisconsin, United States, 54449
Centro de Oncologia e Investigacion Buenos Aires (COIBA) /ID# 124839 Recruiting
Berazategui, Buenos Aires, Argentina, B1884BBF
Centro Oncologico Riojano Integral (CORI) /ID# 127938 Recruiting
La Rioja, Argentina, F5300COE
Centro de Investigacion Pergamino SA - Clinica Pergamino /ID# 127158 Recruiting
Pergamino, Argentina, B2700CPM
Instituto de Oncologia de Rosario /ID# 127157 Recruiting
Rosario, Santa Fe, Argentina, S2000KZE
Flinders Centre for Innovation in Cancer /ID# 127535 Completed
Bedford Park, Australia, 5042
The Townsville Hospital and Health Services /ID# 126731 Recruiting
Douglas, Australia, 4814
Royal Hobart Hospital /ID# 124849 Recruiting
Hobart, Australia, 7000
St. George Hospital /ID# 129416 Completed
Kogarah, Australia, 2217
Hollywood Private Hospital /ID# 124843 Recruiting
Nedlands, Australia, 6009
Royal Melbourne Hospital /ID# 124846 Recruiting
Parkville, Australia, 3052
The Prince of Wales Hospital /ID# 124845 Recruiting
Randwick, Australia, 2031
Southern Medical Day Care Center /ID# 124844 Recruiting
Wollongong, Australia, 2500
Medizinische Universitat Graz /ID# 126450 Recruiting
Graz, Austria, 8036
Krankenhaus der Elisabethinen Linz GmbH /ID# 126185 Recruiting
Linz, Austria, 4020
LKH Salzburg and Paracelsus /ID# 126449 Recruiting
Salzburg, Austria, 5020
Medical University of Vienna /ID# 126184 Recruiting
Vienna, Austria, 1090
Bobruisk Inter-district oncology dispensary /ID# 137729 Recruiting
Bobruysk, Belarus, 213825
Republican Research and Practice Centre of Oncology /ID# 125223 Recruiting
Lesnoy, Belarus, 223040
Mogilev Regional Clinical Oncology Dispensary /ID# 137728 Recruiting
Mogilev, Belarus, 212018
Vitebsk Regional Clinical Oncology Dispensary /ID# 125219 Recruiting
Vitebsk, Belarus, 210603
ZNA Middelheim /ID# 124978 Recruiting
Antwerp, Belgium, 2020
AZ St-Jan Brugge-Oostende AV - Campus Sint Jan /ID# 124975 Recruiting
Bruges, Belgium, 8000
Cliniques Universitaires Saint-Luc /ID# 124976 Recruiting
Brussels, Belgium, 1200
Grand Hopital de Charleroi /ID# 124981 Recruiting
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen /ID# 124977 Recruiting
Edegem, Belgium, 2650
Universitair Ziekenhuis Leuven /ID# 124980 Recruiting
Leuven, Belgium, 3000
Clinique Sainte-Elisabeth (CMSE) /ID# 124979 Recruiting
Namur, Belgium, 5000
Hopital Notre Dame /ID# 124879 Recruiting
Montreal, Canada, H2L 4M1
Jewish General Hospital, Sir Mortimer B. Davis /ID# 124880 Recruiting
Montreal, Canada, H3T 1E2
CHU du Quebec, Hopital du Saint Sacrement (CHUQ) /ID# 124881 Recruiting
Quebec, Canada, G1S 4L8
Sunnybrook Health Sciences Centre /ID# 124882 Recruiting
Toronto, Canada, M4N 3M5
Instituto Nacional del Cancer /ID# 129343 Recruiting
Santiago, Chile, 1010
ICOS - Institute Clinic Oncology del Sur /ID# 125236 Recruiting
Temuco, Chile
Hospital Clinico Vina del Mar /ID# 130100 Recruiting
Vina del Mar, Chile
Hospital Clinico Vina del Mar /ID# 148502 Recruiting
Vina del Mar, Chile
Centro de Investigaciones Clinicas CIC /ID# 125255 Recruiting
Bogota, Colombia
Hospital Universitario San Ignacio /ID# 126655 Recruiting
Bogota, Colombia
Centro Medico Imbanaco /ID# 126656 Recruiting
Cali, Colombia, 76001000
Hospital Pablo Tobon Uribe /ID# 126657 Recruiting
Medellin, Colombia
Hospital Pablo Tobon Uribe /ID# 138483 Withdrawn
Medellin, Colombia
Instituto Medico de Alta Tecnologia Oncomedica S.A. (IMAT) /ID# 129211 Recruiting
Monteria, Colombia
Fakultni Nemocnice Brno /ID# 128176 Recruiting
Brno, Czechia, 625 00
Masarykuv onkologicky ustav /ID# 124886 Recruiting
Brno, Czechia, 656 53
Fakultni Nemocnice Hradec Kralove /ID# 127080 Withdrawn
Hradec Kralove, Czechia, 500 05
Fakultni Nemocnice Olomouc /ID# 124885 Recruiting
Olomouc, Czechia, 775 20
Vseobecna Fakultni Nemocnice a I. LF UK v Praze /ID# 124887 Recruiting
Prague 2, Czechia, 128 08
Rigshospitalet, Finsen Centre /ID# 124891 Completed
Copenhagen, Denmark, DK 2100
Vejle Sygehus /ID# 124892 Recruiting
Vejle, Denmark, 7100
East Tallinn Central Hospital /ID# 126475 Recruiting
Tallinn - Harju District, Estonia, 11312
Helsinki University Central Hospital /ID# 124897 Recruiting
Helsinki, Finland, 00029
Docrates Cancer Center /ID# 124896 Recruiting
Helsinki, Finland, 00180
Tampere University Hospital /ID# 124898 Recruiting
Tampere, Finland, 33520
Vaasa Central Hospital /ID# 132548 Recruiting
Vaasa, Finland, 65130
Institut Paoli-Calmettes /ID# 124903 Recruiting
Marseille Cedex 09, France, 13009
Institut Curie /ID# 124902 Recruiting
Paris, France, 75005
Hopital Rene Huguenin, Institut Curie /ID# 124904 Recruiting
Saint Cloud, France, 92210
Insititut de Cancerologie de l'Ouest -Centre Rene Gauducheau /ID# 137726 Recruiting
Saint Herblain, France, 44805
Uniklinik Koln /ID# 126905 Terminated
Cologne, Germany, 50931
Universitaetklinikum Dresden /ID# 127180 Recruiting
Dresden, Germany, 01307
Klinikum der Ruprecht-Karls-Universitaet /ID# 126664 Recruiting
Heidelberg, Germany, 69120
Klinikum rechts der Isar der TU Munich /ID# 125256 Recruiting
Munich, Germany, 81675
Sana Klinikum Offenbach /ID# 126733 Recruiting
Offenbach, Germany, 63069
Universitaets-Frauenklinik /ID# 129968 Recruiting
Tuebingen, Germany, 72076
Universitaetsklinikum Ulm /ID# 135230 Recruiting
Ulm, Germany, 89075
III Sz Szueleszeti Belggyogyaszati Klinika /ID# 132485 Recruiting
Budapest, Hungary, H-1125
Pecsi Tudomanyegyetem /ID# 125259 Recruiting
Pecs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911 Recruiting
Szolnok, Hungary, 5000
Zala Megyei Korhaz /ID# 131341 Recruiting
Zalaegerszeg, Hungary, 8900
Soroka University Medical Center /ID# 124917 Recruiting
Be'er-Sheva, Israel, 84101
Rambam Health Care Campus /ID# 124916 Recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 130275 Recruiting
Jerusalem, Israel, 91031-02
Hadassah University Hospital /ID# 124919 Recruiting
Jerusalem, Israel, 91120
The Chaim Sheba Medical Center /ID# 124918 Recruiting
Ramat Gan, Israel, 5265601
Kaplan Medical Center /ID# 124914 Recruiting
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center /ID# 130276 Recruiting
Tel Aviv, Israel, 64239
Assaf Harofeh Medical Center /ID# 124915 Recruiting
Zerifin, Israel, 70300
Centro di Riferimento Oncologico (CRO) - IRCCS di Aviano /ID# 126738 Recruiting
Aviano (PN), Italy, 33081
Ospedale San Raffaele IRCCS /ID# 125261 Recruiting
Milan, Italy, 20132
Istituto Europeo di Oncologia /ID# 125260 Recruiting
Milan, Italy, 20141
Ospedale Sacro Cuore /ID# 125262 Recruiting
Negrar (Verona), Italy, 37024
Azienda Ospedaliera Bianchi Melacrino Morelli /ID# 125263 Recruiting
Reggio Calabria, Italy, 89125
Korea, Republic of
National Cancer Center /ID# 125602 Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Korea University Anam Hospital /ID# 128968 Recruiting
Seoul, Korea, Republic of, 02841
Seoul National University Hospital /ID# 125600 Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital /ID# 125599 Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center /ID# 125601 Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center /ID# 125598 Recruiting
Seoul, Korea, Republic of, 06351
Daugavpils Regional Hospital /ID# 128175 Withdrawn
Daugavpils, Latvia, LV-5417
Pauls Stradins Clinical University Hospital /ID# 125264 Recruiting
Riga, Latvia, 1002
Riga East Clinical University Hospital /ID# 125265 Recruiting
Riga, Latvia, 1079
Hospital of Lithuanian Univ of Health Sciences Kauno kliniko /ID# 125266 Recruiting
Kaunas, Lithuania, LT-50009
National Cancer Institute /ID# 125267 Recruiting
Vilnius, Lithuania, 08660
Centro Oncologico de Chihuahua /ID# 128679 Recruiting
Chihuahua, Mexico, 31216
Centro Multidisciplinario para el Desarrollo /ID# 128680 Recruiting
Merida, Yuc, Mexico, 97133
Instituto Nacional del Cancer (INCAN) /ID# 128676 Recruiting
Tlapan, Mexico, 14080
University Medical Center Groningen /ID# 129069 Recruiting
Groningen, Netherlands, 9713 GZ
Maastricht University Medical Center /ID# 129068 Recruiting
Maastricht, Netherlands, 6229 HX
Erasmus Medisch Centrum /ID# 124935 Recruiting
Rotterdam, Netherlands, 3075 EA
Haukeland University Hospital /ID# 124937 Recruiting
Bergen, Norway, 5021
Centrum Onkologii im. Prof. Franciszka Lukaszczyka /ID# 124938 Recruiting
Bydgoszcz, Poland, 85-796
Wojewodzki Szpital Zespolony w Elblagu /ID# 126998 Recruiting
Elblag, Poland, 82-300
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat /ID# 126999 Recruiting
Lodz, Poland, 93 513
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 124939 Completed
Rzeszow, Poland, 35-085
Wojewodzki Szpital Specjalistyczny we Wroclawiu /ID# 127258 Recruiting
Wroclaw, Poland, 51-124
Instituto Portugues de Oncologia de Coimbra F.G., EPE /ID# 126506 Withdrawn
Coimbra, Portugal, 3000-075
Centro Hospitalar do Algarve, EPE /ID# 125298 Recruiting
Faro, Portugal, 8000-386
Hospital de Santa Maria /ID# 125299 Recruiting
Lisbon, Portugal, 1649-035
Instituto Portugues Oncologia do Porto Francisco Gentil, EPE /ID# 125297 Recruiting
Porto, Portugal, 4200-072
Centro Hospitalar de Sao Joao, E.P.E.(CHSJ-HSJ) /ID# 126508 Recruiting
Porto, Portugal, 4200-319
Unidade Local Saude Matosinhos, EPE-Hospital Pedro Hispano /ID# 126511 Recruiting
Senhora Da Hora, Matosinhos, Portugal, 4464-513
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E /ID# 126510 Recruiting
Vila Nova de Gaia, Portugal, 4434-502
Puerto Rico
Ad-Vance Medical Research, LLC /ID# 126043 Recruiting
Ponce, Puerto Rico, 00717
San Juan Municipal Hospital /ID# 124695 Withdrawn
San Juan, Puerto Rico, 00935
lnstitutul Oncologic Prof. Dr. Alexandru Trestioreanu /ID# 124943 Recruiting
Bucharest, Romania, 022328
Institute of Oncology Prof. Dr. I. Chiricuta /ID# 124946 Withdrawn
Cluj-Napoca, Romania, 400015
Spitalul Clinic Judetean de Urgenta Cluj-Napoca /ID# 124945 Recruiting
Cluj-Napoca, Romania, 400349
Sc Oncolab Srl /Id# 124948 Recruiting
Craiova, Romania, 200347
Oncomed SRL /ID# 127598 Recruiting
Timisoara, Romania, 300239
Russian Federation
archangel Clinical Oncology Dispensary /ID# 126031 Recruiting
Arkhangelsk, Russian Federation, 163045
Altay Regional Oncologic Dispensary /ID# 127160 Recruiting
Barnaul, Russian Federation, 656049
Belgorod Oncology Dispensary /ID# 129315 Recruiting
Belgorod, Russian Federation, 308000
Sverdlovsk Regional Oncology Dispansaray /ID# 130950 Recruiting
Ekaterinburg, Russian Federation, 620036
Kursk Regional Oncology Dispensary /ID# 125936 Recruiting
Kursk, Russian Federation, 305035
Russian Scientific Research Centre of Radiology /ID# 139395 Recruiting
Moscow, Russian Federation, 117997
LLC BioEq Ltd. /ID# 134529 Recruiting
Saint-Petersburg, Russian Federation, 197342
Federal state budget educational Institution /ID# 127161 Recruiting
Tomsk, Russian Federation, 634050
Volgograd Regional Oncological Dispensary # 3 /ID# 124952 Recruiting
Volzhskiy, Russian Federation, 404130
National University Hospital /ID# 125315 Recruiting
Singapore, Singapore, 119074
Gleneagles Medical Centre /ID# 125300 Terminated
Singapore, Singapore, 258499
Johns Hopkins Singapore International Medical Centre /ID# 125316 Recruiting
Singapore, Singapore, 308433
South Africa
Universitas Annexe /ID# 128499 Recruiting
Bloemfontein, South Africa, 9301
The Oncology Centre /ID# 126104 Recruiting
Durban, South Africa, 4001
GVI Outeniqua Oncology Unit /ID# 125319 Recruiting
George, South Africa, 6530
Coertse, Sauer en Vennote Inc /ID# 125320 Recruiting
Goodwood, N1-City, South Africa, 7460
University of Witwatersrand Oncology /ID# 125317 Withdrawn
Johannesburg, South Africa, 2193
The Medical Oncology Centre of Rosebank /ID# 125322 Recruiting
Johannesburg, South Africa, 2196
Sandton Oncology Centre /ID# 125323 Recruiting
Johannesburg, South Africa, 2199
GVI Oncology /ID# 125321 Recruiting
Port Elizabeth, South Africa, 6045
Mary Potter Oncology Centre /ID# 133269 Recruiting
Pretoria, South Africa, 0181
Hospital Santa Creu i Sant Pau /ID# 124963 Recruiting
Barcelona, Spain, 08026
Hospital General Universitario Gregorio Maranon /ID# 124962 Recruiting
Madrid, Spain, 28007
Hospital Universitario Madrid Sanchinarro /ID# 124960 Recruiting
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de la Victoria /ID# 124961 Recruiting
Malaga, Spain, 29010
Hospital Clinico Universitario de Valencia /ID# 124959 Recruiting
Valencia, Spain, 46010
Sahlgrenska University Hospital /ID# 124965 Completed
Gothenburg, Sweden, 413 45
University Hospital Linkoping /ID# 126795 Withdrawn
Linkoping, Sweden, 581 85
Skanes Universitetssjukhus /ID# 124966 Recruiting
Malmo, Sweden, SE-205 02
Karolinska University Hospital, Solna /ID# 124964 Recruiting
Stockholm, Sweden, 171 76
Norrlands Universitetssjukhus Umea /ID# 124967 Completed
Umea, Sweden, SE-901 85
Uppsala University Hospital /ID# 126512 Recruiting
Uppsala, Sweden, SE-751 85
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575 Recruiting
Kaohsiung City, Taiwan, 80756
National Taiwan University Hospital /ID# 125324 Recruiting
Taipei City, Taiwan, 10002
Hacettepe University School of Medicine /ID# 125336 Recruiting
Ankara, Altindag, Turkey, 06100
Dr. Abdurrahman Yurtaslan Ankara Oncology Research /ID# 125337 Recruiting
Ankara, Turkey, 6200
Akdeniz University Medical Faculty /ID# 125339 Recruiting
Antalya, Turkey, 07059
Bezmi alem Vakif Universitesi Tip Fakultesi /ID# 127901 Recruiting
Istanbul, Turkey, 34093
Istanbul Universitesi Cerrahpasa Tip Fakultesi /ID# 145144 Recruiting
Istanbul, Turkey, 34098
Dokuz Eylul University /ID# 127900 Withdrawn
Izmir, Turkey, 35340
Cherkassy Regional Oncology Ctr Cherkassy Regional Counsel /ID# 124970 Recruiting
Cherkassy, Ukraine, 18009
City Multi-Field Clinical Hospital #4 of Dnipropetrovsk /ID# 124968 Recruiting
Dnipropetrovsk, Ukraine, 49102
Kharkiv Regional Clinical Oncology Center /ID# 124972 Recruiting
Kharkiv, Ukraine, 61070
Kriyorizskiy Oncology Dispensary of Dnipropetrovsk /ID# 129806 Recruiting
Kryvyi Rih, Ukraine, 50048
Lviv State Oncology Local Treatment and Diagnostic Centre /ID# 124974 Recruiting
Lviv, Ukraine, 79031
Poltava Regional Clinical Oncology Center /ID# 124969 Recruiting
Poltava, Ukraine, 36011
Zaporizhzhia Medical Academy of Postgraduate Education MOH /ID# 129800 Recruiting
Zaporizhzhia, Ukraine, 69040
United Kingdom
University of Birmingham /ID# 125342 Recruiting
Birmingham, United Kingdom, B15 2TT
Bristol Haematology and Oncology Centre /ID# 128343 Recruiting
Bristol, United Kingdom, BS2 8ED
Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS /ID# 133030 Recruiting
Cottingham, United Kingdom, HU16 5JQ
Nottingham University Hospitals NHS Trust /ID# 125340 Recruiting
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Study Director: David Maag, PhD AbbVie
More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02163694     History of Changes
Other Study ID Numbers: M12-914
2014-000345-70 ( EudraCT Number )
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by AbbVie:
Breast Cancer
BRCA Mutation
Metastatic Breast Cancer
Genetic breast cancer
Locally recurrent
PARP Inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors