Clinical trial · Interventional
RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer
Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent (RC48-ADC) for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression (Seraph)
NCT05134519CI-TRIAL-00055247unknownPhase 2ClinicalTrials.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)
This is a single-arm exploratory study to explore the effect of RC48 in HER2-positive neoadjuvant therapy and evaluate the non-inferiority of RC48 by comparing the latest reported data of T-DM1 in neoadjuvant therapy.
Conditions
Conditions (2)
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 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RC48 for neadjuvant chemotherapy
- description
- RC48-ADC: 2.0 mg/kg, IV drip, Q2W
- interventionNames
- Drug: Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)
Primary outcomes (1)
- measure
- Pathological complete response rate (pCR)
- timeFrame
- At the end of Cycle 1 (each cycle is 14 days)
- description
- absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0).
Secondary outcomes (1)
- measure
- adverse effects
- timeFrame
- during the period of neadjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Enrolled were ≥ 18 years of age and \< 80 years of age 2. Female or male breast cancer 3. Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test. 4. Left ventricular score ≥ 55% 5. ECOGPS score 0 or 1 6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures 7. Adequate organ function Exclusion Criteria: 1. cardiac, hepatic, renal, or psychiatric disease history 2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
References
Publications (0)
Data not yet available
No reference posted for this study.