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

Yutaka Yamamoto, Hiroji Iwata, Takayuki Ueno, Naruto Taira, Masahiro Kashiwaba, Masato Takahashi, Hiroshi Tada, Koichiro Tsugawa, Tatsuya Toyama, Naoki Niikura, Fumikata Hara, Tomomi Fujisawa, Tetsuhiro Yoshinami, Shigehira Saji, Toshimi Takano, Norikazu Masuda, Satoshi Morita, Masakazu Toi, Shinji Ohno

Research output: Contribution to journalArticle

Abstract

The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, open-label 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.

Original languageEnglish
Pages (from-to)855-859
Number of pages5
JournalJapanese Journal of Clinical Oncology
Volume48
Issue number9
DOIs
Publication statusPublished - Sep 1 2018

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Retreatment
Japan
Breast Neoplasms
Disease-Free Survival
Drug Therapy
Research
Quality of Life
Research Personnel
Observation
Safety
Survival
Trastuzumab
pertuzumab
Therapeutics

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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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. / Yamamoto, Yutaka; Iwata, Hiroji; Ueno, Takayuki; Taira, Naruto; Kashiwaba, Masahiro; Takahashi, Masato; Tada, Hiroshi; Tsugawa, Koichiro; Toyama, Tatsuya; Niikura, Naoki; Hara, Fumikata; Fujisawa, Tomomi; Yoshinami, Tetsuhiro; Saji, Shigehira; Takano, Toshimi; Masuda, Norikazu; Morita, Satoshi; Toi, Masakazu; Ohno, Shinji.

In: Japanese Journal of Clinical Oncology, Vol. 48, No. 9, 01.09.2018, p. 855-859.

Research output: Contribution to journalArticle

Yamamoto, Y, Iwata, H, Ueno, T, Taira, N, Kashiwaba, M, Takahashi, M, Tada, H, Tsugawa, K, Toyama, T, Niikura, N, Hara, F, Fujisawa, T, Yoshinami, T, Saji, S, Takano, T, Masuda, N, Morita, S, Toi, M & Ohno, S 2018, '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', Japanese Journal of Clinical Oncology, vol. 48, no. 9, pp. 855-859. https://doi.org/10.1093/jjco/hyy097
Yamamoto, Yutaka ; Iwata, Hiroji ; Ueno, Takayuki ; Taira, Naruto ; Kashiwaba, Masahiro ; Takahashi, Masato ; Tada, Hiroshi ; Tsugawa, Koichiro ; Toyama, Tatsuya ; Niikura, Naoki ; Hara, Fumikata ; Fujisawa, Tomomi ; Yoshinami, Tetsuhiro ; Saji, Shigehira ; Takano, Toshimi ; Masuda, Norikazu ; Morita, Satoshi ; Toi, Masakazu ; Ohno, Shinji. / 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. In: Japanese Journal of Clinical Oncology. 2018 ; Vol. 48, No. 9. pp. 855-859.
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abstract = "The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, open-label 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.",
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AU - Iwata, Hiroji

AU - Ueno, Takayuki

AU - Taira, Naruto

AU - Kashiwaba, Masahiro

AU - Takahashi, Masato

AU - Tada, Hiroshi

AU - Tsugawa, Koichiro

AU - Toyama, Tatsuya

AU - Niikura, Naoki

AU - Hara, Fumikata

AU - Fujisawa, Tomomi

AU - Yoshinami, Tetsuhiro

AU - Saji, Shigehira

AU - Takano, Toshimi

AU - Masuda, Norikazu

AU - Morita, Satoshi

AU - Toi, Masakazu

AU - Ohno, Shinji

PY - 2018/9/1

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N2 - The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, open-label 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.

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