title: A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin and trastuzumab for T2 breast cancers.
abstract: OBJECTIVE
  Preclinical data indicate that the combination of docetaxel, cisplatin and trastuzumab (TCH) may have the potential for clinically significant activity against breast cancers that overexpress the her2/neu gene (HER2). An open-label phase II trial was designed to investigate the response rate and toxicity profile of TCH in breast cancer patients with a primary tumor 2-5 cm in diameter (T2) in its original size.
  
  
  METHODS
  Thirty breast cancer patients with HER2-overexpressing tumors were enrolled. Patients received 6 cycles of docetaxel at 60 mg/m(2) and cisplatin at 50 mg/m(2) given on day 1 and then every 21 days. Trastuzumab was given on day 1, cycle 1 (4 mg/kg), and then continued weekly at 2 mg/kg for 1 year or until disease progression. Tumor measurements were obtained at baseline as well as after 3 and 6 cycles of chemotherapy.
  
  
  RESULTS
  We identified 29 breast cancer patients in Taiwan, of whom 13 (44.8%) had pathological complete responses. No cardiac toxicity was observed. Hematologic grade 4 or 3 toxicities were observed in 1 of 28 patients. Non-hematologic grade 4 or 3 toxicities with a reverse pattern were observed in 6 of 29 patients.
  
  
  CONCLUSIONS
  The results of our study indicate that TCH neoadjuvant chemotherapy is feasible and active in T2 HER2-overexpressing breast cancer patients in terms of pathological complete response rate, complete response, partial response and manageable toxicities.
authors.affiliation: Comprehensive Breast Cancer Center, Changhua Christian Hospital, 135, Nanhsiao Street, Changhua 500, Taiwan, ROC.
authors.forename: Che
authors.initials: C
authors.lastname: Lin
authors.forename: Dar-Ren
authors.initials: DR
authors.lastname: Chen
authors.forename: King-Jen
authors.initials: KJ
authors.lastname: Chang
authors.forename: Tsai-Wang
authors.initials: TW
authors.lastname: Chang
authors.forename: Hwei-Chung
authors.initials: HC
authors.lastname: Wang
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D013624:Taiwan; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D002945:Cisplatin; D000077143:Docetaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab