A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
- Conditions
- Breast NeoplasmsBreast DiseasesCapecitabineHER2-positive Breast CancerHER2 Positive Breast CarcinomaHER2-positive Advanced Breast With Liver Metastases
- 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 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. 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.
- 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.
Related Research Topics
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Trial Locations
- Locations (67)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
An Yang Cancer Hospital
🇨🇳Anyang, China
Beijing Luhe Hospital
🇨🇳Beijing, 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 Jilin University
🇨🇳Changchun, China
Scroll for more (57 remaining)Cancer Hospital Chinese Academy of Medical Sciences🇨🇳Beijing, Beijing, China