Trials / Completed
CompletedNCT06168227
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 85 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Disitamb Vedotin | RC48-ADC based therapy |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2023-06-30
- Completion
- 2023-09-30
- First posted
- 2023-12-13
- Last updated
- 2023-12-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06168227. Inclusion in this directory is not an endorsement.