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

Research output: Contribution to journalArticle

27 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

Fingerprint

Randomized Controlled Trials
Breast Neoplasms
Drug Therapy
Geriatric Assessment
Survival
Therapeutics
Stroke Volume
Patient Selection
Disease-Free Survival
Cost-Benefit Analysis
Quality of Life
Safety
Trastuzumab

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging

Cite this

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

In: Japanese Journal of Clinical Oncology, Vol. 41, No. 5, hyr011, 05.2011, p. 709-712.

Research output: Contribution to journalArticle

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, vol. 41, no. 5, hyr011, pp. 709-712. https://doi.org/10.1093/jjco/hyr011
Sawaki, Masataka ; Tokudome, Nahomi ; Mizuno, Toshiro ; Nakayama, Takahiro ; Taira, Naruto ; Bando, Hiroko ; Murakami, Shigeru ; Yamamoto, Yutaka ; Kashiwaba, Masahiro ; Iwata, Hiroji ; Uemura, Yukari ; Ohashi, Yasuo. / 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)]. In: Japanese Journal of Clinical Oncology. 2011 ; Vol. 41, No. 5. pp. 709-712.
@article{62d1763389f84b30942690309463b296,
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, 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.",
keywords = "Breast cancer, Elderly, HER2/neu, Monotherapy, Phase III, Trastuzumab",
author = "Masataka Sawaki and Nahomi Tokudome and Toshiro Mizuno and Takahiro Nakayama and Naruto Taira and Hiroko Bando and Shigeru Murakami and Yutaka Yamamoto and Masahiro Kashiwaba and Hiroji Iwata and Yukari Uemura and Yasuo Ohashi",
year = "2011",
month = "5",
doi = "10.1093/jjco/hyr011",
language = "English",
volume = "41",
pages = "709--712",
journal = "Japanese Journal of Clinical Oncology",
issn = "0368-2811",
publisher = "Oxford University Press",
number = "5",

}

TY - JOUR

T1 - Evaluation of trastuzumab without chemotherapy as a post-operative adjuvant therapy in HER2-positive elderly breast cancer patients

T2 - Randomized controlled trial [RESPECT (N-SAS BC07)]

AU - Sawaki, Masataka

AU - Tokudome, Nahomi

AU - Mizuno, Toshiro

AU - Nakayama, Takahiro

AU - Taira, Naruto

AU - Bando, Hiroko

AU - Murakami, Shigeru

AU - Yamamoto, Yutaka

AU - Kashiwaba, Masahiro

AU - Iwata, Hiroji

AU - Uemura, Yukari

AU - Ohashi, Yasuo

PY - 2011/5

Y1 - 2011/5

N2 - 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.

AB - 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.

KW - Breast cancer

KW - Elderly

KW - HER2/neu

KW - Monotherapy

KW - Phase III

KW - Trastuzumab

UR - http://www.scopus.com/inward/record.url?scp=79955869429&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79955869429&partnerID=8YFLogxK

U2 - 10.1093/jjco/hyr011

DO - 10.1093/jjco/hyr011

M3 - Article

C2 - 21355003

AN - SCOPUS:79955869429

VL - 41

SP - 709

EP - 712

JO - Japanese Journal of Clinical Oncology

JF - Japanese Journal of Clinical Oncology

SN - 0368-2811

IS - 5

M1 - hyr011

ER -