Trial record 1 of 1 for:    NCT02163694
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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. Read our disclaimer for details. Identifier: NCT02163694
Recruitment Status : Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : December 7, 2018
Information provided by (Responsible Party):

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: Paclitaxel Drug: Veliparib Drug: Carboplatin Other: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 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
Actual Study Start Date : August 5, 2014
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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: Paclitaxel
Day 1 of 21-day cycle
Other Name: Taxol

Drug: Carboplatin
Day 1 of 21-day cycle

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.

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: Paclitaxel
Day 1 of 21-day cycle
Other Name: Taxol

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

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. 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

  2. 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

  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. 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

  5. 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

Other Outcome Measures:
  1. 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

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT02163694

  Hide Study Locations
United States, California
City of Hope /ID# 127117
Duarte, California, United States, 91010
Ucsd /Id# 124991
La Jolla, California, United States, 92037
Hematology and Oncology Assoc /ID# 130058
Newport Beach, California, United States, 92663
Cancer Research Collaboration, /ID# 128860
Santa Ana, California, United States, 92705
Icri /Id# 128520
Whittier, California, United States, 90603
United States, Colorado
Univ of Colorado Cancer Center /ID# 124983
Aurora, Colorado, United States, 80045
Saint Joseph Hospital /ID# 131768
Denver, Colorado, United States, 80218
United States, Connecticut
Norwalk Hospital /ID# 133509
Norwalk, Connecticut, United States, 06856
United States, Florida
Lynn Cancer Institute, Boca /ID# 125013
Boca Raton, Florida, United States, 33486
Moffitt Cancer Center /ID# 124990
Tampa, Florida, United States, 33612
Florida Cancer Specialists - East /ID# 125007
West Palm Beach, Florida, United States, 33401
United States, Georgia
Emory University Hospital /ID# 133192
Atlanta, Georgia, United States, 30322
The Cancer Ctr at DeKalb Med C /ID# 125024
Decatur, Georgia, United States, 30033
United States, Illinois
University of Illinois - Chicago /ID# 127576
Chicago, Illinois, United States, 60607
United States, Maryland
Johns Hopkins University /ID# 125015
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Baystate Medical Center /ID# 139461
Springfield, Massachusetts, United States, 01199
UMass Memorial Medical Center /ID# 129067
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Health System /ID# 134497
Detroit, Michigan, United States, 48202
Spectrum Health Medical Group /ID# 133568
Grand Rapids, Michigan, United States, 49503
William Beaumont Hospital /ID# 125019
Royal Oak, Michigan, United States, 48073-6710
United States, Missouri
St. Lukes Cancer Institute /ID# 125023
Kansas City, Missouri, United States, 64111-5905
Washington University-School of Medicine /ID# 127575
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Hematology Oncology /ID# 132711
Lincoln, Nebraska, United States, 68506
United States, New Mexico
University of New Mexico /ID# 125349
Albuquerque, New Mexico, United States, 87102
United States, New York
Beth Israel Medical Center /ID# 125001
New York, New York, United States, 10003
Mount Sinai St. Luke's /ID# 125003
New York, New York, United States, 10025
United States, North Carolina
Cancer Care of WNC, PA /ID# 134248
Asheville, North Carolina, United States, 28801
Duke Univ Med Ctr /ID# 124999
Durham, North Carolina, United States, 27710
United States, Ohio
University of Toledo /ID# 134849
Toledo, Ohio, United States, 43614
United States, Oregon
Oregon Health and Science University /ID# 134229
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Penn State University and Milton S. Hershey Medical Center /ID# 124997
Hershey, Pennsylvania, United States, 17033
University of Pittsburgh MC /ID# 125005
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
Texas Health Physicians Group /ID# 137740
Arlington, Texas, United States, 76012
UT Southwestern Medical Center /ID# 124989
Dallas, Texas, United States, 75390-7208
Univ TX, MD Anderson /ID# 125353
Houston, Texas, United States, 77030
United States, Vermont
University of Vermont Medical Center /ID# 125350
Burlington, Vermont, United States, 05401-1473
United States, Washington
Swedish Cancer Institute /ID# 131534
Seattle, Washington, United States, 98104
Swedish Cancer Institute /ID# 131548
Seattle, Washington, United States, 98104
Swedish Cancer Institute /ID# 131549
Seattle, Washington, United States, 98104
Swedish Medical Center /ID# 125021
Seattle, Washington, United States, 98104
Northwest Medical Specialties /ID# 125344
Tacoma, Washington, United States, 98405
Coiba /Id# 124839
Berazategui, Buenos Aires, Argentina, 1884
Centro Oncologico Riojano /ID# 127938
La Rioja, Argentina, 5300
Centro Investigacion Pergamino /ID# 127158
Pergamino, Argentina, 2700
Instituto de Oncologia de Rosa /ID# 127157
Rosario, Santa FE, Argentina, 2000
Australia, New South Wales
St George Hospital /ID# 129416
Kogarah, New South Wales, Australia, 2217
The Prince of Wales Hospital /ID# 124845
Randwick, New South Wales, Australia, 2031
Southern Medical Day Care Ctr /ID# 124844
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
The Townsville Hospital /ID# 126731
Douglas, Queensland, Australia, 4814
Australia, South Australia
Flinders Centre for Innovation /ID# 127535
Adelaide, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital /ID# 124849
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Royal Melbourne Hospital /ID# 124846
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Hollywood Private Hospital /ID# 124843
Nedlands, Western Australia, Australia, 6009
AKH Wien /ID# 126184
Vienna, Wien, Austria, 1090
LKH-Univ. Klinikum Graz /ID# 126450
Graz, Austria, 8036
Ordensklinikum Linz GmbH, Elisabethinen /ID# 126185
Linz, Austria, 4020
LKH Salzburg and Paracelsus /ID# 126449
Salzburg, Austria, 5020
Bobruysk Interdistrict Onco. /ID# 137729
Bobruisk, Belarus, 213825
Belarus Cancer Center N.N. Alexandrov /ID# 125223
Lesnoy, Belarus, 223040
Mogilev Reg Clin Oncology Dis /ID# 137728
Mogilev, Belarus, 212018
Vitebsk Reg Clin Onc Disp /ID# 125219
Vitebsk, Belarus, 210603
Cliniques Universitaires Saint Luc /ID# 124976
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Grand Hôpital de Charleroi /ID# 124981
Charleroi, Hainaut, Belgium, 6000
ZNA Middelheim /ID# 124978
Antwerp, Belgium, 2020
UZ Antwerp /ID# 124977
Edegem, Belgium, 2650
UZ Leuven /ID# 124980
Leuven, Belgium, 3000
CHU UCL Namur /ID# 124979
Namur, Belgium, 5000
Canada, Ontario
Sunnybrook Health Sciences Ctr /ID# 124882
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital /ID# 124880
Montreal, Quebec, Canada, H3T 1E2
CHUM - Notre-Dame Hospital /ID# 124879
Montréal, Quebec, Canada, H2X 0A9
CHUQ-Hospital St. Sacrement /ID# 124881
Quebec City, Quebec, Canada, G1S 4L8
Instituto Nacional del Cancer /ID# 129343
Santiago, Chile, 1010
ICOS - Inst Clinic Oncology /ID# 125236
Temuco, Chile, 4810469
Hospital Clinico Vina del Mar /ID# 130100
Vina Del Mar, Chile, 2520612
Hospital Clinico Vina del Mar /ID# 148502
Vina Del Mar, Chile, 2520612
Administradora del Country_S.A-Clinica Del Country /ID# 125255
Bogota, Cundinamarca, Colombia, 110221
Hospital Univ San Ignacio /ID# 126655
Bogota, Colombia, 110231
Centro Medico Imbanaco de Cali /ID# 126656
Cali, Colombia
Hospital Pablo Tobon Uribe /ID# 126657
Medellín, Colombia
Inst Med Alta Tec Onc (IMAT) /ID# 129211
Montería, Colombia, 230002
Fakultni Nemocnice Olomouc /ID# 124885
Olomouc, Olomoucky Kraj, Czechia, 779 00
Fakultni Nemocnice Brno /ID# 128176
Brno, Czechia, 625 00
Masarykuv onkologikcy ustav /ID# 124886
Brno, Czechia, 656 53
Vseobecna Fakultni Nemocnice /ID# 124887
Prague, Czechia, 128 08
Vejle Sygehus /ID# 124892
Vejle, Syddanmark, Denmark, 7100
Rigshospitalet, Finsen Centre /ID# 124891
Copenhagen, Denmark, 2100
East Tallinn Central Hospital /ID# 126475
Tallinn, Estonia, 10138
Docrates Cancer Center /ID# 124896
Helsinki, Finland, 00180
Helsinki Univ Central Hospital /ID# 124897
Helsinki, Finland, 00290
Tampere University Hospital /ID# 124898
Tampere, Finland, 33521
Vaasa Central Hospital /ID# 132548
Vaasa, Finland, 65130
Institut Curie /ID# 124902
Paris CEDEX 05, Ile-de-France, France, 75248
Institut de Cancer de l'Ouest /ID# 137726
St Herblain CEDEX, Loire-Atlantique, France, 44805
Institut Paoli-Calmettes /ID# 124903
Marseille, France, 13273
Hopital Rene Huguenin /ID# 124904
Saint-cloud, France, 92210
Universitaetsklinik Heidelberg /ID# 126664
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Uniklinik Koln /ID# 126905
Köln, Nordrhein-Westfalen, Germany, 50937
Universitaetsklinikum Ulm /ID# 135230
Ulm, Thueringen, Germany, 89081
Universitaetklinikum Dresden /ID# 127180
Dresden, Germany, 01307
Klinikum recht der Isar der TU /ID# 125256
Munich, Germany, 80802
Sana Klinikum Offenbach /ID# 126733
Offenbach, Germany, 63069
Universitatsklinikum Tubingen /ID# 129968
Tuebingen, Germany, 72076
Pecsi Tudomanyegyetem /ID# 125259
Pécs, Pecs, Hungary, 7624
Semmelweis Egyetem /ID# 132485
Budapest, Hungary, 1085
Jasz-Nagykun-Szolnok Megyei /ID# 124911
Szolnok, Hungary, 5004
Zala Megyei Korhaz /ID# 131341
Zalaegerszeg, Hungary, 8900
Tel Aviv Sourasky Medical Ctr /ID# 130276
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Soroka Medical Ctr /ID# 124917
Be'er Sheva, Israel, 84101
Assaf Harofeh Medical Center /ID# 124915
Be'er Ya'akov, Israel, 70300
Rambam Health Care Campus /ID# 124916
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 130275
Jerusalem, Israel, 91031
Hadassah University Hospital /ID# 124919
Jerusalem, Israel, 91120
Sheba Medical Center /ID# 124918
Ramat Gan, Israel, 5262100
Kaplan Medical Center /ID# 124914
Rehovot, Israel, 76100
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 125262
Negrar, Verona, Italy, 37024
Centro di Riferimento Oncologi /ID# 126738
Aviano, Italy, 33081
Ospedale San Raffaele IRCCS /ID# 125261
Milan, Italy, 20132
Istituto Europeo di Oncologia /ID# 125260
Milan, Italy, 20141
AO Bianchi Melacrino Morelli /ID# 125263
Reggio Calabria, Italy, 89125
Korea, Republic of
National Cancer Center /ID# 125602
Goyang, Gyeonggido, Korea, Republic of, 10408
Severance Hospital /ID# 125599
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 125598
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Korea University Anam Hospital /ID# 128968
Seoul, Korea, Republic of, 02841
Seoul National University Hospital /ID# 125600
Seoul, Korea, Republic of, 03080
Asan Medical Center /ID# 125601
Seoul, Korea, Republic of, 05505
Riga East Clinical Univ Hosp /ID# 125265
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 125264
Riga, Latvia, LV-1002
Hosp Lithuanian Univ Health Sc /ID# 125266
Kovno, Kaunas, Lithuania, 50009
National Cancer Institute /ID# 125267
Vilnius, Lithuania, 08660
Centro Oncologico de Chihuahua /ID# 128679
Chihuahua, Mexico, 31217
Centro Multidisciplinario para /ID# 128680
Mérida, Mexico, 97133
Instituto Nacional del Cancer /ID# 128676
Tlapan, Mexico, 14080
Universitair Medisch Centrum Groningen /ID# 129069
Groningen, Netherlands, 9713 GZ
Maastricht Universitair Medisch Centrum /ID# 129068
Maastricht, Netherlands, 6229 HX
Erasmus Medisch Centrum /ID# 124935
Rotterdam, Netherlands, 3015 CE
Haukeland University Hospital /ID# 124937
Bergen, Hordaland, Norway, 5021
Stavanger University Hospital /ID# 150177
Stavanger, Norway, 4068
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 124939
Rzeszów, Podkarpackie, Poland, 35-021
Centrum Onkologii Lukaszczyka /ID# 124938
Bydgoszcz, Poland, 85-796
Wojewodzki Szpital Zespolony /ID# 126998
Elblag, Poland, 82-300
Wojewodzkie Wielospecjalistycz /ID# 126999
Lodz, Poland, 93-509
Wojewodzki Szpital Specjalisty /ID# 127258
Wroclaw, Poland, 51-124
Centro Hospitalar De Vila Nova /ID# 126510
Vila Nova De Gaia, Porto, Portugal, 4434-502
Centro Hospitalar do Algarve /ID# 125298
Faro, Portugal, 8000-386
Centro Hospitalar Lisboa Norte, EPE /ID# 125299
Lisboa, Portugal, 1649-035
Unidade Local Saude Matosinhos /ID# 126511
Matosinhos, Portugal, 4464-513
IPO Porto FG, EPE /ID# 125297
Porto, Portugal, 4200-072
Centro Hospitalar de Sao Joao, EPE /ID# 126508
Porto, Portugal, 4200-319
Puerto Rico
Ad-Vance Medical Research, LLC /ID# 126043
Ponce, Puerto Rico, 00717
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948
Craiova, Dolj, Romania, 200347
lnstitutul Oncologic Trestiore /ID# 124943
Bucharest, Romania, 022328
Spitalul Clinic Judetean de Urgenta /ID# 124945
Cluj, Romania, 400006
Oncomed SRL /ID# 127598
Timisoara, Romania, 300239
Russian Federation
Sverdlovsk Regional Oncology Center /ID# 130950
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
Kursk Regional Oncology Dispen /ID# 125936
Kursk, Tatarstan, Respublika, Russian Federation, 305035
archangel Clinical Oncology /ID# 126031
Arkhangelsk, Russian Federation, 163045
Altay Regional Oncologic Disp /ID# 127160
Barnaul, Russian Federation, 656049
Belgorod Oncology Dispensary /ID# 129315
Belgorod, Russian Federation, 308010
GBOU VPO Saratov State Med Uni /ID# 139395
Saratov, Russian Federation, 410012
LLC BioEq Ltd. /ID# 134529
St. Petersburg, Russian Federation, 197342
Siberian State Med Uni /ID# 127161
Tomsk, Russian Federation, 634050
Volgograd Reg Onc Disp #3 /ID# 124952
Volzhsky, Russian Federation, 404130
National University Hospital /ID# 125315
Singapore, Singapore, 119074
Gleneagles Medical Centre /ID# 125300
Singapore, Singapore, 258499
Johns Hopkins Singapore IMC /ID# 125316
Singapore, Singapore, 308433
South Africa
GVI Oncology /ID# 125321
Port Elizabeth, Eastern Cape, South Africa, 6006
Universitas Annexe /ID# 128499
Bloemfontein, Free State, South Africa, 9320
Medical Oncology Ctr Rosebank /ID# 125322
Johannesburg, Gauteng, South Africa, 2196
Sandton Oncology Centre /ID# 125323
Johannesburg, Gauteng, South Africa, 2199
Mary Potter Oncology Centre /ID# 133269
Pretoria, Gauteng, South Africa, 0181
The Oncology Centre /ID# 126104
Durban, Kwazulu-Natal, South Africa, 4091
Netcare Oncology Intervent Ctr /ID# 125320
Cape Town, Western Cape, South Africa, 7460
Cancercare Outeniqua Oncology Unit /ID# 125319
George, Western Cape, South Africa, 6530
Hosp Santa Creu i Sant Pau /ID# 124963
Barcelona, Spain, 08026
Hospital General Universitario Gregorio Maranon /ID# 124962
Madrid, Spain, 28007
Hosp Univ Madrid Sanchinarro /ID# 124960
Madrid, Spain, 28050
Hosp Uni Virgen de la Victoria /ID# 124961
Malaga, Spain, 29010
Hosp Clin Univ de Valencia /ID# 124959
Valencia, Spain, 46010
Skanes Universitetssjukhus /ID# 124966
Malmö, Skane Lan, Sweden, 214 28
Sahlgrenska University Hosp /ID# 124965
Goteborg, Sweden, 413 45
Karolinska Univ Sjukhuset /ID# 124964
Solna, Sweden, 17176
Norrlands Universitetssjukhus /ID# 124967
Umeå, Sweden, 90185
Uppsala University Hospital /ID# 126512
Uppsala, Sweden, 75185
National Taiwan Univ Hosp /ID# 125324
Taipei City, Taipei, Taiwan, 10002
Kaohsiung Medical University /ID# 125575
Kaohsiung, Taiwan, 80708
Hacettepe University Medical Faculty /ID# 125336
Ankara, Turkey, 06100
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi /ID# 125337
Ankara, Turkey, 62000
Akdeniz University Medical Fac /ID# 125339
Antalya, Turkey, 07059
Bezmi alem Vakif Universitesi /ID# 127901
Istanbul, Turkey, 34093
Istanbul University Istanbul Medical Faculty /ID# 145144
Istanbul, Turkey, 34093
Cherkassy Regional Onc Ctr /ID# 124970
Cherkasy, Ukraine, 18000
City Multi-Field Clin Hosp #4 /ID# 124968
Dnipropetrovsk, Ukraine, 49102
Kharkiv Regional Clinical Onco /ID# 124972
Kharkiv, Ukraine, 61070
Kryorizskiy Oncology Dispensa /ID# 129806
Kryvyi Rih, Ukraine, 50048
Lviv State Onc Local Treatment /ID# 124974
Lviv, Ukraine, 79031
Poltava Regional Clinical Onco /ID# 124969
Poltava, Ukraine, 36011
Zaporizhzhia Med. Academy MOH /ID# 129800
Zaporizhia, Ukraine, 69040
United Kingdom
University of Birmingham /ID# 125342
Birmingham, United Kingdom, B15 2TT
Bristol Haematology and Onc Ct /ID# 128343
Bristol, United Kingdom, BS2 8ED
Castle Hill Hospital /ID# 133030
Cottingham, United Kingdom, HU16 5JQ
Nottingham Univ Hospitals NHS /ID# 125340
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie 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: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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