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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06168227

Enrollment

150

Registered

2023-12-13

Start date

2021-10-01

Completion date

2023-09-30

Last updated

2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

HER2-positive, HER2-low, ADC, RC48

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 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.

Interventions

DRUGDisitamb Vedotin

RC48-ADC based therapy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate (ORR)	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
Progression Free Survival (PFS)	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.

Secondary

Measure	Time frame	Description
The Number of Participants Who Experienced Adverse Events (AE)	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).
Overall Survival (OS)	2 years	It is defined as the time from the start of treatment to death for any reason.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026