title: A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial.
abstract: OBJECTIVE
  To determine the response rate and toxicity profile of trastuzumab and capecitabine in women with HER2-overexpressing advanced breast cancer.
  
  
  METHODS
  A total of 59 patients from 6 participating centers in Japan entered onto the study of trastuzumab and capecitabine. Eighty six percent of women had received prior chemotherapy as part of adjuvant (21.4%) or metastatic treatment (48.2%), or both (16.1%), including substantial portions of patients who had previously received either CMF (7.1%), anthracyclines (28.6%), taxanes (25.0%), or both types (25.0%) of chemotherapy.
  
  
  RESULTS
  Responses were observed in 28 of 56 patients (overall response rate, 50%). The response rate was 65.0% in patients treated with trastuzumab and capecitabine as first-line therapy for metastatic disease, and 62.5% among HER2 +3 positive patients, while high response rates were also seen in women treated with second- or third-line therapy. Patients receiving trastuzumab and capecitabine as first-line therapy had a longer TTP than did patients receiving this treatment as second- or third-line therapy (median TTP, 280 vs. 130 days, P < 0.05). Further, patients receiving trastuzumab and capecitabine as first-line therapy had longer OS than did patients receiving this treatment as second- or third-line therapy (median OS, 780 days vs. 480 weeks, P < 0.05). The treatment-related adverse events were hand-foot syndrome (30.4%), nausea (25%), diarrhea (10.7%), stomatitis (10.7%), fatigue (7.1%), and vomiting (5.4%). However, the majority were Grade 1-2 adverse events and only six patients experienced Grade 3 adverse events. Further Grade 1 cardiac toxicity was observed in one patient, while there were no cases of alopecia and treatment-related death.
  
  
  CONCLUSIONS
  Trastuzumab in combination with capecitabine is highly active in women with HER2-overexpressing metastatic breast cancer and is well tolerated.
authors.affiliation: Department of Surgery, Kansai Medical University Hirakata Hospital, Hirakata, Osaka 573-1191, Japan. yamamotd@hirakata.kmu.ac.jp
authors.forename: Daigo
authors.initials: D
authors.lastname: Yamamoto
authors.forename: Satoru
authors.initials: S
authors.lastname: Iwase
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kitamura
authors.forename: Hiroki
authors.initials: H
authors.lastname: Odagiri
authors.forename: Chizuko
authors.initials: C
authors.lastname: Yamamoto
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Nagumo
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D018734:Genes, erbB-2 / Q000235:genetics*; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D008875:Middle Aged; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000069287:Capecitabine; D000068878:Trastuzumab; D005472:Fluorouracil