title: Evaluation of trastuzumab without chemotherapy as a post-operative adjuvant therapy in HER2-positive elderly breast cancer patients: randomized controlled trial [RESPECT (N-SAS BC07)].
abstract: OBJECTIVE
  This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer.
  
  
  METHODS
  Inclusion criteria are the following: histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is ≥55%. Patients are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment and cost effectiveness.
  
  
  RESULTS
  Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment period.
  
  
  CONCLUSIONS
  We hereby report the study concept.
authors.affiliation: Department of Clinical Oncology and Chemotherapy, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan. m-sawaki@med.nagoya-u.ac.jp
authors.forename: Masataka
authors.initials: M
authors.lastname: Sawaki
authors.forename: Nahomi
authors.initials: N
authors.lastname: Tokudome
authors.forename: Toshiro
authors.initials: T
authors.lastname: Mizuno
authors.forename: Takahiro
authors.initials: T
authors.lastname: Nakayama
authors.forename: Naruto
authors.initials: N
authors.lastname: Taira
authors.forename: Hiroko
authors.initials: H
authors.lastname: Bando
authors.forename: Shigeru
authors.initials: S
authors.lastname: Murakami
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Yamamoto
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kashiwaba
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Yukari
authors.initials: Y
authors.lastname: Uemura
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000191:economics / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D003362:Cost-Benefit Analysis; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006304:Health Status; D006801:Humans; D053208:Kaplan-Meier Estimate; D008727:Methotrexate / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D011788:Quality of Life; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D003520:Cyclophosphamide; D000077143:Docetaxel; D004317:Doxorubicin; D015251:Epirubicin; D005472:Fluorouracil; D008727:Methotrexate; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human