NCT05911958 A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
| NCT ID | NCT05911958 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henan Cancer Hospital |
| Condition | HER2 Low Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-07-05 |
| Primary Completion | 2024-12-31 |
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 66 participants in total. It began in 2023-07-05 with a primary completion date of 2024-12-31.
⚠ 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
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 70 years old (inclusive); 2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0; 3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology; 4. ECOG performance status of 0-1; 5. Normal organ and bone marrow function; 6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding; 7. Patients voluntarily joined the study and signed informed consent; Exclusion Criteria: 1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer; 2. Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma; 3. Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy; 4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures; 5. Clinically significant pulmonary or cardiovascular disease; 6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption; 7. Known to be allergic to any study drug or any of its excipients; 8. History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 9. Pregnant and lactating women; 10. Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.
Contact & Investigator
Zhenzhen Liu, PhD
PRINCIPAL INVESTIGATOR
Henan Cancer Hospital
Frequently Asked Questions
Who can join the NCT05911958 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying HER2 Low Breast Carcinoma. 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 NCT05911958 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 NCT05911958 currently recruiting?
Yes, NCT05911958 is actively recruiting participants. Contact the research team at liuzhenzhen73@126.com for enrollment information.
Where is the NCT05911958 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT05911958 clinical trial?
NCT05911958 is sponsored by Henan Cancer Hospital. The principal investigator is Zhenzhen Liu, PhD at Henan Cancer Hospital. The trial plans to enroll 66 participants.