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

Nanjing Medical University

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Disitamb Vedotin

Study type: Observational

Funder types: Other

Identifiers

NCT06168227

20230905RC48

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Observational Group

Description:

Patients receive RC48

Treatment:

Drug: Disitamb Vedotin