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

Launched by SHENGJING HOSPITAL · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with HER2-positive breast cancer, which is a specific type of breast cancer that can grow more aggressively. The trial will look at how effective and safe a medication called SHR-A1811 is when given alone or combined with another drug, pyrotinib maleate, before surgery. Participants will receive this treatment for about six cycles, followed by surgery to remove the cancer. Throughout the trial, doctors will check how well the treatment is working.

To participate in this study, women need to be between 18 and 75 years old, and they must have a confirmed diagnosis of stage II or III HER2-positive breast cancer that has not been treated before. They should also be in relatively good health, with no serious medical issues. It’s important for potential participants to know that they shouldn’t have received any other cancer treatments prior to this trial. If you or someone you know meets these criteria, this trial could provide an opportunity to access new treatments while contributing to important research.

Gender

FEMALE

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