Clinical trial · Interventional
Trastuzumab Rezetecan Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Trastuzumab Rezetecan Plus Pertuzumab as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer:A Prospective, Open-label, Phase II Trial
NCT07047755CI-TRIAL-00091659not yet recruitingPhase 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 prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab Rezetecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Trastuzumab Rezetecan; Pertuzumab
- interventionNames
- Drug: Trastuzumab Rezetecan
- Drug: Pertuzumab
Primary outcomes (1)
- measure
- pCR rate
- timeFrame
- At the time of surgery
- description
- Total pathological complete response (tpCR: ypT0-is,ypN0)
Secondary outcomes (4)
- measure
- iDFS
- timeFrame
- Up to approximately 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged 18-70 years; 2. Histopathologically confirmed HER2 positive breast cancer; 3. Patients were diagnosed with stage II-III breast cancer; 4. At least one measurable target lesion according to RECIST V1.1; 5. ECOG performance status score of 0 to 1; 6. Life expectancy ≥12 weeks; 7. Adequate bone marrow reserve and organ system function reserve; 8. Participants should be able and willing to comply with the study protocol requirement; Exclusion Criteria: 1. Breast cancer not histologically confirmed; 2. Known inherited or acquired bleeding and thrombotic tendencies; 3. Known allergy or contraindication to the study drug and its excipients; 4. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 5. Concurrent receipt of any other form of anti-cancer therapy; 6. History of a second primary malignancy, except for adequately treated skin cancer; 7. Participation in other drug clinical trials within 4 weeks before enrollment; 8. Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures; 9. Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence; 10. Uncontrolled or significant cardiovascular and cerebrovascular diseases; 11. Subjects with known or suspected interstitial pneumonia; 12. Presence of active hepatitis B, hepatitis C, liver cirrhosis; 13. Pregnant or lactating female patients; 14. History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.