TY - JOUR
T1 - A randomized phase III study comparing trastuzumab emtansine with trastuzumab, pertuzumab and docetaxel in elderly patients with advanced stage HER2-positive breast cancer
T2 - Japan Clinical Oncology Group Study (JCOG1607, HERB TEA study)
AU - Shimomura, Akihiko
AU - Tamura, Kenji
AU - Tanaka, Kiyo
AU - Mizutani, Tomonori
AU - Sasaki, Keita
AU - Sekino, Yuta
AU - Sawaki, Masataka
AU - Shien, Tadahiko
AU - Shibata, Taro
AU - Iwata, Hiroji
N1 - Funding Information:
This study has been supported in part by the National Cancer Center Research and Development Funds (29-A-3, 2020-J-3) and Japan Agency for Medical Research and Development under Grant Numbers 19ck0106440.
Publisher Copyright:
© 2021 Oxford University Press. All rights reserved.
PY - 2021/9/1
Y1 - 2021/9/1
N2 - The standard first-line treatment for patients with human epidermal growth factor 2-positive metastatic breast cancer is a combination therapy of trastuzumab, pertuzumab and docetaxel, and the standard second-line treatment is trastuzumab emtansine. However, it may be difficult for the elderly to maintain sufficient intensity of treatment due to severe adverse events of trastuzumab, pertuzumab and docetaxel. The aim of this trial is to confirm the non-inferiority of trastuzumab emtansine over trastuzumab, pertuzumab and docetaxel in terms of overall survival in elderly (65- year-old or more) patients with human epidermal growth factor 2-positive metastatic breast cancer. If improved overall survival and fewer toxicities are observed, trastuzumab emtansine may be a feasible new standard first-line treatment for elderly patients with human epidermal growth factor 2-positive metastatic breast cancer. A planned total 330 patients will be enrolled from 45 institutions over 6.5 years. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000030783.
AB - The standard first-line treatment for patients with human epidermal growth factor 2-positive metastatic breast cancer is a combination therapy of trastuzumab, pertuzumab and docetaxel, and the standard second-line treatment is trastuzumab emtansine. However, it may be difficult for the elderly to maintain sufficient intensity of treatment due to severe adverse events of trastuzumab, pertuzumab and docetaxel. The aim of this trial is to confirm the non-inferiority of trastuzumab emtansine over trastuzumab, pertuzumab and docetaxel in terms of overall survival in elderly (65- year-old or more) patients with human epidermal growth factor 2-positive metastatic breast cancer. If improved overall survival and fewer toxicities are observed, trastuzumab emtansine may be a feasible new standard first-line treatment for elderly patients with human epidermal growth factor 2-positive metastatic breast cancer. A planned total 330 patients will be enrolled from 45 institutions over 6.5 years. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000030783.
KW - HER2
KW - breast cancer
KW - metastatic
KW - randomized phase III trial
KW - trastuzumab emtansine
UR - http://www.scopus.com/inward/record.url?scp=85115330389&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85115330389&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyab101
DO - 10.1093/jjco/hyab101
M3 - Article
C2 - 34215870
AN - SCOPUS:85115330389
SN - 0368-2811
VL - 51
SP - 1471
EP - 1474
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
IS - 9
ER -
