Evidence map›Paper›PMID 41016944›Full record

Trial reportSignal transduction and targeted therapy2025

Tumor microenvironment delineates differential responders to trastuzumab emtansine in HER2-positive metastatic breast cancer patients previously treated with pyrotinib: an exploratory biomarker analysis of a phase II study (NJMU-BC02).

Hong Pan, Ji Wang, Yue Sun, Fanfan Li, Chang Sun, Mingduo Liu, Hong Xu, Jing Tao, Xinrui Mao, Cong Wang and 4 more

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

Trial report in Signal transduction and targeted therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06125834 (Trastuzumab Emtansine), 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.

NCT06125834 phase2unknown statusnot on this map

Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study

TypeinterventionalSponsorThe First Affiliated Hospital with Nanjing Medical UniversityRan2023 to 2026Enrolled36ConditionsAdvanced Breast Cancer, Objective Response Rate, Trastuzumab EmtansineArmsTrastuzumab Emtansine (T-DM1)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

14 authors.

Hong Pan *Department of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Ji Wang *Department of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Yue Sun *Department of Oncology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Fanfan Li *Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Chang Sun *Department of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Mingduo LiuDepartment of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Hong XuDepartment of Medical Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Jing TaoDepartment of General Surgery, The Fourth Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xinrui MaoDepartment of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Cong WangDepartment of Pathology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Shui WangDepartment of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Wei LiDepartment of Oncology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China. liwei1218@njmu.edu.cn.
Qiang DingDepartment of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China. dingqiang@njmu.edu.cn.
Wenbin ZhouDepartment of Breast Surgery, Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China. zhouwenbin@njmu.edu.cn.ORCID 0000-0003-1220-6797

Funding

National Natural Science Foundation of China (National Science Foundation of China) 81771953National Natural Science Foundation of China (National Science Foundation of China) 82303710
6 · The paper itself

Abstract

Trastuzumab emtansine (T-DM1) has been approved for the treatment of HER2-positive breast cancer. However, the efficacy of T-DM1 for patients after failure of pyrotinib and/or trastuzumab plus pertuzumab has not been clear. Additionally, no biomarker has been reported to predict the effect of T-DM1. In this multicenter phase II trial (NCT06125834), 36 participants with HER2-positive metastatic breast cancer were enrolled to receive T-DM1 therapy on a 21-day cycle until progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR). The secondary endpoints included the disease control rate (DCR), clinical benefit rate (CBR), progression-free survival (PFS), and toxicity. The primary endpoint was an ORR of 47.2% (17/36, 95% CI 30.4-64.5). The treatment exhibited a manageable toxicity profile. The DCR was 66.7% (24/36, 95% CI 49.0-81.4), and the CBR was 50.0% (18/36, 95% CI 32.9-67.1). The median PFS was 6.6 (95% CI 5.2-NA) months. Single-cell RNA sequencing revealed that the low cell cycle activity of cancer cells, activated macrophages and CD8+ T cells was associated with the good efficacy of T-DM1, which was validated in a neoadjuvant cohort. This study suggests that T-DM1 is effective with a measurable safety profile in patients with metastatic HER2-positive breast cancer after failure of pyrotinib and/or trastuzumab plus pertuzumab. Our preliminary findings suggest potential biomarkers that may help predict T-DM1 efficacy, generating hypotheses for novel therapeutic targets that may address T-DM1 resistance.

Indexed as

AcrylamidesAdo-Trastuzumab EmtansineAminoquinolinesBiomarkers, TumorBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesTumor MicroenvironmentAdultAgedFemaleHumansMiddle AgedNeoplasm MetastasisAcrylamidesAdo-Trastuzumab EmtansineAminoquinolinesBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine Kinasespyrotinib

Identifiers

PMID41016944
PMCPMC12477294

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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.