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Triple Negative Breast CancerPhase 3NCT02032277

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 Phase 3 study testing Cyclophosphamide, Doxorubicin and Paclitaxel in people with Triple Negative Breast Cancer, run by AbbVie at 158 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Cyclophosphamide, Doxorubicin and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
634 participants
Where
158 sitesin 15 countries
Study dates
2 Apr 2014to 12 Nov 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

158 sites in 15 countries.

158 sites in 15 countries

United States61 sites

  • Lehigh Valley Health Network /ID# 133372

    Allentown, Pennsylvania, 18103

  • Hope Womens Cancer Centers /ID# 119179

    Asheville, North Carolina, 28816

  • Univ Maryland School Medicine /ID# 119235

    Baltimore, Maryland, 21201

  • Texas Oncology - Bedford /ID# 126135

    Bedford, Texas, 76022

  • Univ NC Chapel Hill /ID# 132893

    Chapel Hill, North Carolina, 27514-4220

  • Univ NC Chapel Hill /ID# 147695

    Chapel Hill, North Carolina, 27514-4220

  • University of Virginia /ID# 122975

    Charlottesville, Virginia, 22908

  • University of Illinois - Chicago /ID# 134329

    Chicago, Illinois, 60607

  • Northwestern University Feinberg School of Medicine /ID# 133848

    Chicago, Illinois, 60611-2927

  • University of Chicago DCAM /ID# 120467

    Chicago, Illinois, 60637-1443

  • Oncology Hematology Care, Inc - Blue Ash /ID# 120478

    Cincinnati, Ohio, 45252

  • University Hospitals Case Medical Center /ID# 141691

    Cleveland, Ohio, 44106

  • Fairview Hospital /ID# 141626

    Cleveland, Ohio, 44111

  • Cleveland Clinic Main Campus /ID# 126378

    Cleveland, Ohio, 44195

  • The Ohio State University /ID# 141587

    Columbus, Ohio, 43210

  • Texas Oncology - Medical City Dallas /ID# 126140

    Dallas, Texas, 75230

  • Texas Oncology - Medical City Dallas /ID# 126141

    Dallas, Texas, 75230

  • UT Southwestern Medical Center /ID# 133849

    Dallas, Texas, 75390-7208

  • Sanford Roger Maris Cancer Cen /ID# 132394

    Fargo, North Dakota, 58102

  • Florida Cancer Specialists - Fort Myers /ID# 121835

    Fort Myers, Florida, 33916

  • Florida Cancer Specialists - Fort Myers /ID# 126379

    Fort Myers, Florida, 33916

  • The Ctr for Cancer and Blood D /ID# 120479

    Fort Worth, Texas, 76104

  • Texas Oncology - Memorial City /ID# 126139

    Houston, Texas, 77024

  • Indiana Univ School Medicine /ID# 118215

    Indianapolis, Indiana, 46202

  • Community Rgnal Cancer Care N /ID# 120456

    Indianapolis, Indiana, 46256

  • Mayo Clinic /ID# 132349

    Jacksonville, Florida, 32224

  • St. Lukes Cancer Institute /ID# 118775

    Kansas City, Missouri, 64111-5905

  • Horizon Oncology Research Center /ID# 116815

    Lafayette, Indiana, 47905

  • Comprehensive Cancer Ctrs Neva /ID# 126136

    Las Vegas, Nevada, 89169

  • Usc /Id# 123310

    Los Angeles, California, 90033

  • Univ of Wisconsin Hosp/Clinics /ID# 120457

    Madison, Wisconsin, 53792-0001

  • Solinksy Center for Cancer Care /ID# 131970

    Manchester, New Hampshire, 03103

  • Loyola University Medical Ctr /ID# 120455

    Maywood, Illinois, 60153

  • Mount Sinai Comp Cancer Ctr /ID# 133008

    Miami, Florida, 33140

  • Miami Cancer Institute - Baptist Health South Florida /ID# 126145

    Miami, Florida, 33176

  • Minnesota Oncology Hematology, PA /ID# 126144

    Minneapolis, Minnesota, 55404

  • Tennessee Oncology, PLLC /ID# 124566

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of NJ /ID# 120477

    New Brunswick, New Jersey, 08903

  • Columbia Univ Medical Center /ID# 141588

    New York, New York, 10032-3725

  • Christiana Care Health Service /ID# 137823

    Newark, Delaware, 19713

  • UF Health Cancer Center /ID# 141589

    Orlando, Florida, 32806

  • Texas Oncology - Plano East /ID# 126143

    Plano, Texas, 75075

  • Women and Infants Hospital /ID# 123476

    Providence, Rhode Island, 02905

  • Virginia Commonwealth Univ /ID# 141586

    Richmond, Virginia, 23219

  • OSF St. Anthony Medical Center /ID# 139424

    Rockford, Illinois, 61108

  • Pacific Cancer Care /ID# 120476

    Salinas, California, 93901

  • University of Utah /ID# 118677

    Salt Lake City, Utah, 84112-5500

  • Sharp Memorial Hospital /ID# 119861

    San Diego, California, 92123

  • Guthrie Medical Group, PC /ID# 124397

    Sayre, Pennsylvania, 18840

  • Scottsdale Healthcare /ID# 120473

    Scottsdale, Arizona, 85258-4566

  • Mayo Clinic - Scottsdale /ID# 139932

    Scottsdale, Arizona, 85259

  • Avera Cancer Institute /ID# 120466

    Sioux Falls, South Dakota, 57105

  • Stanford University School of Med /ID# 130316

    Stanford, California, 94305-2200

  • Moffitt Cancer Center /ID# 124063

    Tampa, Florida, 33612-9416

  • Arizona Oncology Associates, PC-HOPE /ID# 126137

    Tucson, Arizona, 85711-2701

  • Texas Oncology - Tyler /ID# 126142

    Tyler, Texas, 75702

  • Virginia Oncology Associates /ID# 127260

    Virginia Beach, Virginia, 23456

  • Cedars-Sinai Medical Center - West Hollywood /ID# 137275

    West Hollywood, California, 90048

  • Cancer Center of Kansas /ID# 134720

    Wichita, Kansas, 67214

  • Novant Health Oncology Special /ID# 139890

    Winston-Salem, North Carolina, 27103

  • St. Joseph Mercy Hospital /ID# 135875

    Ypsilanti, Michigan, 48106

Other trials in United States

Germany20 sites

  • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472

    Augsburg, 86150

  • Helios Klinikum Berlin Buch /ID# 133465

    Berlin, 13125

  • Studiengesellschaft Onk Bielef /ID# 133471

    Bielefeld, 33604

  • Klinikum Bremen Mitte gGmbH /ID# 132875

    Bremen, 28205

  • St. Johannes Hospital /ID# 133478

    Dortmund, 44137

  • Kliniken Esslingen /ID# 133475

    Esslingen am Neckar, 73730

  • Klinikum Frankfurt Hoechst /ID# 145301

    Frankfurt, 65929

  • Wilke/Wagner/Petzoldt, Fuerth /ID# 133481

    Fürth, 90766

  • Evangelisches Krankenhaus /ID# 133457

    Gelsenkirchen, 45879

  • Elisabeth Krankenhaus /ID# 133461

    Kassel, 34117

  • Universitaetsklinikum Schleswig-Holstein /ID# 133454

    Kiel, Schleswig-Holstein, 24105

  • St. Vincenz Krankenhaus /ID# 133466

    Limburg, 65549

  • Onk Zentrum am Rotkreuz /ID# 133482

    Munich, 80634

  • Klinikum recht der Isar der TU /ID# 133449

    Munich, 80802

  • Sana Klinikum Offenbach /ID# 133455

    Offenbach, 63069

  • Leopoldina-Krankenhaus /ID# 133484

    Schweinfurt, 97422

  • Johanniter-Krankenhaus Genthin /ID# 133463

    Stendal, 39576

  • Universitaetsklinikum Ulm /ID# 133453

    Ulm, Thuringia, 89081

  • St. Josefs-Hospital /ID# 133464

    Wiesbaden, 65189

  • Marienhospital Witten /ID# 133470

    Witten, 58452

Other trials in Germany

Spain13 sites

  • Hospital Universitario A Coruña - CHUAC /ID# 135108

    A Coruña, A Coruna, 15006

  • Hospital General Universitario Alicante /ID# 135115

    Alicante, 03010

  • Hospital Universitario Germans Trias i Pujol /ID# 135112

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 135110

    Barcelona, 08003

  • Hospital Santa Creu i Sant Pau /ID# 145400

    Barcelona, 08041

  • Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979

    Lleida, 25198

  • Hospital Universitario Ramon y Cajal /ID# 135113

    Madrid, 28034

  • Hospital Clinico Universitario San Carlos /ID# 119959

    Madrid, 28040

  • Hospital Universitario Virgen del Rocio /ID# 135114

    Seville, 41013

  • Fundacion Instituto Valenciano Oncologia IVO /ID# 135116

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia /ID# 123076

    Valencia, 46010

  • Hospital General Universitario de Valencia /ID# 135111

    Valencia, 46014

  • Hospital Universitario Miguel Servet /ID# 119195

    Zaragoza, 50009

Other trials in Spain

Hungary9 sites

  • National Institute of Oncology /ID# 120828

    Budapest, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834

    Budapest, 1134

  • Uzsoki Utcai Korhaz /ID# 120825

    Budapest, 1145

  • Debreceni Egyetem Klinikai Kozpont /ID# 116681

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korh /ID# 120835

    Győr, 9023

  • Bacs-Kiskun Megyei Korhaz /ID# 120833

    Kecskemét, 6000

  • BAZ Megyei E.O. Korhaz /ID# 122215

    Miskolc, 3526

  • University of Szeged /ID# 120823

    Szeged, 6720

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818

    Szolnok, 5004

Other trials in Hungary

South Korea8 sites

  • Kyungpook National University Chilgok Hospital /ID# 118855

    Daegu, Seoul Teugbyeolsi, 41404

  • National Cancer Center /ID# 119525

    Goyang, Gyeonggido, 10408

  • Severance Hospital /ID# 116699

    Seoul, Seoul Teugbyeolsi, 03722

  • Samsung Medical Center /ID# 119276

    Seoul, Seoul Teugbyeolsi, 06351

  • Korea University Anam Hospital /ID# 118857

    Seoul, 02841

  • Seoul National University Hospital /ID# 116698

    Seoul, 03080

  • Asan Medical Center /ID# 116696

    Seoul, 05505

  • Ajou University Hospital /ID# 118856

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Australia7 sites

  • Cabrini Health /ID# 120236

    Malvern, Victoria, 3144

  • Fiona Stanley Hospital /ID# 120716

    Murdoch, Western Australia, 6150

  • St. John of God Hosp - Murdoch /ID# 131788

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital /ID# 127717

    Parkville, Victoria, 3050

  • Western Health Sunshine Hosp. /ID# 120715

    St Albans, Victoria, 3021

  • St. John of God Subiaco Hosp /ID# 120717

    Subiaco, Western Australia, 6008

  • The Tweed Hospital /ID# 120235

    Tweed Heads, New South Wales, 2485

Other trials in Australia

France7 sites

  • Jean Perrin Centre /ID# 125277

    Clermont-Ferrand, 63011

  • Centre Oscar Lambret /ID# 119958

    Lille, Hauts-de-France, 59020

  • Centre Leon Berard /ID# 120740

    Lyon, Rhone, 69373

  • Hosp European, Georges Pompid /ID# 120736

    Paris, 75015

  • Institut Curie /ID# 116679

    Paris, Île-de-France Region, 75248

  • Hopital Rene Huguenin /ID# 120729

    Saint-Cloud, 92210

  • Hopital Universitaire Purpan /ID# 120731

    Toulouse, Haute-Garonne, 31059

Other trials in France

Russia7 sites

  • archangel Clinical Oncology /ID# 120935

    Arkhangelsk, 163045

  • Kursk Regional Oncology Dispen /ID# 116688

    Kursk, Tatarstan, Respublika, 305035

  • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944

    Moscow, Moscow, 115478

  • Medical Radiological Res Ctr /ID# 124017

    Obninsk, 249036

  • Pyatigorsk Oncology Dispensary /ID# 120945

    Pyatigorsk, 357502

  • Leningrad Reg Onc Dispensery /ID# 120938

    Saint Petersburg, 188663

  • Birch A Healthcare /ID# 116695

    Saint Petersburg, 197183

Other trials in Russia

Belgium6 sites

  • CHU Brugmann /ID# 120376

    Brussels, 1020

  • Grand Hôpital de Charleroi /ID# 116678

    Charleroi, Hainaut, 6000

  • UZ Antwerp /ID# 120720

    Edegem, 2650

  • AZ Groeninge /ID# 120718

    Kortrijk, 8500

  • CHU UCL Namur /ID# 116677

    Namur, 5000

  • Cliniques Universitaires Saint Luc /ID# 120719

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Italy5 sites

  • A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855

    Bologna, Emilia-Romagna, 40138

  • Misericordia General Hospital /ID# 119536

    Grosseto, 58100

  • IRCCS-I.R.S.T. srl Meldola /ID# 120255

    Meldola, 47014

  • Istituto Europeo di Oncologia /ID# 120845

    Milan, 20141

  • IRCCS Fondazione Salva Maugeri /ID# 120848

    Pavia, 27100

Other trials in Italy

Canada4 sites

  • CHUM - Notre-Dame Hospital /ID# 141694

    Montreal, Quebec, H2X 0A9

  • Jewish General Hospital /ID# 141629

    Montreal, Quebec, H3T 1E2

  • CHUQ-Hospital St. Sacrement /ID# 141619

    Québec, Quebec, G1S 4L8

  • Sunnybrook Health Sciences Ctr /ID# 123312

    Toronto, Ontario, M4N 3M5

Other trials in Canada

United Kingdom4 sites

  • Univ Hosp Bristol NHS Foundati /ID# 120989

    Bristol, BS2 8EG

  • Charing Cross Hospital /ID# 120990

    London, W6 8RF

  • Nottingham Univ Hospitals NHS /ID# 122218

    Nottingham, NG5 1PB

  • Royal Stoke Univ Hospital /ID# 120984

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Czechia3 sites

  • Masarykuv onkologikcy ustav /ID# 120726

    Brno, 656 53

  • FN Hradec Kralove /ID# 120596

    Hradec Králové, 500 05

  • Fakultni Nemocnice Olomouc /ID# 120725

    Olomouc, Olomouc Region, 779 00

Other trials in Czechia

Taiwan3 sites

  • Changhua Christian Hospital /ID# 119085

    Changhua County, 50006

  • Chi Mei Hospital - Liouying /ID# 120982

    Tainan, 73657

  • National Taiwan Univ Hosp /ID# 122895

    Taipei City, Taipei, 10002

Other trials in Taiwan

Netherlands1 site

  • Vrije Universiteit Medisch Centrum /ID# 126302

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

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)

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.

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
Medical subject headings
Triple Negative Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02032277
Study groupRoleWhat they receive
Arm AActive comparatorVeliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Paclitaxel; Drug: Carboplatin; Drug: Veliparib
Arm CPlacebo comparatorPlacebo + placebo + paclitaxel followed by AC.
Receives: Drug: Cyclophosphamide; Drug: Placebo; Drug: Doxorubicin; Drug: Paclitaxel
Arm BPlacebo comparatorPlacebo + carboplatin + paclitaxel followed by AC
Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).

Secondary outcomes (3)

  1. 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.

    Measured: Up to 4 years from the date of definitive surgery.

  2. 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.

    Measured: Up to 4 years from the date of definitive surgery.

  3. 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.

    Measured: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2014 (estimated)
  2. Study start2 Apr 2014
  3. Primary completion18 Mar 2016
  4. Study completion12 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
634 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032277
Sponsor's protocol ID
M14-011
Other IDs
2013-002377-21
Status last verified
Jan 2021
First submitted
13 Dec 2013
Last updated
20 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

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.

    PubMed 33599688

  • 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.

    PubMed 31913413

  • 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.

    PubMed 31606288

  • 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.

    PubMed 29501363

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, Doxorubicin and Paclitaxel in people with Triple Negative Breast Cancer, run by AbbVie at 158 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Germany, Spain, Hungary, South Korea and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR). (time frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02032277, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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