A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811, Pyrotinib.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Overview
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.
Interventions
- Drug SHR-A1811
SHR-A1811 - Drug Pyrotinib
Pyrotinib
Primary outcome measures
- Total pathological complete response (tpCR: ypT0-is/ypN0) [Time frame: At the time of surgery]
Secondary outcome measures (8)
- Breast pathological complete response (bpCR：ypT0-is) [Time frame: At the time of surgery]
- Residual cancer burden (RCB) [Time frame: At the time of surgery]
- Best overall response rate (BORR) [Time frame: During 18 weeks of the neoadjuvant treatment]
- Overall survival (OS) [Time frame: 5 years]
- Disease-free survival (DFS) [Time frame: 5 years]
- Event-free survival (EFS) [Time frame: 5 years]
- Health-related quality of life (HRQOL) (EORTC QLQ-C30) [Time frame: During 18 weeks of the neoadjuvant treatment]
- Health-related quality of life (HRQOL) [Time frame: During 18 weeks of the neoadjuvant treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shengjing Hospital affiliated to China Medical University — Shenyang
Identifiers
NCT: NCT05635487 · MUKDEN 07