AzTrials
AzTrials

HER2-positive Breast CancerPhase 3NCT07673029

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

A Phase 3 study testing GQ1005 and T-DM1 in people with HER2-positive Breast Cancer, run by GeneQuantum Healthcare (Suzhou) Co., Ltd. at 70 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
GQ1005 and T-DM1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
70 sitesChina
Study dates
10 Jan 2025to 9 Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

70 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenxing Yang contact

+86 13801896162

yangzx@genequantum.com

70 sites in 1 country

China70 sites, 70 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan, 455000

    Jing Sun

    Recruiting

  • The Affiliated Hospital of Hebei University

    Baoding, Hebei, 71000

    Hua Yang

    Recruiting

  • The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, 100071

    Zefei Jiang

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233004

    Zhang Mingliang

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Jiuwei Cui

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Quchang Ouyang

    Recruiting

  • The Third People's Hospital of Chengdu City

    Chengdu, Sichuan, 610031

    Zhume Luo

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Ting Luo

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Xianjun Tang

    Recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

    Man Li

    Recruiting

  • Deyang People's Hospital

    Deyang, Sichuan, 618000

    Xinjian Jia

    Recruiting

  • The Affiliated Fuyang Hospital of Anhui Medical University

    Fuyang, Anhui, 236000

    Yingying Du

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Fan Wu

    Recruiting

  • Ganzhou Cancer Hospital

    Ganzhou, Jiangxi, 341000

    Yongqiang Ye

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Fei Xu

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

    Ying Wang

    Jianli Zhao

    Recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

    Yong Li

    Recruiting

  • Guizhou Medical University Cancer Hospital

    Guiyang, Guizhou, 550004

    Zhihong Wang

    Recruiting

  • The Affiliated Hospital of Hebei University of Engineering

    Handan, Hebei, 56002

    Jianjun Han

    Recruiting

  • The First People's Hospital of Hangzhou City

    Hangzhou, Zhejiang, 310006

    Jian Liu

    Recruiting

  • Women's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006

    Jingpei Long

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Fuming Qiu

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Xian Wang

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Yabing Zheng

    Recruiting

  • The First People's Hospital of Xiaoshan District, Hangzhou City

    Hangzhou, Zhejiang, 311200

    Zhenyu Wang

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230001

    Xinghua Han

    Recruiting

  • Anhui Cancer Hospital

    Hefei, Anhui, 230031

    Yueyin Pan

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    ZhiyongYu

    Recruiting

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121001

    Zhenhua Zhai

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Wenlin Chen

    Recruiting

  • The Second People's Hospital of Liaocheng City

    Linqing, Shandong, 252601

    Yanjun Wang

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

    Jingfen Wang

    Recruiting

  • Linyi Central Hospital

    Linyi, Shandong, 276003

    Yuzhou Li

    Recruiting

  • Luoyang Central Hospital

    Luoyang, Henan, 471000

    Mingli Ni

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    Xinshuai Wang

    Recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514011

    Jingna Wu

    Recruiting

  • Nanchang People's Hospital

    Nanchang, Jiangxi, 330006

    Yili Wang

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

    Weimin Xie

    Recruiting

  • The Second People's Hospital of Neijiang City

    Neijiang, Sichuan, 641003

    Xujuan Wang

    Recruiting

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang, 315040

    Zhengyang Xu

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

    WenfengLi

    Recruiting

  • Yidu Central Hospital of Weifang City

    Qingzhou, Shandong, 262500

    Peng Wang

    Recruiting

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

    Jianqing Lin

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Biyun Wang

    Recruiting

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127

    Jinsong Lu

    Recruiting

  • Shanghai Gaobo Cancer Hospital

    Shanghai, Shanghai Municipality, 201103

    Shuang Li

    Recruiting

  • Shantou Central Hospital

    Shantou, Guangdong, 515031

    Zhiyong Wu

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Yuee Teng

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

    Tao Sun

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50011

    Yunjiang Liu

    Recruiting

  • Suining Central Hospital

    Suining, Sichuan, 629000

    Hongwei Yang

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 30013

    Guohui Han

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Yehui Shi

    Recruiting

  • Weifang People's Hospital

    Weifang, Shandong, 261041

    Wenhui Wang

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Yanxia Zhao

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Huihua Xiong

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Feng Yao

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Haijun Yu

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Xinhong Wu

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

    Shuqun Zhang

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Jin Yang

    Recruiting

  • Xingtai People's Hospital

    Xingtai, Hebei, 54001

    Li Wang

    Recruiting

  • The First Affiliated Hospital of Henan Medical University

    Xinxiang, Henan, 453003

    Yinghua Ji

    Recruiting

  • Xuchang Central Hospital

    Xuchang, Henan, 461000

    Ping Li

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

    Yanhua Liu

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

    Ping Sun

    Recruiting

  • Yongzhou Central Hospital

    Yongzhou, Hunan, 425000

    Sijuan Du

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Min Yan

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Fang Wang

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.

Being tested
GQ1005, T-DM1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GQ1005Drug

    Administered I.V.

  • T-DM1Drug

    Administered I.V.

Study groups in NCT07673029
Study groupRoleWhat they receive
GQ1005ExperimentalGQ1005 will be administered intravenously every 21 days.
Receives: Drug: GQ1005
T-DM1ExperimentalT-DM1 will be administered intravenously every 21 days.
Receives: Drug: T-DM1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Measured: Up to approximately 24 months

Secondary outcomes (11)

  1. Overall Survival (OS)

    Measured: Up to approximately 24 months

  2. Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1

    Measured: Up to approximately 24 months

  3. Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1

    Measured: Up to approximately 24 months

  4. Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1

    Measured: Up to approximately 24 months

  5. Disease Control Rate (DCR) by BICR and investigator assessment per RECIST 1.1

    Measured: Up to approximately 24 months

  6. 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

    Measured: Up to approximately 24 months

  7. PK parameters：Plasma concentrations of GQ1005 ADC, total anti-HER2 antibody and free toxin DXd at each time point

    Measured: Up to approximately 24 months

  8. Anti-drug antibodies (ADA)：Number and percentage of patients who develop anti-drug antibody (ADA).

    Measured: Up to approximately 24 months

  9. Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EQ-5D-5L

    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.

    Measured: Up to approximately 24 months

  10. 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

    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.

    Measured: Up to approximately 24 months

  11. Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EORTC QLQ-BR45

    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.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study start10 Jan 2025
  3. Primary completion9 Jan 2027 (estimated)
  4. Study completion9 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07673029
Sponsor's protocol ID
GQ1005-301
Status last verified
Jun 2026
First submitted
17 Jun 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GQ1005 and T-DM1 in people with HER2-positive Breast Cancer, run by GeneQuantum Healthcare (Suzhou) Co., Ltd. at 70 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhenxing Yang (+86 13801896162, yangzx@genequantum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07673029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in