Neoadjuvant treatment for HER2-positive breast cancer using SHR-A1811 and pyrotinib
A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
This study is testing a new combination of two drugs, SHR-A1811 and pyrotinib, to see if they can help people with Stage II-III HER2-positive breast cancer before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy, pyrotinib |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT05635487 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the efficacy and safety of SHR-A1811, either alone or in combination with pyrotinib maleate, as a neoadjuvant treatment for patients with Stage II-III HER2-positive breast cancer. Participants will receive the treatment for six cycles before undergoing surgery within four weeks after the therapy. Efficacy will be assessed every two cycles to monitor the response to the treatment. The study aims to provide insights into the potential benefits of this combination therapy in improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 75 with histologically confirmed HER2-positive invasive breast cancer who have not received prior anti-tumor therapy.
Not a fit: Patients with stage IV breast cancer or those who have previously received any anti-tumor therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with HER2-positive breast cancer.
How similar studies have performed: Other studies have shown promise with similar neoadjuvant approaches in HER2-positive breast cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shenyang, Liaoning
- Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Caigang Liu, MD — Shengjing Hospital
- Study coordinator: Nan Niu, MD
- Email: niunannancy@163.com
- Phone: 86-18940256668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.