Journal ArticleDOI
Randomized Phase II Trial of the Efficacy and Safety of Trastuzumab Combined With Docetaxel in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Administered As First-Line Treatment: The M77001 Study Group
M Marty,Francesco Cognetti,Dominique Maraninchi,Raymond Snyder,Louis Mauriac,Michèle Tubiana-Hulin,Stephen Chan,David Grimes,Antonio Antón,Anna Lluch,John Kennedy,Kenneth J. O'Byrne,Pierfranco Conte,Michael D. Green,Carol Ward,Karen Mayne,Jean-Marc Extra +16 more
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TLDR
Tastuzumab combined with docetaxel is superior to docetAXel alone as first-line treatment of patients with HER2-positive MBC in terms of overall survival, response rate, response duration, time to progression, and time to treatment failure, with little additional toxicity.Abstract:
Purpose This randomized, multicenter trial compared first-line trastuzumab plus docetaxel versus docetaxel alone in patients with human epidermal growth factor receptor 2 (HER2) –positive metastatic breast cancer (MBC). Patients and Methods Patients were randomly assigned to six cycles of docetaxel 100 mg/m2 every 3 weeks, with or without trastuzumab 4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression. Results A total of 186 patients received at least one dose of the study drug. Trastuzumab plus docetaxel was significantly superior to docetaxel alone in terms of overall response rate (61% v 34%; P = .0002), overall survival (median, 31.2 v 22.7 months; P = .0325), time to disease progression (median, 11.7 v 6.1 months; P = .0001), time to treatment failure (median, 9.8 v 5.3 months; P = .0001), and duration of response (median, 11.7 v 5.7 months; P = .009). There was little difference in the number and severity of adverse events between the arms. Grade 3 to 4 neutropenia was seen mor...read more
Citations
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Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer
Martine Piccart-Gebhart,Marion Procter,Brian Leyland-Jones,Aron Goldhirsch,Michael Untch,Ian E. Smith,Luca Gianni,José Baselga,Richard Bell,Christian Jackisch,David Cameron,Mitch Dowsett,Carlos H. Barrios,Günther G. Steger,Chiun-Shen Huang,Martin Andersson,Moshe Inbar,Mikhail Lichinitser,István Láng,U. Nitz,Hiroji Iwata,C Thomssen,Caroline Lohrisch,Thomas M. Suter,Josef Rüschoff,Tamás Süto ý,Victoria Greatorex,Carol Ward,Eleanor McFadden,M. Stella Dolci,Richard D. Gelber +30 more
TL;DR: One year of treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer.
Journal ArticleDOI
Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer
Sunil Verma,David Miles,Luca Gianni,Ian E. Krop,Manfred Welslau,José Baselga,Mark D. Pegram,Do Youn Oh,Véronique Diéras,Ellie Guardino,Liang Fang,M. Lu,Steven R. Olsen,K. L. Blackwell +13 more
TL;DR: T-DM1 significantly prolonged progression-free and overall survival with less toxicity than lapatinib plus capecitabine in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane.
Journal ArticleDOI
Trastuzumab — Mechanism of Action and Use in Clinical Practice
TL;DR: Trastuzumab, a humanized monoclonal antibody that targets HER2, is approved by the Food and Drug Administration for patients with invasive breast cancers that overexpress HER2.
Journal ArticleDOI
Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer
José Baselga,Javier Cortes,Sung-Bae Kim,Seock-Ah Im,Roberto Hegg,Young-Hyuck Im,L Roman,Jose Luiz Pedrini,Tadeusz Pienkowski,Adam Knott,Emma Clark,Mark C. Benyunes,Graham Ross,Sandra M. Swain +13 more
TL;DR: The combination of pertuzumab plus trastuzumAB plus docetaxel, when used as first-line treatment for HER2-positive metastatic breast cancer, significantly prolonged progression-free survival, with no increase in cardiac toxic effects.
Journal ArticleDOI
Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial
Luca Gianni,Tadeusz Pienkowski,Young Hyuck Im,L Roman,Ling Ming Tseng,Mei Ching Liu,Ana Lluch,Elżbieta Starosławska,Juan de la Haba-Rodriguez,Seock-Ah Im,Jose Luiz Pedrini,Brigitte Poirier,Paolo Morandi,Vladimir Semiglazov,Vichien Srimuninnimit,Giulia Bianchi,Tania Szado,Jayantha Ratnayake,Graham Ross,Pinuccia Valagussa +19 more
TL;DR: Pertuzumab and trastuzumAB without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile, which justifies further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer.
References
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Journal ArticleDOI
Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene
Dennis J. Slamon,Gary M. Clark,Steven G. Wong,Wendy J. Levin,Axel Ullrich,William L. McGuire +5 more
TL;DR: Amplification of the HER-2/neu gene was a significant predictor of both overall survival and time to relapse in patients with breast cancer, and had greater prognostic value than most currently used prognostic factors in lymph node-positive disease.
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Use of Chemotherapy plus a Monoclonal Antibody against HER2 for Metastatic Breast Cancer That Overexpresses HER2
Dennis J. Slamon,Brian Leyland-Jones,Steven Shak,Hank Fuchs,Virginia E. Paton,Alex Bajamonde,Thomas Fleming,Wolfgang Eiermann,Janet M. Wolter,Mark D. Pegram,José Baselga,Larry Norton +11 more
TL;DR: The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression, a higher rate of objective response, a longer duration of response, and a lower rate of death at 1 year.
Journal ArticleDOI
Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer.
Dennis J. Slamon,William Godolphin,Lovell A. Jones,John A. Holt,Steven G. Wong,Duane E. Keith,Wendy J. Levin,Susan G. Stuart,Judy Udove,Axel Ullrich,Michael F. Press +10 more
TL;DR: The concept that the HER-2/neu gene may be involved in the pathogenesis of some human cancers, including breast and ovarian cancer, is supported.
Journal ArticleDOI
Efficacy and Safety of Trastuzumab as a Single Agent in First-Line Treatment of HER2-Overexpressing Metastatic Breast Cancer
Charles L. Vogel,Melody A. Cobleigh,Debu Tripathy,John Gutheil,Lyndsay Harris,Louis Fehrenbacher,Dennis J. Slamon,Maureen E. Murphy,William Novotny,Michael Burchmore,Steven Shak,Stanford J. Stewart,Michael F. Press +12 more
TL;DR: Single-agent trastuzumab is active and well tolerated as first-line treatment of women with metastatic breast cancer with HER2 3+ overexpression by IHC or gene amplification by FISH.
Journal ArticleDOI
Multinational Study of the Efficacy and Safety of Humanized Anti-HER2 Monoclonal Antibody in Women Who Have HER2-Overexpressing Metastatic Breast Cancer That Has Progressed After Chemotherapy for Metastatic Disease
Melody A. Cobleigh,Charles L. Vogel,Debasish Tripathy,Nicholas J. Robert,Susy Scholl,Louis Fehrenbacher,Janet M. Wolter,Virginia Paton,Steven Shak,Gracie Lieberman,Dennis J. Slamon +10 more
TL;DR: Recombinant humanized anti-HER2 monoclonal antibody, administered as a single agent, produces durable objective responses and is well tolerated by women with HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease.
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