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A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

24. juni 2026 opdateret af: GeneQuantum Healthcare (Suzhou) Co., Ltd.

A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane

This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a phase III, multicenter, open-label, randomized controlled study comparing GQ1005 with Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane. Approximately 228 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive GQ1005 or T-DM1, respectively.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

228

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Anhui
      • Bengbu, Anhui, Kina, 233004
        • Rekruttering
        • The First Affiliated Hospital of Bengbu Medical University
        • Kontakt:
          • Zhang Mingliang
      • Fuyang, Anhui, Kina, 236000
        • Rekruttering
        • The Affiliated Fuyang Hospital of Anhui Medical University
        • Kontakt:
          • Yingying Du
      • Hefei, Anhui, Kina, 230031
        • Rekruttering
        • Anhui Cancer Hospital
        • Kontakt:
          • Yueyin Pan
      • Hefei, Anhui, Kina, 230001
        • Rekruttering
        • The First Affiliated Hospital of Anhui Medical University
        • Kontakt:
          • Xinghua Han
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100071
        • Rekruttering
        • The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
        • Kontakt:
          • Zefei Jiang
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400030
        • Rekruttering
        • Chongqing University Cancer Hospital
        • Kontakt:
          • Xianjun Tang
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Rekruttering
        • Fujian Cancer Hospital
        • Kontakt:
          • Fan Wu
      • Quanzhou, Fujian, Kina, 362000
        • Rekruttering
        • The Second Affiliated Hospital of Fujian Medical University
        • Kontakt:
          • Jianqing Lin
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Rekruttering
        • Sun Yat-sen University Cancer Center
        • Kontakt:
          • Fei Xu
      • Guangzhou, Guangdong, Kina, 510120
        • Rekruttering
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Kontakt:
          • Ying Wang
        • Ledende efterforsker:
          • Jianli Zhao
      • Meizhou, Guangdong, Kina, 514011
        • Rekruttering
        • Meizhou People's Hospital
        • Kontakt:
          • Jingna Wu
      • Shantou, Guangdong, Kina, 515031
        • Rekruttering
        • Shantou Central Hospital
        • Kontakt:
          • Zhiyong Wu
    • Guangxi
      • Nanning, Guangxi, Kina, 530021
        • Rekruttering
        • Guangxi Medical University Cancer Hospital
        • Kontakt:
          • Weimin Xie
    • Guizhou
      • Guiyang, Guizhou, Kina, 550002
        • Rekruttering
        • Guizhou Provincial People's Hospital
        • Kontakt:
          • Yong Li
      • Guiyang, Guizhou, Kina, 550004
        • Rekruttering
        • Guizhou Medical University Cancer Hospital
        • Kontakt:
          • Zhihong Wang
    • Hebei
      • Baoding, Hebei, Kina, 71000
        • Rekruttering
        • The Affiliated Hospital of Hebei University
        • Kontakt:
          • Hua Yang
      • Handan, Hebei, Kina, 56002
        • Rekruttering
        • The Affiliated Hospital of Hebei University of Engineering
        • Kontakt:
          • Jianjun Han
      • Shijiazhuang, Hebei, Kina, 50011
        • Rekruttering
        • The Fourth Hospital of Hebei Medical University
        • Kontakt:
          • Yunjiang Liu
      • Xingtai, Hebei, Kina, 54001
        • Rekruttering
        • Xingtai People's Hospital
        • Kontakt:
          • Li Wang
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • Rekruttering
        • Harbin Medical University Cancer Hospital
        • Kontakt:
          • Qingyuan Zhang
    • Henan
      • Anyang, Henan, Kina, 455000
        • Rekruttering
        • Anyang Cancer Hospital
        • Kontakt:
          • Jing Sun
      • Luoyang, Henan, Kina, 471003
        • Rekruttering
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Kontakt:
          • Xinshuai Wang
      • Luoyang, Henan, Kina, 471000
        • Rekruttering
        • Luoyang Central Hospital
        • Kontakt:
          • Mingli Ni
      • Xinxiang, Henan, Kina, 453003
        • Rekruttering
        • The First Affiliated Hospital of Henan Medical University
        • Kontakt:
          • Yinghua Ji
      • Xuchang, Henan, Kina, 461000
        • Rekruttering
        • Xuchang Central Hospital
        • Kontakt:
          • Ping Li
      • Zhengzhou, Henan, Kina, 450008
        • Rekruttering
        • Henan Cancer Hospital
        • Kontakt:
          • Min Yan
      • Zhengzhou, Henan, Kina, 450052
        • Rekruttering
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
          • Fang Wang
    • Hubei
      • Wuhan, Hubei, Kina, 430071
        • Rekruttering
        • Zhongnan Hospital of Wuhan University
        • Kontakt:
          • Haijun Yu
      • Wuhan, Hubei, Kina, 430030
        • Rekruttering
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
          • Huihua Xiong
      • Wuhan, Hubei, Kina, 430060
        • Rekruttering
        • Renmin Hospital of Wuhan University
        • Kontakt:
          • Feng Yao
      • Wuhan, Hubei, Kina, 430079
        • Rekruttering
        • Hubei Cancer Hospital
        • Kontakt:
          • Xinhong Wu
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
          • Yanxia Zhao
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Rekruttering
        • Hunan Cancer Hospital
        • Kontakt:
          • Quchang Ouyang
      • Yongzhou, Hunan, Kina, 425000
        • Rekruttering
        • Yongzhou Central Hospital
        • Kontakt:
          • Sijuan Du
    • Jiangsu
      • Xuzhou, Jiangsu, Kina, 221009
        • Rekruttering
        • Xuzhou Central Hospital
        • Kontakt:
          • Yanhua Liu
    • Jiangxi
      • Ganzhou, Jiangxi, Kina, 341000
        • Rekruttering
        • Ganzhou Cancer Hospital
        • Kontakt:
          • Yongqiang Ye
      • Nanchang, Jiangxi, Kina, 330006
        • Rekruttering
        • Nanchang People's Hospital
        • Kontakt:
          • Yili Wang
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • Rekruttering
        • The First Hospital of JiLin University
        • Kontakt:
          • Jiuwei Cui
    • Liaoning
      • Dalian, Liaoning, Kina, 116023
        • Rekruttering
        • The Second Affiliated Hospital of Dalian Medical University
        • Kontakt:
          • Man Li
      • Jinzhou, Liaoning, Kina, 121001
        • Rekruttering
        • The First Affiliated Hospital Of Jinzhou Medical University
        • Kontakt:
          • Zhenhua Zhai
      • Shenyang, Liaoning, Kina, 110001
        • Rekruttering
        • The First Affiliated Hospital of China Medical University
        • Kontakt:
          • Yuee Teng
      • Shenyang, Liaoning, Kina, 110042
        • Rekruttering
        • Liaoning Cancer Hospital
        • Kontakt:
          • Tao Sun
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • Rekruttering
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Kontakt:
          • Jin Yang
      • Xi'an, Shaanxi, Kina, 710004
        • Rekruttering
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Kontakt:
          • Shuqun Zhang
    • Shandong
      • Jinan, Shandong, Kina, 250117
        • Rekruttering
        • Shandong Cancer Hospital
        • Kontakt:
          • ZhiyongYu
      • Linqing, Shandong, Kina, 252601
        • Rekruttering
        • The Second People's Hospital of Liaocheng City
        • Kontakt:
          • Yanjun Wang
      • Linyi, Shandong, Kina, 276001
        • Rekruttering
        • Linyi Cancer Hospital
        • Kontakt:
          • Jingfen Wang
      • Linyi, Shandong, Kina, 276003
        • Rekruttering
        • Linyi Central Hospital
        • Kontakt:
          • Yuzhou Li
      • Qingdao, Shandong, Kina, 266003
        • Rekruttering
        • The Affiliated Hospital of Qingdao University
        • Kontakt:
          • WenfengLi
      • Qingzhou, Shandong, Kina, 262500
        • Rekruttering
        • Yidu Central Hospital of Weifang City
        • Kontakt:
          • Peng Wang
      • Weifang, Shandong, Kina, 261041
        • Rekruttering
        • Weifang People's Hospital
        • Kontakt:
          • Wenhui Wang
      • Yantai, Shandong, Kina, 264000
        • Rekruttering
        • Yantai Yuhuangding Hospital
        • Kontakt:
          • Ping Sun
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Rekruttering
        • Fudan University Shanghai Cancer Center
        • Kontakt:
          • Biyun Wang
      • Shanghai, Shanghai Municipality, Kina, 200127
        • Rekruttering
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Kontakt:
          • Jinsong Lu
      • Shanghai, Shanghai Municipality, Kina, 201103
        • Rekruttering
        • Shanghai Gaobo Cancer Hospital
        • Kontakt:
          • Shuang Li
    • Shanxi
      • Taiyuan, Shanxi, Kina, 30013
        • Rekruttering
        • Shanxi Cancer Hospital
        • Kontakt:
          • Guohui Han
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Rekruttering
        • West China Hospital of Sichuan University
        • Kontakt:
          • Ting Luo
      • Chengdu, Sichuan, Kina, 610031
        • Rekruttering
        • The Third People's Hospital of Chengdu City
        • Kontakt:
          • Zhume Luo
      • Deyang, Sichuan, Kina, 618000
        • Rekruttering
        • Deyang People's Hospital
        • Kontakt:
          • Xinjian Jia
      • Neijiang, Sichuan, Kina, 641003
        • Rekruttering
        • The Second People's Hospital of Neijiang City
        • Kontakt:
          • Xujuan Wang
      • Suining, Sichuan, Kina, 629000
        • Rekruttering
        • Suining Central Hospital
        • Kontakt:
          • Hongwei Yang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300060
        • Rekruttering
        • Tianjin Cancer Hospital
        • Kontakt:
          • Yehui Shi
    • Yunnan
      • Kunming, Yunnan, Kina, 650118
        • Rekruttering
        • Yunnan Cancer Hospital
        • Kontakt:
          • Wenlin Chen
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Rekruttering
        • Zhejiang Cancer Hospital
        • Kontakt:
          • Yabing Zheng
      • Hangzhou, Zhejiang, Kina, 310009
        • Rekruttering
        • The Second Affiliated hospital of Zhejiang University school of medicine
        • Kontakt:
          • Fuming Qiu
      • Hangzhou, Zhejiang, Kina, 310016
        • Rekruttering
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Xian Wang
      • Hangzhou, Zhejiang, Kina, 310006
        • Rekruttering
        • The First People's Hospital of Hangzhou City
        • Kontakt:
          • Jian Liu
      • Hangzhou, Zhejiang, Kina, 310006
        • Rekruttering
        • Women's Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Jingpei Long
      • Hangzhou, Zhejiang, Kina, 311200
        • Rekruttering
        • The First People's Hospital of Xiaoshan District, Hangzhou City
        • Kontakt:
          • Zhenyu Wang
      • Ningbo, Zhejiang, Kina, 315040
        • Rekruttering
        • The Affiliated People's Hospital of Ningbo University
        • Kontakt:
          • Zhengyang Xu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
  • Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
  • Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
  • Presence of at least one measurable lesion according to RECIST v1.1
  • Expected survival time ≥ 12 weeks.
  • Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion Criteria:

  • Prior anti-HER2 ADC therapy.
  • Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy.
  • Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.
  • Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer
  • Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult
  • Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GQ1005
GQ1005 will be administered intravenously every 21 days.
Medicin: GQ1005
Administered I.V.
Eksperimentel: T-DM1
T-DM1 will be administered intravenously every 21 days.
Medicin: T-DM1
Administreret I.V.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Tidsramme: Up to approximately 24 months
Up to approximately 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse (OS)
Tidsramme: Op til cirka 24 måneder
Op til cirka 24 måneder
Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
Disease Control Rate (DCR) by BICR and investigator assessment per RECIST 1.1
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
Adverse events：Number and percentage of patients who report serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), TEAEs leading to study drug discontinuation, adverse events of special interest (AESIs) (graded according to the Nationa
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
PK parameters：Plasma concentrations of GQ1005 ADC, total anti-HER2 antibody and free toxin DXd at each time point
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
Anti-drug antibodies (ADA)：Number and percentage of patients who develop anti-drug antibody (ADA).
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Tidsramme: Up to approximately 24 months
Change from baseline in EQ-5D-5L health state utility index score and Visual Analogue Scale (VAS) score. VAS score range from 0-100, higher scores indicate better health status.
Up to approximately 24 months
Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30
Tidsramme: Up to approximately 24 months
Change from baseline in the functioning/symptom/global quality of life (QoL) subscales of EORTC QLQ-C30. Scale scores range from 0-100. For functioning and global QoL scales, higher scores indicate better functioning or global health status. For symptom scales, higher scores indicate greater symptom burden.
Up to approximately 24 months
Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EORTC QLQ-BR45
Tidsramme: Up to approximately 24 months
Change from baseline in the functioning/symptom subscales of EORTC QLQ-BR45. Scale scores range from 0-100. For functioning scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom burden.
Up to approximately 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GeneQuantum Healthcare (Suzhou) Co., Ltd.

Efterforskere

  • Ledende efterforsker: Zefei Jiang, M.D., The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. januar 2025

Primær færdiggørelse (Anslået)

9. januar 2027

Studieafslutning (Anslået)

9. januar 2028

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • GQ1005-301

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HER2-positiv brystkræft

Kliniske forsøg med T-DM1

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