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

doi:10.1093/jjco/hyr011

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)]

Jpn J Clin Oncol. 2011 May;41(5):709-12. doi: 10.1093/jjco/hyr011. Epub 2011 Feb 24.

Authors

Masataka Sawaki¹, Nahomi Tokudome, Toshiro Mizuno, Takahiro Nakayama, Naruto Taira, Hiroko Bando, Shigeru Murakami, Yutaka Yamamoto, Masahiro Kashiwaba, Hiroji Iwata, Yukari Uemura, Yasuo Ohashi

Affiliation

¹ 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

PMID: 21355003
DOI: 10.1093/jjco/hyr011

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.

Publication types

Clinical Trial, Phase III
Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Antibodies, Monoclonal / economics
Antibodies, Monoclonal / therapeutic use*
Antibodies, Monoclonal, Humanized
Antineoplastic Agents / economics
Antineoplastic Agents / therapeutic use*
Antineoplastic Combined Chemotherapy Protocols / economics
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Biomarkers, Tumor / analysis*
Breast Neoplasms / drug therapy*
Breast Neoplasms / economics
Breast Neoplasms / surgery*
Carcinoma, Ductal, Breast / drug therapy*
Carcinoma, Ductal, Breast / economics
Carcinoma, Ductal, Breast / surgery*
Chemotherapy, Adjuvant
Cost-Benefit Analysis
Cyclophosphamide / administration & dosage
Disease-Free Survival
Docetaxel
Doxorubicin / administration & dosage
Epirubicin / administration & dosage
Female
Fluorouracil / administration & dosage
Health Status
Humans
Kaplan-Meier Estimate
Methotrexate / administration & dosage
Paclitaxel / administration & dosage
Prospective Studies
Quality of Life
Receptor, ErbB-2 / analysis*
Taxoids / administration & dosage
Trastuzumab
Treatment Outcome

Substances

Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antineoplastic Agents
Biomarkers, Tumor
Taxoids
Docetaxel
Epirubicin
Doxorubicin
Cyclophosphamide
ERBB2 protein, human
Receptor, ErbB-2
Trastuzumab
Paclitaxel
Fluorouracil
Methotrexate