Phase II trial with oral idarubicin in advanced breast cancer

Massimo Lopez, Luigi Di Lauro, Paola Papaldo, Bonaventura Lazzaro, Fabrizio Ganzina, Nicola Di Pietro

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Idarubicin, a new analogue of daunorubicin, was administered to 27 patients with advanced breast cancer in a phase II trial. The drug was given orally at a dose of 30-35 mg/m2 every 3 weeks. Twenty-two patients were evaluable for response. All evaluable patients were previously treated with one or more chemotherapeutic regimens, including an anthracycline in more than 50% of the cases. Partial remissions were obtained in 5 patients, for a response rate of 23%. The median duration of response was 191 days. Mild nausea and vomiting were common. Diarrhea, which occurred in less than 50% of the patients, was usually short-lived. Alopecia was generally minimal. Myelosuppression was the dose-limiting toxic effect. Leukopenia was frequently seen, with full recovery by day 28 in 81 % of the courses. Thrombocytopenia was less common than leukopenia. Four cases of grade 1 acute cardiac toxicity were recorded. This study suggests that idarubicin can induce regressions in advanced carcinoma of the breast, and justifies further studies in combination with other agents.

Original languageEnglish
Pages (from-to)39-42
Number of pages4
JournalInvestigational New Drugs
Issue number1
Publication statusPublished - Mar 1986


  • breast cancer
  • chemotherapy
  • idarubicin

ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine


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