Phase II study of weekly gemcitabine in patients with metastatic breast cancer relapsing or failing both an anthracycline and a taxane

Breast Cancer Res Treat. 2001 Mar;66(1):83-7. doi: 10.1023/a:1010679127390.


A phase II study was performed to investigate the efficacy and tolerability of gemcitabine as third-line chemotherapy for patients with metastatic breast cancer, previously treated with both an anthracycline- and taxane-containing regimen. Twenty-three patients were treated with gemcitabine 1200 mg/m2 in a 30-min infusion on day 1, 8 and 15 of a 28 day cycle. Seventy-four percent of the patients had visceral metastases. No complete or partial responses were observed. Six patients (26%) had stable disease with a median duration of 4.0 months. The median time to progression was 1.9 months and the median survival time was 7.8 months. Neutropenia grade 3 and 4 was observed in four patients (18%). Non-hematological toxicity grade 3 included nausea and vomiting in 14%, skin toxicity in 9% and elevation of transaminases in 23% of the patients. Gemcitabine is ineffective as third-line single agent therapy in patients failing anthracycline and taxane treatment for metastatic breast cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibiotics, Antineoplastic / therapeutic use
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Bridged-Ring Compounds / therapeutic use
  • Deoxycytidine / administration & dosage*
  • Deoxycytidine / analogs & derivatives
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Humans
  • Infusions, Intravenous
  • Middle Aged
  • Neoplasm Metastasis
  • Palliative Care
  • Taxoids*
  • Treatment Failure


  • Antibiotics, Antineoplastic
  • Antimetabolites, Antineoplastic
  • Bridged-Ring Compounds
  • Taxoids
  • Deoxycytidine
  • taxane
  • gemcitabine