A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
- Conditions
- Interventions
- Registration Number
- NCT03500380
- Lead Sponsor
- RemeGen Co., Ltd.
- Brief Summary
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 301
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description RC48-ADC RC48-ADC Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination. Lapatinib + Capecitabine Lapatinib Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m\^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Lapatinib + Capecitabine Capecitabine Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m\^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) as Assessed by an IRC From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months Tumor response was assessed by an IRC according to RECIST v1.1.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) as Assessed by Investigator From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months Tumor response was assessed by investigator according to RECIST v1.1.
Objective Response Rate （ORR） From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Duration of Objective Response (DOR) From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier.
Clinical Benefit Rate （CBR） From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments \>/=4 weeks apart.
Time to Treatment Failure From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause.
Overall Survival From date of randomization until the date of death from any cause, assessed up to 48 months OS was defined as the time from the date of randomization to the date of death from any cause.
Trial Locations
- Locations (67)
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Peking University People's Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
Bin Zhou No.1 People's Hospital
🇨🇳Binzhou, China
Jilin Cancer Hospital
🇨🇳Changchun, China
The First Hospital of Jilin University
🇨🇳Changchun, China
Hunan Cancer Hospital
🇨🇳Changsha, China
The Second Xiyang Hospital of Central South University
🇨🇳Changsha, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
West China Hospital,Sichuan University
🇨🇳Chengdu, China
Chongqing University Three gorges Hospital
🇨🇳Chongqing, China
The Southwest Hospital of AMU
🇨🇳Chongqing, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Sun Yat-Sen Memorial Hospital
🇨🇳Guangzhou, China
The Affiliated Tumor Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Medical School of Zhejiang University
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Guizhou Cancer Hospital
🇨🇳Guiyang, China
Anhui Cancer Hospital
🇨🇳Hefei, China
Anhui Province Hospital
🇨🇳Hefei, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
The First People's Hospital of Jining
🇨🇳Jining, China
The Affiliated Tumor Hospital of Guangxi Medical University
🇨🇳Nanning, China
Hospital of Qingdao University
🇨🇳Qingdao, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, China
Yue Bei People's Hospital
🇨🇳Shaoguan, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Tai'an City Central Hospital
🇨🇳Tai'an, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, China
Tianjin Cancer Hospitial
🇨🇳Tianjin, China
Hubei Cancer Hospital
🇨🇳Wuhan, China
Wuhan Union Hospital
🇨🇳Wuhan, China
Xing Tai People's Hospital
🇨🇳Xingtai, China
Xuzhou Central Hospital
🇨🇳Xuzhou, China
Yanbian University Hospital
🇨🇳Yanbian, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Yuncheng Central Hospital
🇨🇳Yuncheng, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
An Yang Cancer Hospital
🇨🇳Anyang, China
Beijing Luhe Hospital
🇨🇳Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The First Hospital Jilin University
🇨🇳Changchun, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Ha'erbin, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
Linyi Cancer Hospital
🇨🇳Linyi, China
Yunnan Cancer Hospital
🇨🇳Kunming, China
The First Affiliated Hospital of Henan University of Science & Technology
🇨🇳Luoyang, China
The Second People's Hospital of Neijiang
🇨🇳Neijiang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, China
Shanghai Changhai Hospital
🇨🇳Shanghai, China
The First Affiliated Hospital of the Fourth Military University of P.L.A.
🇨🇳Xi'an, China
Taizhou Enze Medical Center
🇨🇳Taizhou, China
Weihai Municipal Hospital
🇨🇳Weihai, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, China
Tongji Medical College of HUST
🇨🇳Wuhan, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China
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