A Multicenter and Real-world Analysis of RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Disitamb Vedotin

• Registration Number: NCT06168227
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

Evaluate the efficacy and safety of Disitamb Vedotin in patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer

Detailed Description

The main goal of this clinical trial is to examinie the utilization of RC48 in different HER2 statuses, elucidating its clinical outcomes and safety, and investigating the factors that influence its clinical efficacy. The primary endpoint was the objective response rate (ORR) assessed by the primary researcher. Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), time to progression, and safety.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. histopathologically or imaging-confirmedlocally advanced or metastatic breast cancer ;
2. HER2-positive or low status;
3. the function of major organswas normal, no treatmentcontraindications , andthe estimated survival time was more than 2 months;
4. at least one extracranialmeasurable lesion or osteolytic or mixed bone metastases inaccordance with the Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1);
5. the clinical data were complete and traceable.

Exclusion Criteria

1. age <18 ye ars old;
2. other concurrent cancers;
3. patients who rece ived RC48 as a neoadjuvant or adjuvant regimen；
4. Incomplete medical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Group	Disitamb Vedotin	Patients receive RC48

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	2 years	Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Objective Response Rate (ORR)	2 years	The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	2 years	It is defined as the time from the start of treatment to death for any reason.
The Number of Participants Who Experienced Adverse Events (AE)	2 years	Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

Trial Locations

Locations (1)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China