Clinical trial · Interventional
RC48-ADC in HER2-low Advanced Breast Cancer
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
NCT05831878CI-TRIAL-00111426recruitingN/AClinicalTrials.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)
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
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 |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Disitamab vedotin | Drug | Disitamab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RC48-ADC
- description
- RC48-ADC as salvage treatment for HER2-low advanced breast cancer
- interventionNames
- Drug: Disitamab vedotin
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)
- description
- The percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people.Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥18 years * Expected survival ≥12 weeks * ECOG 0-1 * Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable * At least one measurable lesion according to the RECIST 1.1 * No history of antibody-drug conjugate use * Up to one previous chemotherapy for advanced disease * Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease * HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \>0 but ≤10% of tumor cells * Adequate organ function Exclusion Criteria: * History of thromboembolic events * Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc. * Active infections requiring systemic treatment * Pregnant or lactating * Presence of brain metastases and/or carcinomatous meningitis
References
Publications (0)
Data not yet available
No reference posted for this study.