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

Last updated: December 5, 2023
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Disitamb Vedotin

Clinical Study ID

NCT06168227
20230905RC48
  • Ages 18-85
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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 , andtheestimated survival time was more than 2 months;
  4. at least one extracranialmeasurable lesion or osteolytic or mixed bone metastasesinaccordance with the Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1);
  5. the clinical data were complete and traceable.

Exclusion

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

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Disitamb Vedotin
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
September 30, 2023

Study 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.

Connect with a study center

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu 210000
    China

    Site Not Available

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