Dose escalation and pharmacokinetic study of a humanized anti-HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer
1999

Study of a New Antibody for Breast Cancer Treatment

Sample size: 18 publication Evidence: moderate

Author Information

Author(s): Tokuda Y, Watanabe T, Omuro Y, Ando M, Katsumata N, Okumura A, Ohta M, Fujii H, Sasaki Y, Niwa T

Primary Institution: Tokai University School of Medicine

Hypothesis

Can a humanized anti-HER2 monoclonal antibody effectively treat patients with HER2/neu-overexpressing metastatic breast cancer?

Conclusion

The study found that the antibody MKC-454 is well tolerated and shows effectiveness in treating patients with refractory metastatic breast cancer.

Supporting Evidence

  • The mean trough serum concentrations increased with higher doses of MKC-454.
  • Two patients showed objective tumor responses, with one achieving a complete response.

Takeaway

Researchers tested a new medicine on 18 patients with a tough kind of breast cancer, and it worked well for some of them.

Methodology

A phase I pharmacokinetic dose escalation study was conducted with 18 patients receiving varying doses of MKC-454.

Limitations

The study had a small sample size and was limited to patients refractory to chemotherapy.

Participant Demographics

Patients with metastatic breast cancer who overexpress the HER2 proto-oncogene.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6690343

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