SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response

NCT07129187 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-BC-II-124
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.

Conditions

Early Breast Cancer; HER2 + Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Keywords

neoadjuvant therapy; antibody drug conjugate; SHR-A1811; suboptimal response

Outcome Measures

Primary Outcomes (1)

• tpCR

  It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.

  immediately after surgery

Secondary Outcomes (3)

• Breast Pathological Complete Response

  immediately after surgery

• event free survival

  until the end of the study

• residual cancer burden

  immediately after surgery

Study Arms (1)

SHR-A1811

EXPERIMENTAL

Drug: SHR-A1811

Interventions

SHR-A1811 DRUG

Drug: SHR-A1811 4.8mg/kg

SHR-A1811

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with newly diagnosed breast cancer aged 18 to 70 years old;
• Early or locally advanced HER2-positive invasive breast cancer;
• Known hormone receptor status;
• ECOG score of 0-1;
• Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;
• Organ function levels must meet the following requirements:
• Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.
• The subjects voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• \. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer
• \. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention
• \. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history
• \. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)
• \. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)
• \. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases
• \. History of or planned administration of live attenuated vaccines within 28 days
• \. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis
• \. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year
• \. History of allogeneic bone marrow or solid organ transplantation
• \. Peripheral neuropathy of grade ≥ 2
• \. Severe heart diseases
• \. Receipt of systemic immunostimulant therapy within 4 weeks
• \. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)
• \. Allergy to study drugs/excipients, or history of severe allergic reaction to other monoclonal antibodies

Sponsors & Collaborators

• Chuan Wang: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 26, 2025

Record last verified: 2025-08