Clinical trial · Interventional
A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer
A Multicenter, Open Phase II Clinical Study to Evaluate the Efficacy and Safety of Disitamb Vedotin Combined With Pyrotinib in Previously Untreated Histologically Proven HER2 Positive Early Breast Cancer
NCT06001086CI-TRIAL-00072412recruitingPhase 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)
Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early 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 ,pyrotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Disitamb Vedotin combined with pyrotinib
- description
- Disitamb Vedotin: 2 mg/kg，ivgtt，d1,14/28day/cycle pyrotinib:320mg, oral, every day.
- interventionNames
- Drug: Disitamb Vedotin ,pyrotinib
Primary outcomes (1)
- measure
- pathologic complete response（pCR）
- timeFrame
- 1 year
- description
- The pCR rate is defined as the proportion of subjects who, after completion of neoadjuvant therapy, showed no evidence of residual invasive lesions in H\&E staining in completely excised breast specimens and all sampled local lymph nodes (ypT0/TisypN0) through central evaluation
Secondary outcomes (4)
- measure
- Disease free survival （DFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1.18 to 75 years old (at the time of signing the informed consent form), regardless of gender. 2\. Subject type and disease characteristics. Histologically confirmed HER2 positive EBC subjects: 1. evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines. 2. Single and multifocal tumors (greater than 1 tumor area limited to the same quadrant as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as HER2 positive. 3. Multicenter tumors (multiple tumors involving more than one breast quadrant) must sample one lesion from each affected quadrant and be confirmed as HER2 positive by the central laboratory. 4. According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative). 5. Clinical staging at visit (based on breast X-ray or breast MRI evaluation): Stage II-IIIC determined by the AJCC staging system, 8th edition. (f) Lymph node involvement is determined by fine needle aspiration or coarse needle aspiration biopsy (if applicable). 3\. When randomized, ECOG physical fitness status is 0 or 1 point. Exclusion Criteria: 1. Previous history of invasive breast cancer. 2. Stage IV breast cancer according to AJCC staging system version 8. 3. Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease. 4. DCIS medical history, except for the subjects who only received Mastectomy 5. According to the judgment of the researchers, there is evidence of any diseases (such as severe or uncontrolled systemic diseases, including persistent or active infections, uncontrolled hypertension, kidney transplantation and active bleeding diseases, and severe chronic gastrointestinal diseases related to diarrhea) that the researchers consider to be unfavorable for the participants to participate in the study or may affect adherence to the protocol. 6. Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.