A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Phase 2

Active, not recruiting

• Conditions: Breast Neoplasms; Breast Diseases; Capecitabine; HER2-positive Breast Cancer; HER2 Positive Breast Carcinoma; HER2-positive Advanced Breast With Liver Metastases
• Interventions: Drug: Lapatinib; Drug: RC48-ADC; Drug: Capecitabine

• 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

Study Timeline

• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-14
• Study First Posted: 2018-04-18
• Study Start: 2018-04-24
• Status Verified: 2023-11
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

Not provided

Exclusion Criteria

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.

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

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