Actively Recruiting
A Phase II Study of SHR-A1811 Alone or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Led by Shengjing Hospital · Updated on 2024-07-05
65
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Shengjing Hospital
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of SHR-A1811 alone or combined with pyrotinib maleate as a neoadjuvant treatment for female patients with Stage II-III HER2-positive breast cancer. This phase II trial involves patients who have not previously received treatment and aims to assess how well these therapies work before surgery. The study is sponsored by Shengjing Hospital and focuses on improving treatment outcomes for this specific breast cancer type. Participants will receive six cycles of either SHR-A1811 monotherapy or SHR-A1811 combined with pyrotinib maleate. After completing the neoadjuvant therapy, patients will undergo surgery within four weeks. Efficacy assessments will be conducted every two cycles during the treatment period to monitor responses. During the trial, researchers will evaluate the total pathological complete response at the time of surgery, along with other measures such as breast pathological complete response, residual cancer burden, and overall response rate during the 18 weeks of neoadjuvant treatment. Long-term outcomes including overall survival, disease-free survival, and event-free survival will be followed for five years. Participants' health-related quality of life will also be monitored throughout the treatment period.
CONDITIONS
Brief Title
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Histologically confirmed HER2-positive invasive breast cancer
- Treatment-naive patients with Stage II-III breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Good organ function
You will not qualify if you...
- Previously received any anti-tumor therapy including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy
- Receiving any other anti-tumor therapy simultaneously
- Having bilateral breast cancer, inflammatory breast cancer, or occult breast cancer
- Diagnosed with Stage IV breast cancer
- History of any malignancies in the past 5 years except cured cervical carcinoma in situ and melanoma skin cancer
- Inability to swallow or conditions affecting drug absorption, such as chronic diarrhea or intestinal obstruction
- Participation in other drug clinical trials within 4 weeks before enrollment
- Known allergies to study drug components
- Clinically significant pulmonary diseases
- Clinically significant cardiovascular diseases
- History of immunodeficiency
- Active hepatitis or liver cirrhosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 weeks
Participants receive SHR-A1811 alone or combined with Pyrotinib as neoadjuvant treatment for HER2-positive breast cancer.
Multiple visits during treatment
Duration - Up to 5 years
Participants are monitored for overall survival, disease-free survival, event-free survival, and health-related quality of life after treatment.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
Research Team
N
Nan Niu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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