Evidence map›Paper›PMID 39825877›Full record

Trial reportCancer communications (London, England)2025

Efficacy and safety of KN026 and docetaxel for HER2-positive breast cancer: a phase II clinical trial.

Jianli Ma, Jingxuan Wang, Ting Xu, Quchang Ouyang, Xiaojia Wang, Jingfen Wang, Lu Gan, Zhong Ouyang, Daren Lin, Tao Sun and 11 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer communications (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
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 MaDepartment of Radiotherapy, Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang, P. R. China.
Jingxuan WangDepartment of Medical Oncology, Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang, P. R. China.
Ting XuDepartment of President, Jiangsu Alphamab Biopharmaceuticals Co. Ltd., Suzhou, Jiangsu, P. R. China.
Quchang OuyangBreast Internal Medicine Department, Hunan Cancer Hospital, Changsha, Hunan, P. R. China.
Xiaojia WangDepartment of Breast Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, P. R. China.ORCID 0000-0002-7005-0842
Jingfen WangDepartment of Breast Medical Oncology, Linyi Cancer Hospital, Linyi, Shandong, P. R. China.
Lu GanDepartment of Oncology, The Hospital Group of the First Affiliated Hospital of Chongqing Medical University, Chongqing, P. R. China.
Zhong OuyangDepartment of Breast Surgery, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, P. R. China.
Daren LinDepartment of Oncology, Jiangmen Central Hospital, Jiangmen, Guangdong, P. R. China.
Tao SunDepartment of Breast Medical Oncology, Liaoning Cancer Hospital, Shenyang, Liaoning, P. R. China.
Changping ShanDepartment of Oncology, Affiliated Hospital of Jining Medical University, Jining, Liaoning, P. R. China.
Herui YaoBreast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.
Baochun ZhangDepartment of Breast Medicine, Nantong Cancer Hospital, Nantong, Jiangsu, P. R. China.
Zhengguang LiDepartment of Oncology, Chengdu Seventh People's Hospital, Chengdu, Sichuan, P. R. China.
Zhixiang ZhuangDepartment of Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, P. R. China.
Ying LuDepartment of Oncology, Liuzhou Worker's Hospital, Liuzhou, Guangxi, P. R. China.
Hongwei YangDepartment of Breast and Thyroid Surgery, Suining Central Hospital, Suining, Sichuan, P. R. China.
Jian HuangDepartment of Breast Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, P. R. China.
Xingwang YangDepartment of General Surgery, Zibo Municipal Hospital, Zibo, Shandong, P. R. China.
Hongmei SunDepartment of Medical Oncology, Jiamusi Cancer Tuberculosis Hospital, Jiamusi, Heilongjiang, P. R. China.
Qingyuan ZhangDepartment of Medical Oncology, Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang, P. R. China.ORCID 0000-0001-8116-5293

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe standard first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive recurrent/metastatic breast cancer currently includes pertuzumab plus trastuzumab and docetaxel. This study aimed to evaluate the effectiveness of KN026, an anti-HER2 bispecific antibody, plus docetaxel in first-line treatment of HER2-positive recurrent/metastatic breast cancer.

methodsThis open-label, single-arm, phase II study enrolled patients with HER2-positive recurrent/metastatic breast cancer in 19 centers across China from December 30, 2019 to May 27, 2021. Patients were administered KN026 (30 mg/kg) plus docetaxel (75 mg/m

resultsA total of 57 patients were included. In the efficacy analysis set of 55 patients, the ORR was 76.4% (95% confidence interval [CI], 63.0%-86.8%), and the CBR was 85.5% (95% CI, 73.3%-93.5%). The median DOR was not reached (95% CI, 20.7 months-not reached). In the safety set of 57 patients, the median PFS was 27.7 months (95% CI, 18.0 months-not reached). The median OS was not reached, with OS rates at 12, 24 and 30 months of 93.0%, 84.1% and 78.5%, respectively. Grade ≥3 treatment-emergent adverse events (AEs) were detected in 36 (63.2%) patients. No deaths were attributed to KN026 or docetaxel.

conclusionKN026 plus docetaxel showed promising efficacy and a manageable safety profile in first-line treatment of HER2-positive recurrent/metastatic breast cancer.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDocetaxelErb-b2 Receptor Tyrosine KinasesNeoplasm Recurrence, LocalAdultAgedFemaleHumansMiddle AgedTreatment OutcomeDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine Kinasesanti‐HER‐2 Bispecific AntibodyAntineoplastic AgentsBreast NeoplasmsDocetaxelPhase II Clinical Trial

Identifiers

PMID39825877
PMCPMC11999887

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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.