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
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)
2 other identifiers
interventional
634
15 countries
158
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
Longer than P75 for phase_3
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
April 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2020
CompletedJanuary 20, 2021
January 1, 2021
2 years
December 13, 2013
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological Complete Response (pCR).
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.
At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).
Secondary Outcomes (3)
Event Free Survival (EFS)
Up to 4 years from the date of definitive surgery.
Overall Survival (OS)
Up to 4 years from the date of definitive surgery.
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).
Study Arms (3)
Arm A
ACTIVE COMPARATORVeliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
Arm C
PLACEBO COMPARATORPlacebo + placebo + paclitaxel followed by AC.
Arm B
PLACEBO COMPARATORPlacebo + carboplatin + paclitaxel followed by AC
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Documented Breast Cancer Gene (BRCA) germline mutation testing.
- Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
- ECOG Performance status of 0 to 1.
- 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.
You may not qualify if:
- Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
- Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
- 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.
- A history of seizure within 12 months prior to study entry.
- Pre-existing neuropathy from any cause in excess of Grade 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- GBG Forschungs GmbHcollaborator
- NSABP Foundation Inccollaborator
- Grupo Español de Investigación del Cáncer de Mamacollaborator
- US Oncology Researchcollaborator
Study Sites (158)
Scottsdale Healthcare /ID# 120473
Scottsdale, Arizona, 85258-4566, United States
Mayo Clinic - Scottsdale /ID# 139932
Scottsdale, Arizona, 85259, United States
Arizona Oncology Associates, PC-HOPE /ID# 126137
Tucson, Arizona, 85711-2701, United States
Usc /Id# 123310
Los Angeles, California, 90033, United States
Pacific Cancer Care /ID# 120476
Salinas, California, 93901, United States
Sharp Memorial Hospital /ID# 119861
San Diego, California, 92123, United States
Stanford University School of Med /ID# 130316
Stanford, California, 94305-2200, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 137275
West Hollywood, California, 90048, United States
Christiana Care Health Service /ID# 137823
Newark, Delaware, 19713, United States
Florida Cancer Specialists - Fort Myers /ID# 121835
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists - Fort Myers /ID# 126379
Fort Myers, Florida, 33916, United States
Mayo Clinic /ID# 132349
Jacksonville, Florida, 32224, United States
Mount Sinai Comp Cancer Ctr /ID# 133008
Miami, Florida, 33140, United States
Miami Cancer Institute - Baptist Health South Florida /ID# 126145
Miami, Florida, 33176, United States
UF Health Cancer Center /ID# 141589
Orlando, Florida, 32806, United States
Moffitt Cancer Center /ID# 124063
Tampa, Florida, 33612-9416, United States
University of Illinois - Chicago /ID# 134329
Chicago, Illinois, 60607, United States
Northwestern University Feinberg School of Medicine /ID# 133848
Chicago, Illinois, 60611-2927, United States
University of Chicago DCAM /ID# 120467
Chicago, Illinois, 60637-1443, United States
Loyola University Medical Ctr /ID# 120455
Maywood, Illinois, 60153, United States
OSF St. Anthony Medical Center /ID# 139424
Rockford, Illinois, 61108, United States
Indiana Univ School Medicine /ID# 118215
Indianapolis, Indiana, 46202, United States
Community Rgnal Cancer Care N /ID# 120456
Indianapolis, Indiana, 46256, United States
Horizon Oncology Research Center /ID# 116815
Lafayette, Indiana, 47905, United States
Cancer Center of Kansas /ID# 134720
Wichita, Kansas, 67214, United States
Univ Maryland School Medicine /ID# 119235
Baltimore, Maryland, 21201, United States
St. Joseph Mercy Hospital /ID# 135875
Ypsilanti, Michigan, 48106, United States
Minnesota Oncology Hematology, PA /ID# 126144
Minneapolis, Minnesota, 55404, United States
St. Lukes Cancer Institute /ID# 118775
Kansas City, Missouri, 64111-5905, United States
Comprehensive Cancer Ctrs Neva /ID# 126136
Las Vegas, Nevada, 89169, United States
Solinksy Center for Cancer Care /ID# 131970
Manchester, New Hampshire, 03103, United States
Rutgers Cancer Institute of NJ /ID# 120477
New Brunswick, New Jersey, 08903, United States
Columbia Univ Medical Center /ID# 141588
New York, New York, 10032-3725, United States
Hope Womens Cancer Centers /ID# 119179
Asheville, North Carolina, 28816, United States
Univ NC Chapel Hill /ID# 132893
Chapel Hill, North Carolina, 27514-4220, United States
Univ NC Chapel Hill /ID# 147695
Chapel Hill, North Carolina, 27514-4220, United States
Novant Health Oncology Special /ID# 139890
Winston-Salem, North Carolina, 27103, United States
Sanford Roger Maris Cancer Cen /ID# 132394
Fargo, North Dakota, 58102, United States
Oncology Hematology Care, Inc - Blue Ash /ID# 120478
Cincinnati, Ohio, 45252, United States
University Hospitals Case Medical Center /ID# 141691
Cleveland, Ohio, 44106, United States
Fairview Hospital /ID# 141626
Cleveland, Ohio, 44111, United States
Cleveland Clinic Main Campus /ID# 126378
Cleveland, Ohio, 44195, United States
The Ohio State University /ID# 141587
Columbus, Ohio, 43210, United States
Lehigh Valley Health Network /ID# 133372
Allentown, Pennsylvania, 18103, United States
Guthrie Medical Group, PC /ID# 124397
Sayre, Pennsylvania, 18840, United States
Women and Infants Hospital /ID# 123476
Providence, Rhode Island, 02905, United States
Avera Cancer Institute /ID# 120466
Sioux Falls, South Dakota, 57105, United States
Tennessee Oncology, PLLC /ID# 124566
Nashville, Tennessee, 37203, United States
Texas Oncology - Bedford /ID# 126135
Bedford, Texas, 76022, United States
Texas Oncology - Medical City Dallas /ID# 126140
Dallas, Texas, 75230, United States
Texas Oncology - Medical City Dallas /ID# 126141
Dallas, Texas, 75230, United States
UT Southwestern Medical Center /ID# 133849
Dallas, Texas, 75390-7208, United States
The Ctr for Cancer and Blood D /ID# 120479
Fort Worth, Texas, 76104, United States
Texas Oncology - Memorial City /ID# 126139
Houston, Texas, 77024, United States
Texas Oncology - Plano East /ID# 126143
Plano, Texas, 75075, United States
Texas Oncology - Tyler /ID# 126142
Tyler, Texas, 75702, United States
University of Utah /ID# 118677
Salt Lake City, Utah, 84112-5500, United States
University of Virginia /ID# 122975
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth Univ /ID# 141586
Richmond, Virginia, 23219, United States
Virginia Oncology Associates /ID# 127260
Virginia Beach, Virginia, 23456, United States
Univ of Wisconsin Hosp/Clinics /ID# 120457
Madison, Wisconsin, 53792-0001, United States
The Tweed Hospital /ID# 120235
Tweed Heads, New South Wales, 2485, Australia
Cabrini Health /ID# 120236
Malvern, Victoria, 3144, Australia
Royal Melbourne Hospital /ID# 127717
Parkville, Victoria, 3050, Australia
Western Health Sunshine Hosp. /ID# 120715
St Albans, Victoria, 3021, Australia
Fiona Stanley Hospital /ID# 120716
Murdoch, Western Australia, 6150, Australia
St. John of God Hosp - Murdoch /ID# 131788
Murdoch, Western Australia, 6150, Australia
St. John of God Subiaco Hosp /ID# 120717
Subiaco, Western Australia, 6008, Australia
Cliniques Universitaires Saint Luc /ID# 120719
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Grand Hôpital de Charleroi /ID# 116678
Charleroi, Hainaut, 6000, Belgium
CHU Brugmann /ID# 120376
Brussels, 1020, Belgium
UZ Antwerp /ID# 120720
Edegem, 2650, Belgium
AZ Groeninge /ID# 120718
Kortrijk, 8500, Belgium
CHU UCL Namur /ID# 116677
Namur, 5000, Belgium
Sunnybrook Health Sciences Ctr /ID# 123312
Toronto, Ontario, M4N 3M5, Canada
CHUM - Notre-Dame Hospital /ID# 141694
Montreal, Quebec, H2X 0A9, Canada
Jewish General Hospital /ID# 141629
Montreal, Quebec, H3T 1E2, Canada
CHUQ-Hospital St. Sacrement /ID# 141619
Québec, Quebec, G1S 4L8, Canada
Fakultni Nemocnice Olomouc /ID# 120725
Olomouc, Olomoucký kraj, 779 00, Czechia
Masarykuv onkologikcy ustav /ID# 120726
Brno, 656 53, Czechia
FN Hradec Kralove /ID# 120596
Hradec Králové, 500 05, Czechia
Hopital Universitaire Purpan /ID# 120731
Toulouse, Haute-Garonne, 31059, France
Centre Oscar Lambret /ID# 119958
Lille, Hauts-de-France, 59020, France
Centre Leon Berard /ID# 120740
Lyon, Rhone, 69373, France
Jean Perrin Centre /ID# 125277
Clermont-Ferrand, 63011, France
Hosp European, Georges Pompid /ID# 120736
Paris, 75015, France
Hopital Rene Huguenin /ID# 120729
Saint-Cloud, 92210, France
Institut Curie /ID# 116679
Paris, Île-de-France Region, 75248, France
Universitaetsklinikum Schleswig-Holstein /ID# 133454
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Ulm /ID# 133453
Ulm, Thuringia, 89081, Germany
Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472
Augsburg, 86150, Germany
Helios Klinikum Berlin Buch /ID# 133465
Berlin, 13125, Germany
Studiengesellschaft Onk Bielef /ID# 133471
Bielefeld, 33604, Germany
Klinikum Bremen Mitte gGmbH /ID# 132875
Bremen, 28205, Germany
St. Johannes Hospital /ID# 133478
Dortmund, 44137, Germany
Kliniken Esslingen /ID# 133475
Esslingen am Neckar, 73730, Germany
Klinikum Frankfurt Hoechst /ID# 145301
Frankfurt, 65929, Germany
Wilke/Wagner/Petzoldt, Fuerth /ID# 133481
Fürth, 90766, Germany
Evangelisches Krankenhaus /ID# 133457
Gelsenkirchen, 45879, Germany
Elisabeth Krankenhaus /ID# 133461
Kassel, 34117, Germany
St. Vincenz Krankenhaus /ID# 133466
Limburg, 65549, Germany
Onk Zentrum am Rotkreuz /ID# 133482
Munich, 80634, Germany
Klinikum recht der Isar der TU /ID# 133449
Munich, 80802, Germany
Sana Klinikum Offenbach /ID# 133455
Offenbach, 63069, Germany
Leopoldina-Krankenhaus /ID# 133484
Schweinfurt, 97422, Germany
Johanniter-Krankenhaus Genthin /ID# 133463
Stendal, 39576, Germany
St. Josefs-Hospital /ID# 133464
Wiesbaden, 65189, Germany
Marienhospital Witten /ID# 133470
Witten, 58452, Germany
National Institute of Oncology /ID# 120828
Budapest, 1122, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834
Budapest, 1134, Hungary
Uzsoki Utcai Korhaz /ID# 120825
Budapest, 1145, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 116681
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Korh /ID# 120835
Győr, 9023, Hungary
Bacs-Kiskun Megyei Korhaz /ID# 120833
Kecskemét, 6000, Hungary
BAZ Megyei E.O. Korhaz /ID# 122215
Miskolc, 3526, Hungary
University of Szeged /ID# 120823
Szeged, 6720, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818
Szolnok, 5004, Hungary
A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855
Bologna, Emilia-Romagna, 40138, Italy
Misericordia General Hospital /ID# 119536
Grosseto, 58100, Italy
IRCCS-I.R.S.T. srl Meldola /ID# 120255
Meldola, 47014, Italy
Istituto Europeo di Oncologia /ID# 120845
Milan, 20141, Italy
IRCCS Fondazione Salva Maugeri /ID# 120848
Pavia, 27100, Italy
Vrije Universiteit Medisch Centrum /ID# 126302
Amsterdam, 1081 HV, Netherlands
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944
Moscow, Moscow, 115478, Russia
Kursk Regional Oncology Dispen /ID# 116688
Kursk, Tatarstan, Respublika, 305035, Russia
archangel Clinical Oncology /ID# 120935
Arkhangelsk, 163045, Russia
Medical Radiological Res Ctr /ID# 124017
Obninsk, 249036, Russia
Pyatigorsk Oncology Dispensary /ID# 120945
Pyatigorsk, 357502, Russia
Leningrad Reg Onc Dispensery /ID# 120938
Saint Petersburg, 188663, Russia
Birch A Healthcare /ID# 116695
Saint Petersburg, 197183, Russia
National Cancer Center /ID# 119525
Goyang, Gyeonggido, 10408, South Korea
Ajou University Hospital /ID# 118856
Suwon, Gyeonggido, 16499, South Korea
Kyungpook National University Chilgok Hospital /ID# 118855
Daegu, Seoul Teugbyeolsi, 41404, South Korea
Severance Hospital /ID# 116699
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Samsung Medical Center /ID# 119276
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Korea University Anam Hospital /ID# 118857
Seoul, 02841, South Korea
Seoul National University Hospital /ID# 116698
Seoul, 03080, South Korea
Asan Medical Center /ID# 116696
Seoul, 05505, South Korea
Hospital Universitario A Coruña - CHUAC /ID# 135108
A Coruña, A Coruna, 15006, Spain
Hospital Universitario Germans Trias i Pujol /ID# 135112
Badalona, Barcelona, 08916, Spain
Hospital General Universitario Alicante /ID# 135115
Alicante, 03010, Spain
Hospital Parc de Salut del Mar /ID# 135110
Barcelona, 08003, Spain
Hospital Santa Creu i Sant Pau /ID# 145400
Barcelona, 08041, Spain
Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979
Lleida, 25198, Spain
Hospital Universitario Ramon y Cajal /ID# 135113
Madrid, 28034, Spain
Hospital Clinico Universitario San Carlos /ID# 119959
Madrid, 28040, Spain
Hospital Universitario Virgen del Rocio /ID# 135114
Seville, 41013, Spain
Fundacion Instituto Valenciano Oncologia IVO /ID# 135116
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia /ID# 123076
Valencia, 46010, Spain
Hospital General Universitario de Valencia /ID# 135111
Valencia, 46014, Spain
Hospital Universitario Miguel Servet /ID# 119195
Zaragoza, 50009, Spain
National Taiwan Univ Hosp /ID# 122895
Taipei City, Taipei, 10002, Taiwan
Changhua Christian Hospital /ID# 119085
Changhua County, 50006, Taiwan
Chi Mei Hospital - Liouying /ID# 120982
Tainan, 73657, Taiwan
Univ Hosp Bristol NHS Foundati /ID# 120989
Bristol, BS2 8EG, United Kingdom
Charing Cross Hospital /ID# 120990
London, W6 8RF, United Kingdom
Nottingham Univ Hospitals NHS /ID# 122218
Nottingham, NG5 1PB, United Kingdom
Royal Stoke Univ Hospital /ID# 120984
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (4)
Filho OM, Stover DG, Asad S, Ansell PJ, Watson M, Loibl S, Geyer CE Jr, Bae J, Collier K, Cherian M, O'Shaughnessy J, Untch M, Rugo HS, Huober JB, Golshan M, Sikov WM, von Minckwitz G, Rastogi P, Maag D, Wolmark N, Denkert C, Symmans WF. Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: A Secondary Analysis of the BrighTNess Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):603-608. doi: 10.1001/jamaoncol.2020.7310.
PMID: 33599688DERIVEDGolshan M, Loibl S, Wong SM, Houber JB, O'Shaughnessy J, Rugo HS, Wolmark N, McKee MD, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):e195410. doi: 10.1001/jamasurg.2019.5410. Epub 2020 Mar 18.
PMID: 31913413DERIVEDGolshan M, Wong SM, Loibl S, Huober JB, O'Shaughnessy J, Rugo HS, Wolmark N, Ansell P, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial. Eur J Surg Oncol. 2020 Feb;46(2):223-228. doi: 10.1016/j.ejso.2019.10.002. Epub 2019 Oct 5.
PMID: 31606288DERIVEDLoibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.
PMID: 29501363DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 13, 2013
First Posted
January 10, 2014
Study Start
April 2, 2014
Primary Completion
March 18, 2016
Study Completion
November 12, 2020
Last Updated
January 20, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
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.