A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
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
1 other identifier
interventional
228
1 country
70
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2025
Typical duration for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2025
CompletedFirst Submitted
Initial submission to the registry
June 17, 2026
CompletedFirst Posted
Study publicly available on registry
June 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 9, 2028
June 29, 2026
June 1, 2026
2 years
June 17, 2026
June 24, 2026
Conditions
Outcome Measures
Primary Outcomes (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)
Up to approximately 24 months
Secondary Outcomes (11)
Overall Survival (OS)
Up to approximately 24 months
Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1
Up to approximately 24 months
Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1
Up to approximately 24 months
Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1
Up to approximately 24 months
Disease Control Rate (DCR) by BICR and investigator assessment per RECIST 1.1
Up to approximately 24 months
- +6 more secondary outcomes
Study Arms (2)
GQ1005
EXPERIMENTALGQ1005 will be administered intravenously every 21 days.
T-DM1
EXPERIMENTALT-DM1 will be administered intravenously every 21 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004, China
The Affiliated Fuyang Hospital of Anhui Medical University
Fuyang, Anhui, 236000, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001, China
Anhui Cancer Hospital
Hefei, Anhui, 230031, China
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Meizhou People's Hospital
Meizhou, Guangdong, 514011, China
Shantou Central Hospital
Shantou, Guangdong, 515031, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Guizhou Medical University Cancer Hospital
Guiyang, Guizhou, 550004, China
The Affiliated Hospital of Hebei University
Baoding, Hebei, 71000, China
The Affiliated Hospital of Hebei University of Engineering
Handan, Hebei, 56002, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50011, China
Xingtai People's Hospital
Xingtai, Hebei, 54001, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Anyang Cancer Hospital
Anyang, Henan, 455000, China
Luoyang Central Hospital
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453003, China
Xuchang Central Hospital
Xuchang, Henan, 461000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Yongzhou Central Hospital
Yongzhou, Hunan, 425000, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, 341000, China
Nanchang People's Hospital
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121001, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Second People's Hospital of Liaocheng City
Linqing, Shandong, 252601, China
Linyi Cancer Hospital
Linyi, Shandong, 276001, China
Linyi Central Hospital
Linyi, Shandong, 276003, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Yidu Central Hospital of Weifang City
Qingzhou, Shandong, 262500, China
Weifang People's Hospital
Weifang, Shandong, 261041, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
Shanghai Gaobo Cancer Hospital
Shanghai, Shanghai Municipality, 201103, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 30013, China
The Third People's Hospital of Chengdu City
Chengdu, Sichuan, 610031, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Deyang People's Hospital
Deyang, Sichuan, 618000, China
The Second People's Hospital of Neijiang City
Neijiang, Sichuan, 641003, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
The First People's Hospital of Hangzhou City
Hangzhou, Zhejiang, 310006, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First People's Hospital of Xiaoshan District, Hangzhou City
Hangzhou, Zhejiang, 311200, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040, China
Study Officials
- PRINCIPAL INVESTIGATOR
Zefei Jiang, M.D.
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2026
First Posted
June 29, 2026
Study Start
January 10, 2025
Primary Completion (Estimated)
January 9, 2027
Study Completion (Estimated)
January 9, 2028
Last Updated
June 29, 2026
Record last verified: 2026-06