RecruitingPhase 2NCT05635487
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
Sponsor
Shengjing Hospital
Enrollment
65 participants
Start Date
Mar 16, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- 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 Criteria12
- 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
Interventions
DRUGSHR-A1811
SHR-A1811
DRUGPyrotinib
Pyrotinib
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05635487
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