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Completed

NCT Number: NCT06168227

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

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

Disitamb Vedotin

Drug

RC48-ADC based therapy

Other names: RC48

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 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.

  2. Objective Response Rate (ORR)

    Time frame: 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 outcomes

  1. The Number of Participants Who Experienced Adverse Events (AE)

    Time frame: 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).

  2. Overall Survival (OS)

    Time frame: 2 years

    It is defined as the time from the start of treatment to death for any reason.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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