Clinical trial · Observational
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
NCT06168227CI-TRIAL-00072195completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the efficacy and safety of Disitamb Vedotin in patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Disitamb Vedotin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational Group
- description
- Patients receive RC48
- interventionNames
- Drug: Disitamb Vedotin
Primary outcomes (2)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 2 years
- description
- 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.
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.