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)

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.

Study Overview

• Status: Completed
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Carboplatin; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Veliparib; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 634
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm A; Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)	Drug: Cyclophosphamide; Cyclophosphamide; Drug: Carboplatin; Carboplatin; Drug: Paclitaxel; Paclitaxel; Drug: Doxorubicin; Doxorubicin; Drug: Veliparib; Veliparib; Other Names: ABT-888
PLACEBO_COMPARATOR: Arm C; Placebo + placebo + paclitaxel followed by AC.	Drug: Cyclophosphamide; Cyclophosphamide; Drug: Paclitaxel; Paclitaxel; Drug: Doxorubicin; Doxorubicin; Drug: Placebo; Placebo for Carboplatin; Drug: Placebo; Placebo for Veliparib
PLACEBO_COMPARATOR: Arm B; Placebo + carboplatin + paclitaxel followed by AC	Drug: Cyclophosphamide; Cyclophosphamide; Drug: Carboplatin; Carboplatin; Drug: Paclitaxel; Paclitaxel; Drug: Doxorubicin; Doxorubicin; Drug: Placebo; Placebo for Carboplatin; Drug: Placebo; Placebo for Veliparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Free Survival (EFS)	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.	Up to 4 years from the date of definitive surgery.
Overall Survival (OS)	OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.	Up to 4 years from the date of definitive surgery.
Rate of eligibility for breast conservation after therapy (BCR).	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.	At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: NSABP Foundation Inc; German Breast Group; US Oncology Research; Grupo Espanol de Investigacion del Cancer de Mama

Publications and helpful links

General Publications

• 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.
• Golshan 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. Erratum In: JAMA Surg. 2021 May 1;156(5):503.
• Golshan 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.
• Loibl 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2014
• Primary Completion (ACTUAL): March 18, 2016
• Study Completion (ACTUAL): November 12, 2020

Study Registration Dates

• First Submitted: December 13, 2013
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (ESTIMATE): January 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: 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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Carboplatin; Paclitaxel; Doxorubicin; Veliparib
• Other Study ID Numbers: M14-011; 2013-002377-21 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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