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A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02032277
Collaborator
German Breast Group (Other), NSABP Foundation Inc (Other), Grupo Español de Investigación del Cáncer de Mama (Other), US Oncology Research (Industry)
634
Enrollment
158
Locations
3
Arms
79.4
Actual Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
634 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)
Actual Study Start Date :
Apr 2, 2014
Actual Primary Completion Date :
Mar 18, 2016
Actual Study Completion Date :
Nov 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A

Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

Drug: Cyclophosphamide
Cyclophosphamide

Drug: Doxorubicin
Doxorubicin

Drug: Paclitaxel
Paclitaxel

Drug: Carboplatin
Carboplatin

Drug: Veliparib
Veliparib
Other Names:
  • ABT-888

    		•
    Placebo Comparator: Arm C

    Placebo + placebo + paclitaxel followed by AC.

    Drug: Cyclophosphamide
    Cyclophosphamide

    Drug: Placebo
    Placebo for Carboplatin

    Drug: Doxorubicin
    Doxorubicin

    Drug: Paclitaxel
    Paclitaxel

    Drug: Placebo
    Placebo for Veliparib
    Placebo Comparator: Arm B

    Placebo + carboplatin + paclitaxel followed by AC

    Drug: Cyclophosphamide
    Cyclophosphamide

    Drug: Doxorubicin
    Doxorubicin

    Drug: Paclitaxel
    Paclitaxel

    Drug: Carboplatin
    Carboplatin

    Drug: Placebo
    Placebo for Veliparib

    Outcome Measures

    Primary Outcome Measures

    1. Pathological Complete Response (pCR). [At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).]

      Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.

    Secondary Outcome Measures

    1. Event Free Survival (EFS) [Up to 4 years from the date of definitive surgery.]

      EFS will be defined as the time from random assignment to documentation of the first of the following events: discontinuation of study therapy due to protocol-defined progression prior to surgery; local, regional, or distant recurrence of breast cancer following curative surgery; a new breast cancer; another new onset malignancy; or death as a result of any cause.

    2. Overall Survival (OS) [Up to 4 years from the date of definitive surgery.]

      OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.

    3. Rate of eligibility for breast conservation after therapy (BCR). [At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).]

      Whether a subject is eligible for breast conserving surgery for whom mastectomy was planned at diagnosis will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.

    2. Documented Breast Cancer Gene (BRCA) germline mutation testing.

    3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.

    4. ECOG Performance status of 0 to 1.

    5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

    Exclusion Criteria:

    1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.

    2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.

    3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.

    4. A history of seizure within 12 months prior to study entry.

    5. Pre-existing neuropathy from any cause in excess of Grade 1.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scottsdale Healthcare /ID# 120473 Scottsdale Arizona United States 85258-4566
    2 Mayo Clinic - Scottsdale /ID# 139932 Scottsdale Arizona United States 85259
    3 Arizona Oncology Associates, PC-HOPE /ID# 126137 Tucson Arizona United States 85711-2701
    4 Usc /Id# 123310 Los Angeles California United States 90033
    5 Pacific Cancer Care /ID# 120476 Salinas California United States 93901
    6 Sharp Memorial Hospital /ID# 119861 San Diego California United States 92123
    7 Stanford University School of Med /ID# 130316 Stanford California United States 94305-2200
    8 Cedars-Sinai Medical Center - West Hollywood /ID# 137275 West Hollywood California United States 90048
    9 Christiana Care Health Service /ID# 137823 Newark Delaware United States 19713
    10 Florida Cancer Specialists - Fort Myers /ID# 121835 Fort Myers Florida United States 33916
    11 Florida Cancer Specialists - Fort Myers /ID# 126379 Fort Myers Florida United States 33916
    12 Mayo Clinic /ID# 132349 Jacksonville Florida United States 32224
    13 Mount Sinai Comp Cancer Ctr /ID# 133008 Miami Florida United States 33140
    14 Miami Cancer Institute - Baptist Health South Florida /ID# 126145 Miami Florida United States 33176
    15 UF Health Cancer Center /ID# 141589 Orlando Florida United States 32806
    16 Moffitt Cancer Center /ID# 124063 Tampa Florida United States 33612-9416
    17 University of Illinois - Chicago /ID# 134329 Chicago Illinois United States 60607
    18 Northwestern University Feinberg School of Medicine /ID# 133848 Chicago Illinois United States 60611-2927
    19 University of Chicago DCAM /ID# 120467 Chicago Illinois United States 60637-1443
    20 Loyola University Medical Ctr /ID# 120455 Maywood Illinois United States 60153
    21 OSF St. Anthony Medical Center /ID# 139424 Rockford Illinois United States 61108
    22 Indiana Univ School Medicine /ID# 118215 Indianapolis Indiana United States 46202
    23 Community Rgnal Cancer Care N /ID# 120456 Indianapolis Indiana United States 46256
    24 Horizon Oncology Research Center /ID# 116815 Lafayette Indiana United States 47905
    25 Cancer Center of Kansas /ID# 134720 Wichita Kansas United States 67214
    26 Univ Maryland School Medicine /ID# 119235 Baltimore Maryland United States 21201
    27 St. Joseph Mercy Hospital /ID# 135875 Ypsilanti Michigan United States 48106
    28 Minnesota Oncology Hematology, PA /ID# 126144 Minneapolis Minnesota United States 55404
    29 St. Lukes Cancer Institute /ID# 118775 Kansas City Missouri United States 64111-5905
    30 Comprehensive Cancer Ctrs Neva /ID# 126136 Las Vegas Nevada United States 89169
    31 Solinksy Center for Cancer Care /ID# 131970 Manchester New Hampshire United States 03103
    32 Rutgers Cancer Institute of NJ /ID# 120477 New Brunswick New Jersey United States 08903
    33 Columbia Univ Medical Center /ID# 141588 New York New York United States 10032-3725
    34 Hope Womens Cancer Centers /ID# 119179 Asheville North Carolina United States 28816
    35 Univ NC Chapel Hill /ID# 132893 Chapel Hill North Carolina United States 27514-4220
    36 Univ NC Chapel Hill /ID# 147695 Chapel Hill North Carolina United States 27514-4220
    37 Novant Health Oncology Special /ID# 139890 Winston-Salem North Carolina United States 27103
    38 Sanford Roger Maris Cancer Cen /ID# 132394 Fargo North Dakota United States 58102
    39 Oncology Hematology Care, Inc - Blue Ash /ID# 120478 Cincinnati Ohio United States 45252
    40 University Hospitals Case Medical Center /ID# 141691 Cleveland Ohio United States 44106
    41 Fairview Hospital /ID# 141626 Cleveland Ohio United States 44111
    42 Cleveland Clinic Main Campus /ID# 126378 Cleveland Ohio United States 44195
    43 The Ohio State University /ID# 141587 Columbus Ohio United States 43210
    44 Lehigh Valley Health Network /ID# 133372 Allentown Pennsylvania United States 18103
    45 Guthrie Medical Group, PC /ID# 124397 Sayre Pennsylvania United States 18840
    46 Women and Infants Hospital /ID# 123476 Providence Rhode Island United States 02905
    47 Avera Cancer Institute /ID# 120466 Sioux Falls South Dakota United States 57105
    48 Tennessee Oncology, PLLC /ID# 124566 Nashville Tennessee United States 37203
    49 Texas Oncology - Bedford /ID# 126135 Bedford Texas United States 76022
    50 Texas Oncology - Medical City Dallas /ID# 126140 Dallas Texas United States 75230
    51 Texas Oncology - Medical City Dallas /ID# 126141 Dallas Texas United States 75230
    52 UT Southwestern Medical Center /ID# 133849 Dallas Texas United States 75390-7208
    53 The Ctr for Cancer and Blood D /ID# 120479 Fort Worth Texas United States 76104
    54 Texas Oncology - Memorial City /ID# 126139 Houston Texas United States 77024
    55 Texas Oncology - Plano East /ID# 126143 Plano Texas United States 75075
    56 Texas Oncology - Tyler /ID# 126142 Tyler Texas United States 75702
    57 University of Utah /ID# 118677 Salt Lake City Utah United States 84112-5500
    58 University of Virginia /ID# 122975 Charlottesville Virginia United States 22908
    59 Virginia Commonwealth Univ /ID# 141586 Richmond Virginia United States 23219
    60 Virginia Oncology Associates /ID# 127260 Virginia Beach Virginia United States 23456
    61 Univ of Wisconsin Hosp/Clinics /ID# 120457 Madison Wisconsin United States 53792-0001
    62 The Tweed Hospital /ID# 120235 Tweed Heads New South Wales Australia 2485
    63 Cabrini Health /ID# 120236 Malvern Victoria Australia 3144
    64 Royal Melbourne Hospital /ID# 127717 Parkville Victoria Australia 3050
    65 Western Health Sunshine Hosp. /ID# 120715 St. Albans Victoria Australia 3021
    66 Fiona Stanley Hospital /ID# 120716 Murdoch Western Australia Australia 6150
    67 St. John of God Hosp - Murdoch /ID# 131788 Murdoch Western Australia Australia 6150
    68 St. John of God Subiaco Hosp /ID# 120717 Subiaco Western Australia Australia 6008
    69 Cliniques Universitaires Saint Luc /ID# 120719 Woluwe-Saint-Lambert Bruxelles-Capitale Belgium 1200
    70 Grand Hôpital de Charleroi /ID# 116678 Charleroi Hainaut Belgium 6000
    71 CHU Brugmann /ID# 120376 Brussels Belgium 1020
    72 UZ Antwerp /ID# 120720 Edegem Belgium 2650
    73 AZ Groeninge /ID# 120718 Kortrijk Belgium 8500
    74 CHU UCL Namur /ID# 116677 Namur Belgium 5000
    75 Sunnybrook Health Sciences Ctr /ID# 123312 Toronto Ontario Canada M4N 3M5
    76 Jewish General Hospital /ID# 141629 Montreal Quebec Canada H3T 1E2
    77 CHUM - Notre-Dame Hospital /ID# 141694 Montréal Quebec Canada H2X 0A9
    78 CHUQ-Hospital St. Sacrement /ID# 141619 Quebec City Quebec Canada G1S 4L8
    79 Fakultni Nemocnice Olomouc /ID# 120725 Olomouc Olomoucky Kraj Czechia 779 00
    80 Masarykuv onkologikcy ustav /ID# 120726 Brno Czechia 656 53
    81 FN Hradec Kralove /ID# 120596 Hradec Kralove Czechia 500 05
    82 Hopital Universitaire Purpan /ID# 120731 Toulouse Haute-Garonne France 31059
    83 Centre Oscar Lambret /ID# 119958 Lille Hauts-de-France France 59020
    84 Institut Curie /ID# 116679 Paris CEDEX 05 Ile-de-France France 75248
    85 Centre Leon Berard /ID# 120740 Lyon CEDEX 08 Rhone France 69373
    86 Jean Perrin Centre /ID# 125277 Clermont Ferrand France 63011
    87 Hosp European, Georges Pompid /ID# 120736 Paris France 75015
    88 Hopital Rene Huguenin /ID# 120729 Saint-cloud France 92210
    89 Universitaetsklinikum Schleswig-Holstein /ID# 133454 Kiel Schleswig-Holstein Germany 24105
    90 Universitaetsklinikum Ulm /ID# 133453 Ulm Thueringen Germany 89081
    91 Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472 Augsburg Germany 86150
    92 Helios Klinikum Berlin Buch /ID# 133465 Berlin Germany 13125
    93 Studiengesellschaft Onk Bielef /ID# 133471 Bielefeld Germany 33604
    94 Klinikum Bremen Mitte gGmbH /ID# 132875 Bremen Germany 28205
    95 St. Johannes Hospital /ID# 133478 Dortmund Germany 44137
    96 Kliniken Esslingen /ID# 133475 Esslingen Germany 73730
    97 Klinikum Frankfurt Hoechst /ID# 145301 Frankfurt Germany 65929
    98 Wilke/Wagner/Petzoldt, Fuerth /ID# 133481 Fürth Germany 90766
    99 Evangelisches Krankenhaus /ID# 133457 Gelsenkirchen Germany 45879
    100 Elisabeth Krankenhaus /ID# 133461 Kassel Germany 34117
    101 St. Vincenz Krankenhaus /ID# 133466 Limburg Germany 65549
    102 Onk Zentrum am Rotkreuz /ID# 133482 Munich Germany 80634
    103 Klinikum recht der Isar der TU /ID# 133449 Munich Germany 80802
    104 Sana Klinikum Offenbach /ID# 133455 Offenbach Germany 63069
    105 Leopoldina-Krankenhaus /ID# 133484 Schweinfurt Germany 97422
    106 Johanniter-Krankenhaus Genthin /ID# 133463 Stendal Germany 39576
    107 St. Josefs-Hospital /ID# 133464 Wiesbaden Germany 65189
    108 Marienhospital Witten /ID# 133470 Witten Germany 58452
    109 National Institute of Oncology /ID# 120828 Budapest Hungary 1122
    110 Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834 Budapest Hungary 1134
    111 Uzsoki Utcai Korhaz /ID# 120825 Budapest Hungary 1145
    112 Debreceni Egyetem Klinikai Kozpont /ID# 116681 Debrecen Hungary 4032
    113 Petz Aladar Megyei Oktato Korh /ID# 120835 Gyor Hungary 9023
    114 Bacs-Kiskun Megyei Korhaz /ID# 120833 Kecskemét Hungary 6000
    115 BAZ Megyei E.O. Korhaz /ID# 122215 Miskolc Hungary 3526
    116 University of Szeged /ID# 120823 Szeged Hungary 6720
    117 Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818 Szolnok Hungary 5004
    118 A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855 Bologna Emilia-Romagna Italy 40138
    119 Misericordia General Hospital /ID# 119536 Grosseto Italy 58100
    120 IRCCS-I.R.S.T. srl Meldola /ID# 120255 Meldola Italy 47014
    121 Istituto Europeo di Oncologia /ID# 120845 Milan Italy 20141
    122 IRCCS Fondazione Salva Maugeri /ID# 120848 Pavia Italy 27100
    123 National Cancer Center /ID# 119525 Goyang Gyeonggido Korea, Republic of 10408
    124 Ajou University Hospital /ID# 118856 Suwon-si Gyeonggido Korea, Republic of 16499
    125 Kyungpook National University Chilgok Hospital /ID# 118855 Daegu Seoul Teugbyeolsi Korea, Republic of 41404
    126 Severance Hospital /ID# 116699 Seoul Seoul Teugbyeolsi Korea, Republic of 03722
    127 Samsung Medical Center /ID# 119276 Seoul Seoul Teugbyeolsi Korea, Republic of 06351
    128 Korea University Anam Hospital /ID# 118857 Seoul Korea, Republic of 02841
    129 Seoul National University Hospital /ID# 116698 Seoul Korea, Republic of 03080
    130 Asan Medical Center /ID# 116696 Seoul Korea, Republic of 05505
    131 Vrije Universiteit Medisch Centrum /ID# 126302 Amsterdam Netherlands 1081 HV
    132 Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944 Moscow Moskva Russian Federation 115478
    133 Kursk Regional Oncology Dispen /ID# 116688 Kursk Tatarstan, Respublika Russian Federation 305035
    134 archangel Clinical Oncology /ID# 120935 Arkhangelsk Russian Federation 163045
    135 Medical Radiological Res Ctr /ID# 124017 Obninsk Russian Federation 249036
    136 Pyatigorsk Oncology Dispensary /ID# 120945 Pyatigorsk Russian Federation 357502
    137 Leningrad Reg Onc Dispensery /ID# 120938 St. Petersburg Russian Federation 188663
    138 Birch A Healthcare /ID# 116695 St. Petersburg Russian Federation 197183
    139 Hospital Universitario A Coruña - CHUAC /ID# 135108 A Coruña A Coruna Spain 15006
    140 Hospital Universitario Germans Trias i Pujol /ID# 135112 Badalona Barcelona Spain 08916
    141 Hospital General Universitario Alicante /ID# 135115 Alicante Spain 03010
    142 Hospital Parc de Salut del Mar /ID# 135110 Barcelona Spain 08003
    143 Hospital Santa Creu i Sant Pau /ID# 145400 Barcelona Spain 08041
    144 Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979 Lleida Spain 25198
    145 Hospital Universitario Ramon y Cajal /ID# 135113 Madrid Spain 28034
    146 Hospital Clinico Universitario San Carlos /ID# 119959 Madrid Spain 28040
    147 Hospital Universitario Virgen del Rocio /ID# 135114 Sevilla Spain 41013
    148 Fundacion Instituto Valenciano Oncologia IVO /ID# 135116 Valencia Spain 46009
    149 Hospital Clinico Universitario de Valencia /ID# 123076 Valencia Spain 46010
    150 Hospital General Universitario de Valencia /ID# 135111 Valencia Spain 46014
    151 Hospital Universitario Miguel Servet /ID# 119195 Zaragoza Spain 50009
    152 National Taiwan Univ Hosp /ID# 122895 Taipei City Taipei Taiwan 10002
    153 Changhua Christian Hospital /ID# 119085 Changhua County Taiwan 50006
    154 Chi Mei Hospital - Liouying /ID# 120982 Tainan City Taiwan 73657
    155 Univ Hosp Bristol NHS Foundati /ID# 120989 Bristol United Kingdom BS2 8EG
    156 Charing Cross Hospital /ID# 120990 London United Kingdom W6 8RF
    157 Nottingham Univ Hospitals NHS /ID# 122218 Nottingham United Kingdom NG5 1PB
    158 Royal Stoke Univ Hospital /ID# 120984 Stoke on Trent United Kingdom ST4 6QG

    Sponsors and Collaborators

    • AbbVie
    • German Breast Group
    • NSABP Foundation Inc
    • Grupo Español de Investigación del Cáncer de Mama
    • US Oncology Research

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02032277
    Other Study ID Numbers:
    • M14-011
    • 2013-002377-21
    First Posted:
    Jan 10, 2014
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Oncology
    Triple negative breast cancer
    German Breast Group - GBG 81
    United States Oncology - 12152
    National Surgical Adjuvant Breast and Bowel Project - B-56-I
    Alliance - AFT-04
    Grupo Español de Investigación en Cáncer de Mama - GEICAM/2014-02
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms
    Paclitaxel
    Cyclophosphamide
    Carboplatin
    Doxorubicin
    Veliparib

    Study Results

    No Results Posted as of Jan 20, 2021