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Journal of Clinical Oncology, Vol 17, Issue 9 (September), 1999: 2639
© 1999 American Society for Clinical Oncology

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, Debu Tripathy, Nicholas J. Robert, Susy Scholl, Louis Fehrenbacher, Janet M. Wolter, Virginia Paton, Steven Shak, Gracie Lieberman, Dennis J. Slamon

From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France.

Address reprint requests to Melody A. Cobleigh, MD, Rush-Presbyterian-St Luke's Medical Center, Professional Building, 1725 West Harrison, Suite 821, Chicago, IL 60612

PURPOSE: Overexpression of the HER2 protein occurs in 25% to 30% of human breast cancers and leads to a particularly aggressive form of the disease. Efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody as a single agent was evaluated in women with HER2-overexpressing metastatic breast cancer that had progressed after chemotherapy for metastatic disease.

PATIENTS AND METHODS: Two hundred twenty-two women, with HER2-overexpressing metastatic breast cancer that had progressed after one or two chemotherapy regimens, were enrolled. Patients received a loading dose of 4 mg/kg intravenously, followed by a 2-mg/kg maintenance dose at weekly intervals.

RESULTS: Study patients had advanced metastatic disease and had received extensive prior therapy. A blinded, independent response evaluation committee identified eight complete and 26 partial responses, for an objective response rate of 15% in the intent-to-treat population (95% confidence interval, 11% to 21%). The median duration of response was 9.1 months; the median duration of survival was 13 months. The most common adverse events, which occurred in approximately 40% of patients, were infusion-associated fever and/or chills that usually occurred only during the first infusion, and were of mild to moderate severity. These symptoms were treated successfully with acetaminophen and/or diphenhydramine. The most clinically significant adverse event was cardiac dysfunction, which occurred in 4.7% of patients. Only 1% of patients discontinued the study because of treatment-related adverse events.

CONCLUSION: 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. Side effects that are commonly observed with chemotherapy, such as alopecia, mucositis, and neutropenia, are rarely seen.


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C. Catania, M. Medici, E. Magni, E. Munzone, D. Cardinale, L. Adamoli, G. Sanna, I. Minchella, D. Radice, A. Goldhirsch, et al.
Optimizing clinical care of patients with metastatic breast cancer: a new oral vinorelbine plus trastuzumab combination
Ann. Onc., December 1, 2007; 18(12): 1969 - 1975.
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L. Harris, H. Fritsche, R. Mennel, L. Norton, P. Ravdin, S. Taube, M. R. Somerfield, D. F. Hayes, and R. C. Bast Jr
American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer
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K. S. Garman, J. R. Nevins, and A. Potti
Genomic strategies for personalized cancer therapy
Hum. Mol. Genet., October 15, 2007; 16(R2): R226 - R232.
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S. R. Kumar, T. P. Quinn, and S. L. Deutscher
Evaluation of an 111In-Radiolabeled Peptide as a Targeting and Imaging Agent for ErbB-2 Receptor Expressing Breast Carcinomas
Clin. Cancer Res., October 15, 2007; 13(20): 6070 - 6079.
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L. Pusztai, K. Anderson, and K. R. Hess
Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer
Clin. Cancer Res., October 15, 2007; 13(20): 6080 - 6086.
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R. S. Herbst, A. M. Davies, R. B. Natale, T. P. Dang, J. H. Schiller, L. L. Garland, V. A. Miller, D. Mendelson, A. D. Van den Abbeele, Y. Melenevsky, et al.
Efficacy and Safety of Single-Agent Pertuzumab, a Human Epidermal Receptor Dimerization Inhibitor, in Patients with Non Small Cell Lung Cancer
Clin. Cancer Res., October 15, 2007; 13(20): 6175 - 6181.
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C.-H. Lu, S. L. Wyszomierski, L.-M. Tseng, M.-H. Sun, K.-H. Lan, C. L. Neal, G. B. Mills, G. N. Hortobagyi, F. J. Esteva, and D. Yu
Preclinical Testing of Clinically Applicable Strategies for Overcoming Trastuzumab Resistance Caused by PTEN Deficiency
Clin. Cancer Res., October 1, 2007; 13(19): 5883 - 5888.
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C. Taylor, D. Hershman, N. Shah, N. Suciu-Foca, D. P. Petrylak, R. Taub, L. Vahdat, B. Cheng, M. Pegram, K. L. Knutson, et al.
Augmented HER-2 Specific Immunity during Treatment with Trastuzumab and Chemotherapy
Clin. Cancer Res., September 1, 2007; 13(17): 5133 - 5143.
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S.-A. Pearson, C. L. Ringland, and R. L. Ward
Trastuzumab and Metastatic Breast Cancer: Trastuzumab Use in Australia Monitoring the Effect of an Expensive Medicine Access Program
J. Clin. Oncol., August 20, 2007; 25(24): 3688 - 3693.
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D. L. Costantini, C. Chan, Z. Cai, K. A. Vallis, and R. M. Reilly
111In-Labeled Trastuzumab (Herceptin) Modified with Nuclear Localization Sequences (NLS): An Auger Electron-Emitting Radiotherapeutic Agent for HER2/neu-Amplified Breast Cancer
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C. A. Hudis
Trastuzumab -- Mechanism of Action and Use in Clinical Practice
N. Engl. J. Med., July 5, 2007; 357(1): 39 - 51.
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S. D. Allen, J. T. Garrett, S. V. Rawale, A. L. Jones, G. Phillips, G. Forni, J. C. Morris, R. G. Oshima, and P. T. P. Kaumaya
Peptide Vaccines of the HER-2/neu Dimerization Loop Are Effective in Inhibiting Mammary Tumor Growth In Vivo
J. Immunol., July 1, 2007; 179(1): 472 - 482.
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 The OncologistHome page
S. Gori, S. Rimondini, V. De Angelis, M. Colozza, G. Bisagni, G. Moretti, A. Sidoni, C. Basurto, C. Aristei, P. Anastasi, et al.
Central Nervous System Metastases in HER-2 Positive Metastatic Breast Cancer Patients Treated with Trastuzumab: Incidence, Survival, and Risk Factors
Oncologist, July 1, 2007; 12(7): 766 - 773.
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N. L. Spector, Y. Yarden, B. Smith, L. Lyass, P. Trusk, K. Pry, J. E. Hill, W. Xia, R. Seger, and S. S. Bacus
Activation of AMP-activated protein kinase by human EGF receptor 2/EGF receptor tyrosine kinase inhibitor protects cardiac cells
PNAS, June 19, 2007; 104(25): 10607 - 10612.
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M. H.A. Hussain, G. R. MacVicar, D. P. Petrylak, R. L. Dunn, U. Vaishampayan, P. N. Lara Jr, G. S. Chatta, D. M. Nanus, L. M. Glode, D. L. Trump, et al.
Trastuzumab, Paclitaxel, Carboplatin, and Gemcitabine in Advanced Human Epidermal Growth Factor Receptor-2/neu-Positive Urothelial Carcinoma: Results of a Multicenter Phase II National Cancer Institute Trial
J. Clin. Oncol., June 1, 2007; 25(16): 2218 - 2224.
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B. J. Stish, H. Chen, Y. Shu, A. Panoskaltsis-Mortari, and D. A. Vallera
Increasing Anticarcinoma Activity of an Anti-erbB2 Recombinant Immunotoxin by the Addition of an Anti-EpCAM sFv
Clin. Cancer Res., May 15, 2007; 13(10): 3058 - 3067.
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N. Dendukuri, K. Khetani, M. McIsaac, and J. Brophy
Testing for HER2-positive breast cancer: a systematic review and cost-effectiveness analysis
Can. Med. Assoc. J., May 8, 2007; 176(10): 1429 - 1434.
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M. C. Abba, V. T. Fabris, Y. Hu, F. S. Kittrell, W.-W. Cai, L. A. Donehower, A. Sahin, D. Medina, and C. M. Aldaz
Identification of Novel Amplification Gene Targets in Mouse and Human Breast Cancer at a Syntenic Cluster Mapping to Mouse ch8A1 and Human ch13q34
Cancer Res., May 1, 2007; 67(9): 4104 - 4112.
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M. Scaltriti, F. Rojo, A. Ocana, J. Anido, M. Guzman, J. Cortes, S. Di Cosimo, X. Matias-Guiu, S. Ramon y Cajal, J. Arribas, et al.
Expression of p95HER2, a Truncated Form of the HER2 Receptor, and Response to Anti-HER2 Therapies in Breast Cancer
J Natl Cancer Inst, April 18, 2007; 99(8): 628 - 638.
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B. Chabner
Phase II Cancer Trials: Out of Control?
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E. T. Olejniczak, C. Van Sant, M. G. Anderson, G. Wang, S. K. Tahir, G. Sauter, R. Lesniewski, and D. Semizarov
Integrative Genomic Analysis of Small-Cell Lung Carcinoma Reveals Correlates of Sensitivity to Bcl-2 Antagonists and Uncovers Novel Chromosomal Gains
Mol. Cancer Res., April 1, 2007; 5(4): 331 - 339.
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S. A. Limentani, A. M. Brufsky, J. K. Erban, M. Jahanzeb, and D. Lewis
Phase II Study of Neoadjuvant Docetaxel, Vinorelbine, and Trastuzumab Followed by Surgery and Adjuvant Doxorubicin Plus Cyclophosphamide in Women With Human Epidermal Growth Factor Receptor 2-Overexpressing Locally Advanced Breast Cancer
J. Clin. Oncol., April 1, 2007; 25(10): 1232 - 1238.
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A. J. Murphy, C. A. Hughes, C. Barrett, H. Magee, B. Loftus, J. J. O'Leary, and O. Sheils
Low-Level TOP2A Amplification in Prostate Cancer Is Associated with HER2 Duplication, Androgen Resistance, and Decreased Survival
Cancer Res., March 15, 2007; 67(6): 2893 - 2898.
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M. Colozza, E. de Azambuja, N. Personeni, F. Lebrun, M. J. Piccart, and F. Cardoso
Achievements in Systemic Therapies in the Pregenomic Era in Metastatic Breast Cancer
Oncologist, March 1, 2007; 12(3): 253 - 270.
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B. J. Czerniecki, G. K. Koski, U. Koldovsky, S. Xu, P. A. Cohen, R. Mick, H. Nisenbaum, T. Pasha, M. Xu, K. R. Fox, et al.
Targeting HER-2/neu in Early Breast Cancer Development Using Dendritic Cells with Staged Interleukin-12 Burst Secretion
Cancer Res., February 15, 2007; 67(4): 1842 - 1852.
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L. N. Harris, F. You, S. J. Schnitt, A. Witkiewicz, X. Lu, D. Sgroi, P. D. Ryan, S. E. Come, H. J. Burstein, B.-A. Lesnikoski, et al.
Predictors of Resistance to Preoperative Trastuzumab and Vinorelbine for HER2-Positive Early Breast Cancer
Clin. Cancer Res., February 15, 2007; 13(4): 1198 - 1207.
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W. Xia, I. Husain, L. Liu, S. Bacus, S. Saini, J. Spohn, K. Pry, R. Westlund, S. H. Stein, and N. L. Spector
Lapatinib Antitumor Activity Is Not Dependent upon Phosphatase and Tensin Homologue Deleted on Chromosome 10 in ErbB2-Overexpressing Breast Cancers
Cancer Res., February 1, 2007; 67(3): 1170 - 1175.
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R. Nahta, L. X.H. Yuan, Y. Du, and F. J. Esteva
Lapatinib induces apoptosis in trastuzumab-resistant breast cancer cells: effects on insulin-like growth factor I signaling
Mol. Cancer Ther., February 1, 2007; 6(2): 667 - 674.
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S Beslija, J Bonneterre, H Burstein, V Cocquyt, M Gnant, P Goodwin, V Heinemann, J Jassem, W. Kostler, M Krainer, et al.
Second consensus on medical treatment of metastatic breast cancer
Ann. Onc., February 1, 2007; 18(2): 215 - 225.
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C. R. James, J. E. Quinn, P. B. Mullan, P. G. Johnston, and D. P. Harkin
BRCA1, a Potential Predictive Biomarker in the Treatment of Breast Cancer
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