RC48-ADC in Breast Cancer

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Disitamab vedotin

• Registration Number: NCT05851677
• Lead Sponsor: RenJi Hospital

Brief Summary

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-04-30
• Study First Submitted QC: 2023-04-30
• Study First Posted: 2023-05-10
• Study Start: 2023-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-21
• Primary Completion: 2027-03
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Histologically confirmed breast cancer;
• Prior or current use of Disitamab vedotin (RC48-ADC);

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Exclusion Criteria

• Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RC48-ADC	Disitamab vedotin	RC48-ADC for breast cancer

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)	The time from the date of starting Disitamab Vedotin to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Adverse events	From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year)	Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, China