Evidence map›Paper›PMID 42098463›Full record

Trial reportInternational journal of clinical oncology2026

The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in Chinese patients with HER2-positive early breast cancer: primary analysis of the phase III, randomized FDChina study.

Tao Huang, Zhimin Fan, Yongsheng Wang, Xi Yan, Hongjian Yang, Shu Wang, Da Pang, Huiping Li, Haibo Wang, Cuizhi Geng and 7 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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.

Tao HuangBreast and Thyroid Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Zhimin FanDepartment of Breast Surgery, Jilin University, Changchun, 130021, China.
Yongsheng WangBreast Cancer Center, Shandong Cancer Hospital, Jinan, 250117, China.
Xi YanMedical Oncology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Hongjian YangBreast Surgery, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
Shu WangBreast Center, Peking University People's Hospital, Beijing, 100044, China.
Da PangDepartment of Breast Surgery, Harbin Medical University Cancer Hospital, Harbin, 150040, China.
Huiping LiThe Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital and Institute, Beijing, 100142, China.
Haibo WangDepartment of Breast Cancer, Affiliated Hospital of Qingdao University, Qingdao, 266000, China.
Cuizhi GengBreast Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050035, China.
Liang HuangDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Yaqing SunProduct Development China, Roche (China) Holding Co. Ltd, Shanghai, 201203, China.
Bei WangClinical Pharmacology, Genentech Inc., San Francisco, CA, 94080, USA.
Guofang SunProduct Development China, Roche (China) Holding Co. Ltd, Shanghai, 201203, China.
Asna SiddiquiProduct Development Clinical Oncology, Roche Products Limited, Welwyn Garden City, AL7 1TW, UK.
Eleonora RestucciaProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, 4070, Switzerland.
Zhimin ShaoBreast Cancer, Fudan University Shanghai Cancer Center, Shanghai, 200032, China. zhimingshao@fudan.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeoadjuvant fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) demonstrated non-inferior cycle 7 pertuzumab and trastuzumab serum trough concentrations (C

methodsPatients received four doxorubicin (60 mg/m

resultsThe lower bounds of the 90% confidence intervals of pertuzumab and trastuzumab cycle 7 geometric mean ratios (0.99 and 1.44, respectively) exceeded the pre-specified non-inferiority margin (0.8). tpCR rates were 55.6% for PH FDC SC vs. 56.4% for P + H IV. Grade ≥ 3 adverse events occurred in 72% vs. 69% of patients.

conclusionThe study met the co-primary endpoints of non-inferiority of cycle 7 serum C

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesTrastuzumabAdultAgedCyclophosphamideDocetaxelDoxorubicinEast Asian PeopleFemaleHumansInjections, SubcutaneousMiddle AgedNeoadjuvant TherapyAntibodies, Monoclonal, HumanizedCyclophosphamideDocetaxelDoxorubicinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumabChinese patientsFixed-dose combinationHER2-positive early breast cancerPertuzumabSubcutaneousTrastuzumab

Identifiers

PMID42098463
PMCPMC13303565

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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 Socratic graph.