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

NCT06168227 | Completed

• 1 other identifier: 20230905RC48
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

HER2-positive; HER2-low; ADC; RC48

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• The Number of Participants Who Experienced Adverse Events (AE)

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

Observational Group

Patients receive RC48

Drug: Disitamb Vedotin

Interventions

Disitamb Vedotin DRUG

RC48-ADC based therapy

Also known as: RC48

Observational Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer were eligible and received RC48 2.5 mg/kg every two weeks alone or combined with drugs with different anti-tumor mechanisms, such as immune checkpoint inhibitors (ICIs), tyrosine kinase inhibitors (TKIs) and antiangiogenic compounds.

You may qualify if:

• histopathologically or imaging-confirmedlocally advanced or metastatic breast cancer ;
• HER2-positive or low status;
• the function of major organswas normal, no treatmentcontraindications , andthe estimated survival time was more than 2 months;
• 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);
• the clinical data were complete and traceable.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: October 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)