A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Study Overview
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Brief Summary
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This is a single-arm, phase II trial evaluating the efficacy and safety of SHR-A1811 combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 and pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Official Title
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A Single-arm, Phase II Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Conditions
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HER2-positive Breast Cancer

Intervention / Treatment
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* Drug: SHR-A1811
* Drug: Pyrotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-A1811+Pyrotinib<br> | Drug: SHR-A1811<br>* SHR-A1811<br>Drug: Pyrotinib<br>* Pyrotinib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total pathological complete response (tpCR: ypT0-is/ypN0) |  | At the time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast pathological complete response (bpCR：ypT0-is) |  | At the time of surgery | 
| Residual cancer burden (RCB) |  | At the time of surgery | 
| Best overall response rate (BORR) |  | During 18 weeks of the neoadjuvant treatment | 
| Overall survival (OS) |  | 5 years | 
| Disease-free survival (DFS) |  | 5 years | 
| Event-free survival (EFS) |  | 5 years | 
| Health-related quality of life (HRQOL) (EORTC QLQ-C30) | The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30) | During 18 weeks of the neoadjuvant treatment | 
| Health-related quality of life (HRQOL) | The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL. | During 18 weeks of the neoadjuvant treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR-A1811, Pyrotinib, HER2-positive Breast Cancer, Neoadjuvant