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
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Registration Number
- NCT02032277
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 634
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Paclitaxel Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm A Cyclophosphamide Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm A Doxorubicin Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm C Placebo Placebo + placebo + paclitaxel followed by AC. Arm A Carboplatin Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm B Placebo Placebo + carboplatin + paclitaxel followed by AC Arm B Paclitaxel Placebo + carboplatin + paclitaxel followed by AC Arm A Veliparib Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm B Cyclophosphamide Placebo + carboplatin + paclitaxel followed by AC Arm C Cyclophosphamide Placebo + placebo + paclitaxel followed by AC. Arm C Doxorubicin Placebo + placebo + paclitaxel followed by AC. Arm C Paclitaxel Placebo + placebo + paclitaxel followed by AC. Arm B Doxorubicin Placebo + carboplatin + paclitaxel followed by AC Arm B Carboplatin Placebo + carboplatin + paclitaxel followed by AC
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
Trial Locations
- Locations (158)
Lehigh Valley Health Network /ID# 133372
🇺🇸Allentown, Pennsylvania, United States
Texas Oncology - Medical City Dallas /ID# 126141
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center /ID# 133849
🇺🇸Dallas, Texas, United States
Hope Womens Cancer Centers /ID# 119179
🇺🇸Asheville, North Carolina, United States
University of Chicago DCAM /ID# 120467
🇺🇸Chicago, Illinois, United States
Fairview Hospital /ID# 141626
🇺🇸Cleveland, Ohio, United States
The Ohio State University /ID# 141587
🇺🇸Columbus, Ohio, United States
Indiana Univ School Medicine /ID# 118215
🇺🇸Indianapolis, Indiana, United States
Community Rgnal Cancer Care N /ID# 120456
🇺🇸Indianapolis, Indiana, United States
Sharp Memorial Hospital /ID# 119861
🇺🇸San Diego, California, United States
Comprehensive Cancer Ctrs Neva /ID# 126136
🇺🇸Las Vegas, Nevada, United States
Universitaetsklinikum Schleswig-Holstein /ID# 133454
🇩🇪Kiel, Schleswig-Holstein, Germany
Tennessee Oncology, PLLC /ID# 124566
🇺🇸Nashville, Tennessee, United States
University of Utah /ID# 118677
🇺🇸Salt Lake City, Utah, United States
Cliniques Universitaires Saint Luc /ID# 120719
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
CHUQ-Hospital St. Sacrement /ID# 141619
🇨🇦Quebec City, Quebec, Canada
Debreceni Egyetem Klinikai Kozpont /ID# 116681
ðŸ‡ðŸ‡ºDebrecen, Hungary
Mayo Clinic - Scottsdale /ID# 139932
🇺🇸Scottsdale, Arizona, United States
AZ Groeninge /ID# 120718
🇧🇪Kortrijk, Belgium
CHU UCL Namur /ID# 116677
🇧🇪Namur, Belgium
CHUM - Notre-Dame Hospital /ID# 141694
🇨🇦Montréal, Quebec, Canada
Chi Mei Hospital - Liouying /ID# 120982
🇨🇳Tainan City, Taiwan
Jewish General Hospital /ID# 141629
🇨🇦Montreal, Quebec, Canada
Bacs-Kiskun Megyei Korhaz /ID# 120833
ðŸ‡ðŸ‡ºKecskemét, Hungary
BAZ Megyei E.O. Korhaz /ID# 122215
ðŸ‡ðŸ‡ºMiskolc, Hungary
archangel Clinical Oncology /ID# 120935
🇷🇺Arkhangelsk, Russian Federation
Avera Cancer Institute /ID# 120466
🇺🇸Sioux Falls, South Dakota, United States
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818
ðŸ‡ðŸ‡ºSzolnok, Hungary
St. Joseph Mercy Hospital /ID# 135875
🇺🇸Ypsilanti, Michigan, United States
Royal Melbourne Hospital /ID# 127717
🇦🇺Parkville, Victoria, Australia
Hospital Universitario Germans Trias i Pujol /ID# 135112
🇪🇸Badalona, Barcelona, Spain
IRCCS Fondazione Salva Maugeri /ID# 120848
🇮🇹Pavia, Italy
Cedars-Sinai Medical Center - West Hollywood /ID# 137275
🇺🇸West Hollywood, California, United States
Florida Cancer Specialists - Fort Myers /ID# 121835
🇺🇸Fort Myers, Florida, United States
Usc /Id# 123310
🇺🇸Los Angeles, California, United States
Northwestern University Feinberg School of Medicine /ID# 133848
🇺🇸Chicago, Illinois, United States
Christiana Care Health Service /ID# 137823
🇺🇸Newark, Delaware, United States
Arizona Oncology Associates, PC-HOPE /ID# 126137
🇺🇸Tucson, Arizona, United States
Stanford University School of Med /ID# 130316
🇺🇸Stanford, California, United States
OSF St. Anthony Medical Center /ID# 139424
🇺🇸Rockford, Illinois, United States
Florida Cancer Specialists - Fort Myers /ID# 126379
🇺🇸Fort Myers, Florida, United States
Rutgers Cancer Institute of NJ /ID# 120477
🇺🇸New Brunswick, New Jersey, United States
Sanford Roger Maris Cancer Cen /ID# 132394
🇺🇸Fargo, North Dakota, United States
Miami Cancer Institute - Baptist Health South Florida /ID# 126145
🇺🇸Miami, Florida, United States
Mayo Clinic /ID# 132349
🇺🇸Jacksonville, Florida, United States
University of Illinois - Chicago /ID# 134329
🇺🇸Chicago, Illinois, United States
Mount Sinai Comp Cancer Ctr /ID# 133008
🇺🇸Miami, Florida, United States
Cancer Center of Kansas /ID# 134720
🇺🇸Wichita, Kansas, United States
Fiona Stanley Hospital /ID# 120716
🇦🇺Murdoch, Western Australia, Australia
St. John of God Hosp - Murdoch /ID# 131788
🇦🇺Murdoch, Western Australia, Australia
University Hospitals Case Medical Center /ID# 141691
🇺🇸Cleveland, Ohio, United States
Institut Curie /ID# 116679
🇫🇷Paris CEDEX 05, Ile-de-France, France
Jean Perrin Centre /ID# 125277
🇫🇷Clermont Ferrand, France
Fakultni Nemocnice Olomouc /ID# 120725
🇨🇿Olomouc, Olomoucky Kraj, Czechia
Cleveland Clinic Main Campus /ID# 126378
🇺🇸Cleveland, Ohio, United States
Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472
🇩🇪Augsburg, Germany
FN Hradec Kralove /ID# 120596
🇨🇿Hradec Kralove, Czechia
Minnesota Oncology Hematology, PA /ID# 126144
🇺🇸Minneapolis, Minnesota, United States
Columbia Univ Medical Center /ID# 141588
🇺🇸New York, New York, United States
Women and Infants Hospital /ID# 123476
🇺🇸Providence, Rhode Island, United States
Univ Maryland School Medicine /ID# 119235
🇺🇸Baltimore, Maryland, United States
Solinksy Center for Cancer Care /ID# 131970
🇺🇸Manchester, New Hampshire, United States
Texas Oncology - Bedford /ID# 126135
🇺🇸Bedford, Texas, United States
Oncology Hematology Care, Inc - Blue Ash /ID# 120478
🇺🇸Cincinnati, Ohio, United States
Texas Oncology - Memorial City /ID# 126139
🇺🇸Houston, Texas, United States
The Tweed Hospital /ID# 120235
🇦🇺Tweed Heads, New South Wales, Australia
St. John of God Subiaco Hosp /ID# 120717
🇦🇺Subiaco, Western Australia, Australia
Cabrini Health /ID# 120236
🇦🇺Malvern, Victoria, Australia
Western Health Sunshine Hosp. /ID# 120715
🇦🇺St. Albans, Victoria, Australia
UZ Antwerp /ID# 120720
🇧🇪Edegem, Belgium
Grand Hôpital de Charleroi /ID# 116678
🇧🇪Charleroi, Hainaut, Belgium
CHU Brugmann /ID# 120376
🇧🇪Brussels, Belgium
Masarykuv onkologikcy ustav /ID# 120726
🇨🇿Brno, Czechia
Hopital Universitaire Purpan /ID# 120731
🇫🇷Toulouse, Haute-Garonne, France
Centre Leon Berard /ID# 120740
🇫🇷Lyon CEDEX 08, Rhone, France
Klinikum Frankfurt Hoechst /ID# 145301
🇩🇪Frankfurt, Germany
Hosp European, Georges Pompid /ID# 120736
🇫🇷Paris, France
Universitaetsklinikum Ulm /ID# 133453
🇩🇪Ulm, Thueringen, Germany
St. Johannes Hospital /ID# 133478
🇩🇪Dortmund, Germany
Studiengesellschaft Onk Bielef /ID# 133471
🇩🇪Bielefeld, Germany
Leopoldina-Krankenhaus /ID# 133484
🇩🇪Schweinfurt, Germany
Petz Aladar Megyei Oktato Korh /ID# 120835
ðŸ‡ðŸ‡ºGyor, Hungary
Klinikum recht der Isar der TU /ID# 133449
🇩🇪Munich, Germany
Istituto Europeo di Oncologia /ID# 120845
🇮🇹Milan, Italy
Johanniter-Krankenhaus Genthin /ID# 133463
🇩🇪Stendal, Germany
Ajou University Hospital /ID# 118856
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
Kyungpook National University Chilgok Hospital /ID# 118855
🇰🇷Daegu, Seoul Teugbyeolsi, Korea, Republic of
St. Josefs-Hospital /ID# 133464
🇩🇪Wiesbaden, Germany
Severance Hospital /ID# 116699
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
National Institute of Oncology /ID# 120828
ðŸ‡ðŸ‡ºBudapest, Hungary
Fundacion Instituto Valenciano Oncologia IVO /ID# 135116
🇪🇸Valencia, Spain
Hospital Universitario Virgen del Rocio /ID# 135114
🇪🇸Sevilla, Spain
Korea University Anam Hospital /ID# 118857
🇰🇷Seoul, Korea, Republic of
Univ Hosp Bristol NHS Foundati /ID# 120989
🇬🇧Bristol, United Kingdom
Asan Medical Center /ID# 116696
🇰🇷Seoul, Korea, Republic of
National Taiwan Univ Hosp /ID# 122895
🇨🇳Taipei City, Taipei, Taiwan
Vrije Universiteit Medisch Centrum /ID# 126302
🇳🇱Amsterdam, Netherlands
Medical Radiological Res Ctr /ID# 124017
🇷🇺Obninsk, Russian Federation
Royal Stoke Univ Hospital /ID# 120984
🇬🇧Stoke on Trent, United Kingdom
Hospital Santa Creu i Sant Pau /ID# 145400
🇪🇸Barcelona, Spain
Seoul National University Hospital /ID# 116698
🇰🇷Seoul, Korea, Republic of
Changhua Christian Hospital /ID# 119085
🇨🇳Changhua County, Taiwan
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944
🇷🇺Moscow, Moskva, Russian Federation
Kursk Regional Oncology Dispen /ID# 116688
🇷🇺Kursk, Tatarstan, Respublika, Russian Federation
Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979
🇪🇸Lleida, Spain
Pyatigorsk Oncology Dispensary /ID# 120945
🇷🇺Pyatigorsk, Russian Federation
Birch A Healthcare /ID# 116695
🇷🇺St. Petersburg, Russian Federation
Hospital Parc de Salut del Mar /ID# 135110
🇪🇸Barcelona, Spain
Charing Cross Hospital /ID# 120990
🇬🇧London, United Kingdom
Hospital Universitario Ramon y Cajal /ID# 135113
🇪🇸Madrid, Spain
Hospital Clinico Universitario San Carlos /ID# 119959
🇪🇸Madrid, Spain
Hospital Universitario Miguel Servet /ID# 119195
🇪🇸Zaragoza, Spain
Hopital Rene Huguenin /ID# 120729
🇫🇷Saint-cloud, France
Nottingham Univ Hospitals NHS /ID# 122218
🇬🇧Nottingham, United Kingdom
Evangelisches Krankenhaus /ID# 133457
🇩🇪Gelsenkirchen, Germany
Elisabeth Krankenhaus /ID# 133461
🇩🇪Kassel, Germany
Kliniken Esslingen /ID# 133475
🇩🇪Esslingen, Germany
St. Vincenz Krankenhaus /ID# 133466
🇩🇪Limburg, Germany
Hospital General Universitario de Valencia /ID# 135111
🇪🇸Valencia, Spain
Texas Oncology - Plano East /ID# 126143
🇺🇸Plano, Texas, United States
The Ctr for Cancer and Blood D /ID# 120479
🇺🇸Fort Worth, Texas, United States
Guthrie Medical Group, PC /ID# 124397
🇺🇸Sayre, Pennsylvania, United States
Texas Oncology - Medical City Dallas /ID# 126140
🇺🇸Dallas, Texas, United States
Moffitt Cancer Center /ID# 124063
🇺🇸Tampa, Florida, United States
Novant Health Oncology Special /ID# 139890
🇺🇸Winston-Salem, North Carolina, United States
Loyola University Medical Ctr /ID# 120455
🇺🇸Maywood, Illinois, United States
Virginia Oncology Associates /ID# 127260
🇺🇸Virginia Beach, Virginia, United States
Scottsdale Healthcare /ID# 120473
🇺🇸Scottsdale, Arizona, United States
Pacific Cancer Care /ID# 120476
🇺🇸Salinas, California, United States
Horizon Oncology Research Center /ID# 116815
🇺🇸Lafayette, Indiana, United States
Texas Oncology - Tyler /ID# 126142
🇺🇸Tyler, Texas, United States
University of Virginia /ID# 122975
🇺🇸Charlottesville, Virginia, United States
Sunnybrook Health Sciences Ctr /ID# 123312
🇨🇦Toronto, Ontario, Canada
Klinikum Bremen Mitte gGmbH /ID# 132875
🇩🇪Bremen, Germany
Onk Zentrum am Rotkreuz /ID# 133482
🇩🇪Munich, Germany
Sana Klinikum Offenbach /ID# 133455
🇩🇪Offenbach, Germany
Centre Oscar Lambret /ID# 119958
🇫🇷Lille, Hauts-de-France, France
Helios Klinikum Berlin Buch /ID# 133465
🇩🇪Berlin, Germany
Marienhospital Witten /ID# 133470
🇩🇪Witten, Germany
Uzsoki Utcai Korhaz /ID# 120825
ðŸ‡ðŸ‡ºBudapest, Hungary
Wilke/Wagner/Petzoldt, Fuerth /ID# 133481
🇩🇪Fürth, Germany
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834
ðŸ‡ðŸ‡ºBudapest, Hungary
IRCCS-I.R.S.T. srl Meldola /ID# 120255
🇮🇹Meldola, Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855
🇮🇹Bologna, Emilia-Romagna, Italy
University of Szeged /ID# 120823
ðŸ‡ðŸ‡ºSzeged, Hungary
Misericordia General Hospital /ID# 119536
🇮🇹Grosseto, Italy
National Cancer Center /ID# 119525
🇰🇷Goyang, Gyeonggido, Korea, Republic of
Samsung Medical Center /ID# 119276
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Leningrad Reg Onc Dispensery /ID# 120938
🇷🇺St. Petersburg, Russian Federation
Hospital Universitario A Coruña - CHUAC /ID# 135108
🇪🇸A Coruña, A Coruna, Spain
Hospital General Universitario Alicante /ID# 135115
🇪🇸Alicante, Spain
UF Health Cancer Center /ID# 141589
🇺🇸Orlando, Florida, United States
St. Lukes Cancer Institute /ID# 118775
🇺🇸Kansas City, Missouri, United States
Univ NC Chapel Hill /ID# 132893
🇺🇸Chapel Hill, North Carolina, United States
Univ NC Chapel Hill /ID# 147695
🇺🇸Chapel Hill, North Carolina, United States
Virginia Commonwealth Univ /ID# 141586
🇺🇸Richmond, Virginia, United States
Univ of Wisconsin Hosp/Clinics /ID# 120457
🇺🇸Madison, Wisconsin, United States
Hospital Clinico Universitario de Valencia /ID# 123076
🇪🇸Valencia, Spain
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