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)]

Masataka Sawaki, Nahomi Tokudome, Toshiro Mizuno, Takahiro Nakayama, Naruto Taira, Hiroko Bando, Shigeru Murakami, Yutaka Yamamoto, Masahiro Kashiwaba, Hiroji Iwata, Yukari Uemura, Yasuo Ohashi

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28 Citations (Scopus)

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, relapsefree 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.

Original languageEnglish
Article numberhyr011
Pages (from-to)709-712
Number of pages4
JournalJapanese journal of clinical oncology
Volume41
Issue number5
DOIs
Publication statusPublished - May 2011

Keywords

  • Breast cancer
  • Elderly
  • HER2/neu
  • Monotherapy
  • Phase III
  • Trastuzumab

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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    Sawaki, M., Tokudome, N., Mizuno, T., Nakayama, T., Taira, N., Bando, H., Murakami, S., Yamamoto, Y., Kashiwaba, M., Iwata, H., Uemura, Y., & Ohashi, Y. (2011). 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)]. Japanese journal of clinical oncology, 41(5), 709-712. [hyr011]. https://doi.org/10.1093/jjco/hyr011