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

24 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

228

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: GQ1005
GQ1005 will be administered intravenously every 21 days.
Droga: GQ1005
Administered I.V.
Sperimentale: T-DM1
T-DM1 will be administered intravenously every 21 days.
Droga: T-DM1
Amministrato I.V.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Lasso di tempo: Up to approximately 24 months
Up to approximately 24 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sopravvivenza globale (SO)
Lasso di tempo: Fino a circa 24 mesi
Fino a circa 24 mesi
Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1
Lasso di tempo: Up to approximately 24 months
Up to approximately 24 months
Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1
Lasso di tempo: Up to approximately 24 months
Up to approximately 24 months
Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1
Lasso di tempo: Up to approximately 24 months
Up to approximately 24 months
Disease Control Rate (DCR) by BICR and investigator assessment per RECIST 1.1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GeneQuantum Healthcare (Suzhou) Co., Ltd.

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 gennaio 2025

Completamento primario (Stimato)

9 gennaio 2027

Completamento dello studio (Stimato)

9 gennaio 2028

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

29 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • GQ1005-301

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro al seno HER2-positivo

Prove cliniche su T-DM1

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Malaysia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
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