To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
NCT ID:
NCT05635487
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
SHR-A1811
Pyrotinib
HER2-positive Breast Cancer
Neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
SHR-A1811
Arm group label:
SHR-A1811
Arm group label:
SHR-A1811+Pyrotinib
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Pyrotinib
Arm group label:
SHR-A1811+Pyrotinib
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shengjing Hospital affiliated to China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Contact:
Last name:
Nan Niu, MD
Investigator:
Last name:
Cai-Gang Liu, MD
Email:
Principal Investigator
Start date:
March 16, 2023
Completion date:
February 28, 2030
Lead sponsor:
Agency:
Shengjing Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635487
