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Clinical Trial
. 2022 Sep;113(9):3169-3179.
doi: 10.1111/cas.15474. Epub 2022 Jul 23.

Pertuzumab retreatment for HER2-positive advanced breast cancer: A randomized, open-label phase III study (PRECIOUS)

Yutaka Yamamoto  1 , Hiroji Iwata  2 , Naruto Taira  3 , Norikazu Masuda  4 , Masato Takahashi  5 , Tetsuhiro Yoshinami  6   7 , Takayuki Ueno  8 , Tatsuya Toyama  9 , Takashi Yamanaka  10 , Toshimi Takano  11   12 , Masahiro Kashiwaba  13   14 , Koichiro Tsugawa  15 , Yoshie Hasegawa  16 , Kenji Tamura  17   18 , Hiroshi Tada  19 , Fumikata Hara  12   20 , Tomomi Fujisawa  21 , Naoki Niikura  22 , Shigehira Saji  23 , Satoshi Morita  24 , Masakazu Toi  25 , Shinji Ohno  26
Affiliations
Clinical Trial

Pertuzumab retreatment for HER2-positive advanced breast cancer: A randomized, open-label phase III study (PRECIOUS)

Yutaka Yamamoto et al. Cancer Sci. 2022 Sep.

Abstract

No standard options existed for human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer that progresses after second-line trastuzumab emtansine therapy before 2020. The purpose of this study was to examine the efficacy of pertuzumab retreatment after disease progression following pertuzumab-containing therapy for HER2-positive locally advanced or metastatic breast cancer for the first time. This randomized, open-label, multicenter phase III trial was undertaken in 93 sites in Japan. Eligible patients with HER2-positive breast cancer who had received pertuzumab, trastuzumab, and chemotherapy as first- and/or second-line therapy were randomly assigned (1:1) to: (i) pertuzumab, trastuzumab, and physician's choice chemotherapy (PTC), or (ii) trastuzumab and physician's choice chemotherapy (TC). The primary end-point was investigator-assessed progression-free survival (PFS). Between August 1, 2015 and December 31, 2018, 219 patients were randomized to PTC (n = 110) or TC (n = 109). Median follow-up was 14.2 months (interquartile range, 9.0-22.2), and median PFS was 5.3 months (95% confidence interval [CI], 4.0-6.6) with PTC and 4.2 months (95% CI, 3.2-4.8) with TC (stratified hazard ratio 0.76 [95% CI upper limit 0.967]; p = 0.022). Progression-free survival was improved by adding pertuzumab in all prespecified subgroups. The PTC arm showed a trend towards better overall survival and duration of response, but similar objective response and health-related quality of life. The incidence of treatment-related adverse events was similar between groups except for diarrhea. Pertuzumab retreatment contributes to disease control for HER2-positive locally advanced or metastatic breast cancer previously treated with pertuzumab-containing regimens.

Keywords: HER2-positive; advanced breast cancer; heavily pretreated; pertuzumab; trastuzumab.

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Figures

FIGURE 1
FIGURE 1
Selection of 219 women with HER2‐positive advanced breast cancer treated with pertuzumab (PER) + trastuzumab (TRA) + chemotherapy (CT) (PTC) or TRA + CT (TC). FAS, full analysis set; IC, informed consent; ITT, intention‐to‐treat; LA/MBC, locally advanced/metastatic breast cancer
FIGURE 2
FIGURE 2
Survival among 219 women with HER2‐positive advanced breast cancer treated with pertuzumab + trastuzumab + chemotherapy (PTC) or trastuzumab + chemotherapy (TC). (A) Progression‐free survival assessed by investigators (intention‐to‐treat [ITT] population). (B) Progression‐free survival in patients treated with trastuzumab emtansine as the latest regimen (ITT population). (C) Overall survival (ITT population). CI, confidence interval; HR, hazard ratio
FIGURE 3
FIGURE 3
Prespecified progression‐free survival subgroup analysis among 219 women with HER2‐positive advanced breast cancer treated with pertuzumab (PER) + trastuzumab + chemotherapy (PTC) or trastuzumab + chemotherapy (TC). CI, confidence interval; CT, chemotherapy; HR, hazard ratio; LA/MBC, locally advanced/metastatic breast cancer; PS, performance status
FIGURE 4
FIGURE 4
Time to deterioration in Functional Assessment of Cancer Therapy – Breast Trial Outcome Index (intention‐to‐treat population) among women with HER2‐positive advanced breast cancer treated with pertuzumab + trastuzumab + chemotherapy (PTC) or trastuzumab + chemotherapy (TC). CI, confidence interval; HR, hazard ratio
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