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Clinical Trial
. 2025 May 10;43(14):1631-1637.
doi: 10.1200/JCO-24-01673. Epub 2025 Jan 24.

Pertuzumab Retreatment for Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced/Metastatic Breast Cancer (PRECIOUS Study): Final Overall Survival Analysis

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

Pertuzumab Retreatment for Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced/Metastatic Breast Cancer (PRECIOUS Study): Final Overall Survival Analysis

Yutaka Yamamoto et al. J Clin Oncol. .

Erratum in

Abstract

In the primary analysis of the open-label phase III PRECIOUS study, pertuzumab retreatment combined with trastuzumab plus chemotherapy of physician's choice (PTC) significantly improved investigator-assessed progression-free survival (PFS) compared with trastuzumab plus physician's choice chemotherapy (TC) in patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced/metastatic breast cancer (LA/mBC). Here, we report final overall survival (OS) at the median follow-up of 25.8 months. Patients who have previously received pertuzumab-containing regimens as first-/second-line treatment for LA/mBC were randomly assigned 1:1 to two groups, PTC group (n = 110) and TC group (n = 109). Median OS was longer in the PTC group (median OS 36.2 v 26.5 months; hazard ratio [HR], 0.73 [one side 95% CI upper limit, 0.97]). Updated median investigator-assessed PFS (5.5 v 4.2 months; HR, 0.81 [one side 95% CI upper limit, 1.02]) were also better in the PTC group. Median PFS by independent review did not show the difference between the two groups (4.4 v 4.4 months; HR, 1.03 [one side 95% CI upper limit, 1.36]). These findings suggest that dual HER2 blockade with pertuzumab plus trastuzumab could contribute to improving OS in patients who have previously been treated with pertuzumab-containing regimens for HER2-positive LA/mBC.

Trial registration: ClinicalTrials.gov NCT02514681.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Figures

FIG 1.
FIG 1.
Patient disposition. IC, informed consent; ITT, intention-to-treat; PTC, pertuzumab, trastuzumab, and chemotherapy; TC, trastuzumab plus chemotherapy.
FIG 2.
FIG 2.
Kaplan-Meier OS curves for the intent-to-treat population. CT, computed tomography; F/U, follow-up; HR, hazard ratio; OS, overall survival; PER, pertuzumab; PTC, pertuzumab, trastuzumab and chemotherapy; TC, trastuzumab plus chemotherapy; TRA, trastuzumab.
FIG 3.
FIG 3.
Forest plot of prespecified subgroup analysis for overall survival. aCox proportional hazard model without adjusting for stratification factors. ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; PTC, pertuzumab, trastuzumab, and chemotherapy; TC, trastuzumab plus chemotherapy.
FIG 4.
FIG 4.
Kaplan-Meier survival curves for (A) updated investigator-assessed progression-free survival in the intent-to-treat population and (B) independent reviewer-assessed PFS in the centrally reviewed population. F/U, follow-up; HR, hazard ratio; PFS, progression-free survival; PTC, pertuzumab, trastuzumab, and chemotherapy; TC, trastuzumab plus chemotherapy
See this image and copyright information in PMC

References

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