Neoadjuvant treatment for HR-positive, low HER2 breast cancer

Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

This study is testing a new treatment called SHR-A1811 to see if it can help people with early-stage HR-positive, low HER2 breast cancer before they have surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Henan Cancer Hospital (other gov)
• Drugs / interventions: immunotherapy, Chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT05911958 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of SHR-A1811 as a neoadjuvant therapy for patients with early-stage or locally advanced HR-positive breast cancer that has low HER2 expression. Participants will receive SHR-A1811 for eight cycles before undergoing surgery, with follow-up lasting at least five years. The study aims to improve the pathological complete response rates in this specific breast cancer subtype, which currently has limited treatment options.

Who should consider this trial

Good fit: Ideal candidates are treatment-naive patients aged 18 to 70 with clinically confirmed T2-T3 HR-positive, low HER2 expression breast cancer.

Not a fit: Patients with metastatic breast cancer or those who have previously received antineoplastic therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with HR-positive, low HER2 expression breast cancer.

How similar studies have performed: Other studies have explored neoadjuvant therapies for breast cancer, but the specific use of SHR-A1811 in this context is novel.

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.

Where this trial is running

Zhengzhou, Henan

• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Principal investigator: Zhenzhen Liu, PhD — Henan Cancer Hospital
• Study coordinator: Zhenzhen Liu, Professor

Conditions: HER2 Low Breast Carcinoma