Evidence map›Paper›PMID 34810217›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Trastuzumab Plus Endocrine Therapy or Chemotherapy as First-line Treatment for Patients with Hormone Receptor-Positive and HER2-Positive Metastatic Breast Cancer (SYSUCC-002).

Xin Hua, Xi-Wen Bi, Jian-Li Zhao, Yan-Xia Shi, Ying Lin, Zhi-Yong Wu, Yuan-Qi Zhang, Le-Hong Zhang, An-Qing Zhang, Heng Huang and 12 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01950182 (A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 3% of its field
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.

NCT01950182 phase3completednot on this map

A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype

TypeinterventionalSponsorSun Yat-sen UniversityRan2013 to 2020Enrolled392ConditionsBreast CancerArmsEndocrine therapy combined with trastuzumab, Chemotherapy combined with trastuzumab
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  6. Review
  7. Article
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  9. Chinese expert consensus on endocrine therapy for breast cancer (2026 edition).Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
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  11. Review
  12. Article
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  19. Breast cancer: pathogenesis and treatments.Signal transduction and targeted therapy · 2025
    Review
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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

22 authors at 7 institutions in 1 country.

Xin Hua *Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Xi-Wen Bi *Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Jian-Li Zhao *Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Yan-Xia Shi *Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Ying LinThyroid and Breast Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
Zhi-Yong WuDepartment of Oncology Surgery, Diagnosis and Treatment Center of Breast Diseases, Affiliated Shantou Hospital, Sun Yat-sen University, Shantou, China.
Yuan-Qi ZhangDepartment of Vascular Surgery, Affiliated Hospital of Guangdong Medical College, Zhanjiang, China.
Le-Hong ZhangDepartment of Breast Oncology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
An-Qing ZhangDepartment of Breast Oncology, Maternal and Child Health Care Hospital of Guangdong Province, Guangzhou, China.
Heng HuangDepartment of Breast Oncology, Lianjiang Pepole's Hospital, Lianjiang, China.
Xin-Mei LiuDepartment of Breast Oncology, Haikou People's Hospital, Haikou, China.
Fei XuDepartment of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Ying GuoDepartment of Good Clinical Practice, the State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Wen XiaDepartment of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Ruo-Xi HongDepartment of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Kui-Kui JiangDepartment of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Cong XueDepartment of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Xin AnDepartment of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Yong-Yi ZhongDepartment of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Shu-Sen Wang *Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.ORCID 0000-0003-0139-5780
Jia-Jia Huang *Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Zhong-Yu Yuan *Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Sun Yat-sen University · CNGuangdong Medical College · CNGuangdong Province Women and Children Hospital · CNHaikou City People's Hospital · CNQujiang People's Hospital · CNSecond Affiliated Hospital of Guangzhou Medical University · CNShantou University · CN

Funding

Natural Science Foundation of Guangdong Province 2019A151011781Sci-Tech Project Foundation of Guangzhou City 202002020033the cultivation foundation for the junior teachers in Sun Yat-sen University 20ykpy164
6 · The paper itself

Abstract

purposeThere is no research evidence demonstrate which is the better partner strategy, endocrine therapy or chemotherapy, to combine with anti-HER2 therapy as the first-line management of hormone receptor (HR)-positive (HR+) and HER2-positive (HER2+) metastatic breast cancer (MBC). We wished to ascertain if trastuzumab plus endocrine therapy is noninferior to trastuzumab plus chemotherapy. PATIENTS AND

methodsWe conducted an open-label, noninferiority, phase III, randomized, controlled trial (NCT01950182) at nine hospitals in China. Participants, stratified by previous adjuvant endocrine therapy and disease status (recurrent disease vs. de novo metastasis), were assigned randomly (1:1) to receive trastuzumab plus endocrine therapy (per investigator's choice of oestrogen-receptor modulators or aromatase inhibitor, with/without concurrent ovarian suppression) or chemotherapy (per investigator's choice of taxanes, capecitabine, or vinorelbine). The primary endpoint was progression-free survival (PFS) with a noninferiority upper margin of 1.35 for the HR. The intention-to-treat population was used in primary and safety analyses.

resultsA total of 392 patients were enrolled and assigned randomly to receive trastuzumab plus endocrine therapy (ET group, n = 196) or trastuzumab plus chemotherapy (CT group, n = 196). After a median follow-up of 30.2 months [interquartile range (IQR) 15.0-44.7], the median PFS was 19.2 months [95% confidence interval (CI), 16.7-21.7)] in the ET group and 14.8 months (12.8-16.8) in the CT group (hazard ratio, 0.88; 95% CI, 0.71-1.09; Pnoninferiority < 0.0001). A significantly higher prevalence of toxicity was observed in the CT group compared with the ET group.

conclusionsTrastuzumab plus endocrine therapy was noninferior to trastuzumab plus chemotherapy in patients with HR+HER2+ MBC.

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHumansTrastuzumabTreatment OutcomeAromatase InhibitorsErb-b2 Receptor Tyrosine KinasesTrastuzumab

Identifiers

PMID34810217
PMCPMC9377763
OpenAlexW3215853140

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.