Evidence map›Paper›PMID 40178527›Full record

Trial reporteLife2025

Pyrotinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (PERSIST): A multicenter phase II trial.

Feilin Cao, Zhaosheng Ma, Zenggui Wu, Weizhu Wu, Ouchen Wang, Binbin Cui, Xiaotao Zhu, Jing Hao, Xiaochun Ji, Zhanwen Li and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in eLife, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05880927 (Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05880927 phase2unknown statusnot on this map

Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial

TypeinterventionalSponsorTaizhou HospitalRan2019 to 2025Enrolled150ConditionsBreast CancerArmsPyrotinib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Feilin Cao *Department of Thyroid and Breast Surgery, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, China.ORCID https://orcid.org/0009-0002-5083-1462
Zhaosheng Ma *Department of Thyroid and Breast Surgery, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, China.
Zenggui Wu *Department of Thyroid and Breast Surgery, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, China.
Weizhu WuDepartment of Thyroid and Breast Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo, China.
Ouchen WangDepartment of Breast Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Binbin Cui *Department of Thyroid and Breast Surgery, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, China.
Xiaotao Zhu *Department of Thyroid and Breast Surgery, Jinhua Municipal Central Hospital, Jinhua, China.
Jing Hao *Department of Thyroid and Breast Surgery, Yiwu Central Hospital, Jinhua, China.
Xiaochun Ji *Department of Thyroid and Breast Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo, China.
Zhanwen Li *Department of Breast Surgery, Ningbo Women and Children's Hospital, Ningbo, China.
Deyou TaoDepartment of Thyroid and Breast Surgery, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, China.
Qingjing Feng *Department of Breast Surgery, Yiwu Maternity and Children Hospital, Jinhua, China.
Wei Lin *Department of Surgical Oncology, Quzhou People's Hospital, Quzhou, China.
Dongbo Shi *Department of Breast Surgery, The First Affiliated Hospital of Ningbo University, Ningbo, China.
Jingde Shu *Department of Surgical Oncology, Quzhou People's Hospital, Quzhou, China.
Jichun ZhouDepartment of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Shifen HuangDepartment of Thyroid and Breast Surgery, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Approximately one-third of patients with HER2-positive breast cancer experienced recurrence within 10 years after receiving 1 year of adjuvant trastuzumab. The ExteNET study showed that 1 year of extended adjuvant neratinib after trastuzumab-based adjuvant therapy could reduce invasive disease-free survival (iDFS) events compared with placebo. This study investigated the efficacy and safety of pyrotinib, an irreversible pan-HER receptor tyrosine kinase inhibitor, after trastuzumab-based adjuvant therapy in patients with high-risk, HER2-positive early or locally advanced breast cancer. Methods: This multicenter phase II trial was conducted at 23 centers in China. After enrollment, patients received 1 year of extended adjuvant pyrotinib (400 mg/day), which should be initiated within 6 months after the completion of 1-year adjuvant therapy (trastuzumab alone or plus pertuzumab). The primary endpoint was 2-year iDFS rate. Results: Between January 2019 and February 2022, 141 eligible women were enrolled and treated. As of October 10, 2022, the median follow-up was 24 (interquartile range, 18.0-34.0) months. The 2-year iDFS rate was 94.59% (95% confidence interval [CI]: 88.97-97.38) in all patients, 94.90% (95% CI: 86.97-98.06) in patients who completed 1-year treatment, 90.32% (95% CI: 72.93-96.77) in patients who completed only 6-month treatment, 96.74% (95% CI: 87.57-99.18) in the hormone receptor (HR)-positive subgroup, 92.77% (95% CI: 83.48-96.93) in the HR-negative subgroup, 96.88% (95% CI: 79.82-99.55) in the lymph node-negative subgroup, 93.85% (95% CI: 86.81-97.20) in the lymph node-positive subgroup, 97.30% (95% CI: 82.32-99.61) in patients with adjuvant trastuzumab plus pertuzumab, and 93.48% (95% CI: 86.06-97.02) in patients with adjuvant trastuzumab. The most common adverse events were diarrhea (79.4%), fatigue (36.9%), lymphocyte count decreased (36.9%), nausea (33.3%), and hand-foot syndrome (33.3%). Conclusions: Extended adjuvant pyrotinib administrated after trastuzumab-based adjuvant therapy showed promising efficacy in patients with high-risk HER2-positive breast cancer. The follow-up is ongoing to determine the long-term benefit. Funding: No external funding was received for this work. Clinical trial number: ClinicalTrials.gov: NCT05880927.

Indexed as

AcrylamidesAminoquinolinesBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesTrastuzumabAdultAgedChemotherapy, AdjuvantChinaFemaleHumansMiddle AgedTreatment OutcomeAcrylamidesAminoquinolinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespyrotinibTrastuzumabbreast cancerextended adjuvant therapyhuman epidermal growth factor receptor 2invasive disease-free survivalmedicinenonepyrotinib

Identifiers

PMID40178527
PMCPMC11968101

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.