A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Recruiting · NCT07673029 · Interventional (participants receive a specific treatment) · Lead sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
GQ1005T-DM1
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed.
- The First Affiliated Hospital of Bengbu Medical University - Bengbu, Anhui, China
- The Affiliated Fuyang Hospital of Anhui Medical University - Fuyang, Anhui, China
- The First Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- Anhui Cancer Hospital - Hefei, Anhui, China
- The Fifth Medical Center of the Chinese People's Liberation Army General Hospital - Beijing, Beijing Municipality, China
- Chongqing University Cancer Hospital - Chongqing, Chongqing Municipality, China
- Fujian Cancer Hospital - Fuzhou, Fujian, China
- The Second Affiliated Hospital of Fujian Medical University - Quanzhou, Fujian, China
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- Meizhou People's Hospital - Meizhou, Guangdong, China
- Shantou Central Hospital - Shantou, Guangdong, China
- Guangxi Medical University Cancer Hospital - Nanning, Guangxi, China
- Guizhou Provincial People's Hospital - Guiyang, Guizhou, China
- Guizhou Medical University Cancer Hospital - Guiyang, Guizhou, China
- The Affiliated Hospital of Hebei University - Baoding, Hebei, China
- The Affiliated Hospital of Hebei University of Engineering - Handan, Hebei, China
- The Fourth Hospital of Hebei Medical University - Shijiazhuang, Hebei, China
- Xingtai People's Hospital - Xingtai, Hebei, China
- Harbin Medical University Cancer Hospital - Harbin, Heilongjiang, China
- Anyang Cancer Hospital - Anyang, Henan, China
- Luoyang Central Hospital - Luoyang, Henan, China
- The First Affiliated Hospital of Henan University of Science and Technology - Luoyang, Henan, China
- The First Affiliated Hospital of Henan Medical University - Xinxiang, Henan, China
- Xuchang Central Hospital - Xuchang, Henan, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Renmin Hospital of Wuhan University - Wuhan, Hubei, China
- Zhongnan Hospital of Wuhan University - Wuhan, Hubei, China
- Hubei Cancer Hospital - Wuhan, Hubei, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- Yongzhou Central Hospital - Yongzhou, Hunan, China
- Xuzhou Central Hospital - Xuzhou, Jiangsu, China
- Ganzhou Cancer Hospital - Ganzhou, Jiangxi, China
- Nanchang People's Hospital - Nanchang, Jiangxi, China
- The First Hospital of Jilin University - Changchun, Jilin, China
- The Second Affiliated Hospital of Dalian Medical University - Dalian, Liaoning, China
- The First Affiliated Hospital of Jinzhou Medical University - Jinzhou, Liaoning, China
- The First Affiliated Hospital of China Medical University - Shenyang, Liaoning, China
- Liaoning Cancer Hospital - Shenyang, Liaoning, China
- The Second Affiliated Hospital of Xi'an Jiaotong University - Xi'an, Shaanxi, China
- The First Affiliated Hospital of Xi'an Jiaotong University - Xi'an, Shaanxi, China
- Shandong Cancer Hospital - Jinan, Shandong, China
- The Second People's Hospital of Liaocheng City - Linqing, Shandong, China
- Linyi Cancer Hospital - Linyi, Shandong, China
- Linyi Central Hospital - Linyi, Shandong, China
- The Affiliated Hospital of Qingdao University - Qingdao, Shandong, China
- Yidu Central Hospital of Weifang City - Qingzhou, Shandong, China
- Weifang People's Hospital - Weifang, Shandong, China
- Yantai Yuhuangding Hospital - Yantai, Shandong, China
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University - Shanghai, Shanghai Municipality, China
- Shanghai Gaobo Cancer Hospital - Shanghai, Shanghai Municipality, China
- Shanxi Cancer Hospital - Taiyuan, Shanxi, China
- The Third People's Hospital of Chengdu City - Chengdu, Sichuan, China
- West China Hospital of Sichuan University - Chengdu, Sichuan, China
- Deyang People's Hospital - Deyang, Sichuan, China
- The Second People's Hospital of Neijiang City - Neijiang, Sichuan, China
Showing 60 of 70 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →