Weekly herceptin with navelbine in chemonaïve patients with HER2 positive metastatic breast cancer: A phase II multicenter trial

M. Jahanzeb, J. Mortimer, F. Yunus, D. Irwin, J. Speyer, A. Koletsky, P. Klein, T. Sabir, L. Kronish

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Herceptin (H) and Navelbine (N) are well tolerated agents with pre-clinical synergy and documented efficacy in breast cancer as recently reported by Burstein et. al. (J Clin Oncol 19: 2722-2730). Objectives: This phase II multicenter trial was initiated to evaluate the efficacy and safety of H+N as first-line treatment for HER2 overexpressing metastatic breast carcinoma patients with measurable disease. Methods: Eligible women were treated with weekly IV doses of H (4mg/kg loading dose, then 2mg/kg) and N (30mg/m2) without a break, with 4 weeks comprising a cycle. Results: As of May 10, 2001, all of the planned 40 patients have been entered. Patient characteristics are: median age 51 years (range 30-82); prior adjuvant chemo 30%; prior hormonal therapy 32%; visceral metastases 60%. Thirty two patients are evaluable for response, having received at least 2 cycles. Three CRs and 20 PRs have been observed with an overall objective response rate of 72%, while 5 patients are stable and 3 progressed. Median time to response was 8 weeks. To date, a total of 225 cycles have been administered (median 4, range 1 to 28) with dose delays in 30% of the cycles Grade 4 toxicity was limited to neutropenia experienced by 30% of patients in 10% of cycles, while 50% of patients experienced Grade 3 neutropenia in 20% of cycles. Four patients were hospitalized with fever (1 neutropenic, 1 line sepsis, 1 with tuberculosis, 1 with pneumonia), 1 patient with hematura (due to over anti-coagulation from coumadin) and 1 patient with pulmonary embolism. Non-hematologic toxicity of fatigue was observed as grade 3 in one patient and grade 4 in another patient. One patient experienced Grade 3 neurotoxicity. No severe nausea, vomiting, cardiotoxicity, or alopecia has been reported. Conclusion: These data from a multicenter trial suggest that H+N is well tolerated and very active in this patient population, and validate the previously reported single institution experience.

Original languageEnglish (US)
Number of pages1
JournalBreast cancer research and treatment
Issue number3
StatePublished - Jan 1 2001
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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