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Antibody-drug conjugate
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
Shanghai, China
Phase 2 & 3
Waitlist Available
Research Sponsored by RemeGen Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death from any cause, assessed up to 48 months
Awards & highlights
No Placebo-Only Group
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.
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Eligible Conditions
- Endocrine Breast Disease
- Breast Cancer
- Advanced Breast Cancer with Liver Metastases
- Breast Disease
- Capecitabine
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of death from any cause, assessed up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death from any cause, assessed up to 48 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival (PFS) as Assessed by an IRC
Secondary study objectives
Clinical Benefit Rate （CBR）
Duration of Objective Response (DOR)
Objective Response Rate （ORR）
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RC48-ADCExperimental Treatment1 Intervention
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.
Group II: Lapatinib + CapecitabineActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RC48-ADC
2019
Completed Phase 2
~340
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Who is running the clinical trial?
RemeGen Co., Ltd.Lead Sponsor
83 Previous Clinical Trials
10,836 Total Patients Enrolled