NCT05635487 A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
| NCT ID | NCT05635487 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shengjing Hospital |
| Condition | HER2-positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2023-03-16 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 65 participants in total. It began in 2023-03-16 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Caigang Liu, MD
PRINCIPAL INVESTIGATOR
Shengjing Hospital
Frequently Asked Questions
Who can join the NCT05635487 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05635487 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05635487 currently recruiting?
Yes, NCT05635487 is actively recruiting participants. Contact the research team at niunannancy@163.com for enrollment information.
Where is the NCT05635487 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT05635487 clinical trial?
NCT05635487 is sponsored by Shengjing Hospital. The principal investigator is Caigang Liu, MD at Shengjing Hospital. The trial plans to enroll 65 participants.
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