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

Breast Cancer Clinical Trial

Official title:

A Multicenter and Real-world Analysis of Clinical Outcomes and Safety of the Novel Recombinant Humanized Anti-HER2 Therapeutic Antibody RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06168227
• Other study ID #: 20230905RC48
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Disitamb Vedotin
RC48-ADC based therapy

Locations

Country	Name	City	State
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	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.	2 years
Primary	Objective Response Rate (ORR)	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	2 years
Secondary	The Number of Participants Who Experienced Adverse Events (AE)	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).	2 years
Secondary	Overall Survival (OS)	It is defined as the time from the start of treatment to death for any reason.	2 years