Status:

COMPLETED

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

Lead Sponsor:

The First Affiliated Hospital with Nanjing Medical University

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-85 years

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 c...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

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

Key Trial Info

Start Date :

October 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 30 2023

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06168227

Start Date

October 1 2021

End Date

September 30 2023

Last Update

December 13 2023

Active Locations (1)

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Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China, 210000

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