A randomized, open-label, Phase III trial of pertuzumab retreatment in HER2-positive locally advanced/metastatic breast cancer patients previously treated with pertuzumab, trastuzumab and chemotherapy: the Japan Breast Cancer Research Group-M05 PRECIOUS study

被引：5

作者：

Yamamoto, Yutaka ^{[1
]}

Iwata, Hiroji ^{[2
]}

Ueno, Takayuki ^{[3
]}

Taira, Naruto ^{[4
]}

Kashiwaba, Masahiro ^{[5
]}

Takahashi, Masato ^{[6
]}

Tada, Hiroshi ^{[7
]}

Tsugawa, Koichiro ^{[8
]}

Toyama, Tatsuya ^{[9
]}

Niikura, Naoki ^{[10
]}

Hara, Fumikata ^{[11
]}

Fujisawa, Tomomi ^{[12
]}

Yoshinami, Tetsuhiro ^{[13
]}

Saji, Shigehira ^{[14
]}

Takano, Toshimi ^{[15
]}

Masuda, Norikazu ^{[16
]}

Morita, Satoshi ^{[17
]}

Toi, Masakazu ^{[18
]}

Ohno, Shinji ^{[19
]}

机构：

[1] Kumamoto Univ, Grad Sch Med Sci, Dept Breast & Endocrine Surg, Kumamoto, Japan

[2] Aichi Canc Ctr Hosp, Dept Breast Oncol, Nagoya, Aichi, Japan

[3] Kyorin Univ Hosp, Dept Breast Surg, Tokyo, Japan

[4] Okayama Univ Hosp, Dept Breast & Endocrine Surg, Okayama, Japan

[5] Breastpia Miyazaki Hosp, Dept Breast Surg, Miyazak, Japan

[6] Natl Hosp Org Hokkaido Canc Ctr, Dept Breast Surg, Sapporo, Hokkaido, Japan

[7] Tohoku Univ, Grad Sch Med, Dept Breast & Endocrine Surg Oncol, Sendai, Miyagi, Japan

[8] St Marianna Univ, Dept Surg, Div Breast & Endocrine Surg, Sch Med Hosp, Kawasaki, Kanagawa, Japan

[9] Nagoya City Univ, Dept Breast Surg, Grad Sch Med Sci, Nagoya, Aichi, Japan

[10] Tokai Univ, Dept Breast & Endocrine Surg, Sch Med, Isehara, Kanagawa, Japan

[11] Natl Hosp Org Shikoku Canc Ctr, Dept Breast Oncol, Matsuyama, Ehime, Japan

[12] Gunma Prefectural Canc Ctr, Dept Breast Oncol, Ohta, Gunma, Japan

[13] Osaka Int Canc Inst, Dept Clin Oncol, Osaka, Japan

[14] Fukushima Med Univ, Dept Med Oncol, Fukushima, Japan

[15] Toranomon Gen Hosp, Dept Med Oncol, Tokyo, Japan

[16] Natl Hosp Org Osaka Natl Hosp, Breast Oncol, Dept Surg, Osaka, Japan

[17] Kyoto Univ, Dept Biomed Stat & Bioinformat, Grad Sch Med, Kyoto, Japan

[18] Kyoto Univ, Dept Surg Breast Surg, Grad Sch Med, Kyoto, Japan

[19] Canc Inst Hosp JFCR, Breast Oncol Ctr, Tokyo, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2018年 / 48卷 / 09期

关键词：

breast cancer; pertuzumab; retreatment; DOCETAXEL;

D O I：

10.1093/jjco/hyy097

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, openlabel Phase III study to determine if retreatment with pertuzumab is more effective than conventional treatment in HER2-positive locally advanced (LA)/metastatic breast cancer (MBC) patients previously treated with pertuzumab, trastuzumab and chemotherapy. Patients are randomized 1:1 into chemotherapy plus trastuzumab with or without pertuzumab groups. The latest regimen before enrollment did not include pertuzumab, and the number of previous chemotherapy regimens for LA/MBC did not exceed three. The primary endpoint is investigator-assessed progression-free survival. Secondary endpoints include independent reviewer-assessed progression-free survival, progression-free survival in patients treated with trastuzumab emtansine as the latest regimen, response rate, response duration, overall survival, safety and health-related quality of life. Target accrual is 370 patients, allowing the observation of 325 events, yielding an 80% power for detection of a hazard ratio of 0.739 with a one-sided 5% level of significance.

引用

页码：855 / 859

页数：5

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