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

The First Affiliated Hospital with Nanjing Medical University150 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Breast Cancer

Interventions

Disitamb VedotinDRUG

RC48-ADC based therapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 2 years

Secondary Outcomes

The Number of Participants Who Experienced Adverse Events (AE)

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).

Time frame: 2 years

Overall Survival (OS)

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

Time frame: 2 years

Data from ClinicalTrials.gov

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