Evidence map›Paper›PMID 39712455›Full record

ArticleMedComm2025

Combined pyrotinib and fulvestrant for hormone receptor-positive and HER2-positive metastatic breast cancer: A multicenter, single-arm, phase II trial.

Jianli Zhao, Yunfang Yu, Wei Ren, Linxiaoxiao Ding, Yongjian Chen, Peng Yuan, Jian Yue, Yaping Yang, Guorong Zou, Tao Chen and 11 more

Registry-linked trialAbstract read
In one paragraph

Article in MedComm, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04034589 (Phase II Study of Pyrotinib in Combination With Fulvestrant in Patients With Human Epidermal Growth Factor Receptor 2), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT04034589 phase2unknown statusnot on this map

Phase II Study of Pyrotinib in Combination With Fulvestrant in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive,Hormone Receptor(HR)-Positive Metastatic Breast Cancer

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2019 to 2022Enrolled46ConditionsMetastatic Breast CancerArmsPyrotinib combined with fulvestrant
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. 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

21 authors.

Jianli ZhaoGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Yunfang YuGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.ORCID https://orcid.org/0000-0003-2579-6220
Wei RenGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Linxiaoxiao DingGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Yongjian ChenDermatology and Venereology Division Department of Medicine Solna Center for Molecular Medicine Karolinska Institute Stockholm Stockholm Sweden.
Peng YuanDepartment of VIP Medical Services National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China.
Jian YueDepartment of VIP Medical Services National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China.
Yaping YangGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Guorong ZouDepartment of Medical Oncology the Affiliated Panyu Central Hospital of Guangzhou Medical University Guangzhou Guangdong China.
Tao ChenGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Jie ChaiGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Li ZhangGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Wenjing WuGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Yinduo ZengGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Xiujuan GuiGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Yangyang CaiGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Simin LuoGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Zhongyu YuanDepartment of Medical Oncology Sun Yat-Sen University Cancer Center the State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine Guangzhou Guangdong China.
Kang ZhangFaculty of Medicine Macau University of Science and Technology Taipa Macao PR China.
Herui YaoGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.
Ying WangGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter, single-arm, phase II clinical trial (NCT04034589) evaluated the efficacy and safety of pyrotinib combined with fulvestrant in patients with HR-positive/HER2-positive metastatic breast cancer who had experienced trastuzumab treatment failure. A total of 46 patients were enrolled, receiving pyrotinib orally once daily and fulvestrant intramuscularly on days 1 and 15 of cycle 1, followed by monthly doses on day 1. The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. The median PFS was 18.2 months (95% CI, 11.9-31.1) overall, 19.5 months (95% CI, 10.6-NA) for those receiving the combination as first-line therapy, and 18.4 months (95% CI, 16.7-NA) for patients with brain metastases. Median OS was not reached, with a 3-year OS rate of 75.2% (95% CI, 62.8-90.2%). The ORR was 32.5%, and the DCR was 97.5%. Responses were observed in patients with low tumor mutation burden and

Identifiers

PMID39712455
PMCPMC11661908

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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.