Clinical trial · Interventional
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
- 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 phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib | ALIAS |
| SHR-A1811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-A1811+Pyrotinib
- interventionNames
- Drug: SHR-A1811
- Drug: Pyrotinib
- type
- EXPERIMENTAL
- label
- SHR-A1811
- interventionNames
- Drug: SHR-A1811
Primary outcomes (1)
- measure
- Total pathological complete response (tpCR: ypT0-is/ypN0)
- timeFrame
- At the time of surgery
Secondary outcomes (8)
- measure
- Breast pathological complete response (bpCR：ypT0-is)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥ 18 but ≤ 75 years * Histologically confirmed to be HER2-positive invasive breast cancer * Treatment-naive patients with stage II-III * Eastern Cooperative Oncology Group (ECOG) score 0-1 * Good level of organ function Exclusion Criteria: * Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) * Received any other anti-tumor therapy at the same time * Bilateral breast cancer, inflammatory breast cancer or occult breast cancer * Stage IV breast cancer * With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer * Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption * Participated in other drug clinical trials within 4 weeks before enrollment * History of allergies to the drug components of this protocol * Clinically significant pulmonary diseases * Clinically significant cardiovascular diseases * History of immunodeficiency * Active hepatitis and liver cirrhosis
References
Publications (0)
Data not yet available