Phase II study of weekly intravenous recombinant humanized anti-p185(HER2) monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer Journal Article


Authors: Baselga, J.; Tripathy, D.; Mendelsohn, J.; Baughman, S.; Benz, C. C.; Dantis, L.; Sklarin, N. T.; Seidman, A. D.; Hudis, C. A.; Moore, J.; Rosen, P. P.; Twaddell, T.; Henderson, I. C.; Norton, L.
Article Title: Phase II study of weekly intravenous recombinant humanized anti-p185(HER2) monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer
Abstract: Purpose: Breast cancer frequently overexpresses the product of the HER2 proto-oncogene, a 185-kd growth factor receptor (p185HER2). The recombinant humanized monoclonal antibody (rhuMAb) HER2 has high affinity for p185HER2 and inhibits the growth of breast cancer cells that overexpress HER2. We evaluated the efficacy and toxicify of weekly intravenous administration of rhuMAb HER2 in patients with HER2-overexpressing metastatic breast cancer. Patients and Methods: We treated 46 patients with metastatic breast carcinomas that overexpressed HER2. Patients received a loading dose of 250 mg of intravenous rhuMAb HER2, then 10 weekly doses of 100 mg each. Patients with no disease progression at the completion of this treatment period were offered a maintenance phase of 100 mg/wk. Results: Study patients had extensive metastatic disease, and most had received extensive prior anticancer therapy. Adequate pharmacokinetic levels of rhuMAb HER2 were obtained in 90% of the patients. Toxicity was minimal and no antibodies against rhuMAb HER2 were detected in any patients. Objective responses were seen in five of 43 assessable patients, and included one complete remission and four partial remissions (overall response rate, 11.6%; 95% confidence interval, 4.36 to 25.9). Responses were observed in liver, mediastinum, lymph nodes, and chest wall lesions. Minor responses, seen in two patients, and stable disease, which occurred in 14 patients, lasted for a median of 5.1 months. Conclusion: rhuMAb HER2 is well tolerated and clinically active in patients with HER2-overexpressing metastatic breast cancers that had received extensive prior therapy. This is evidence that targeting growth factor receptors can cause regression of human cancer and justifies further evaluation of this agent. © 1996 by American Society of Clinical Oncology.
Keywords: adult; clinical article; human tissue; treatment outcome; middle aged; unclassified drug; human cell; clinical trial; diarrhea; drug efficacy; proto oncogene; metastasis; phase 2 clinical trial; breast cancer; drug administration schedule; breast neoplasms; monoclonal antibody; chill; fever; gene expression regulation; cancer inhibition; antibodies, monoclonal; neoplasm metastasis; remission; receptor, erbb-2; infusions, intravenous; intravenous drug administration; growth factor receptor; humans; human; female; priority journal; article; monoclonal antibody her2
Journal Title: Journal of Clinical Oncology
Volume: 14
Issue: 3
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1996-03-01
Start Page: 737
End Page: 744
Language: English
DOI: 10.1200/jco.1996.14.3.737
PUBMED: 8622019
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 22 November 2017 -- Source: Scopus
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MSK Authors
  1. Andrew D Seidman
    243 Seidman
  2. Clifford Hudis
    837 Hudis
  3. Larry Norton
    556 Norton
  4. Nancy T Sklarin
    46 Sklarin
  5. Paul P Rosen
    93 Rosen
  6. Jose T Baselga
    394 Baselga
  7. Lucy A Dantis
    6 Dantis