Menu
Not yet recruiting NCT07129187

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

Phase II Interventional Early Breast Cancer HER2 + Breast Cancer Stage II Breast Cancer Stage III Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-A1811.
Who it may be relevant to
Registry conditions: Early Breast Cancer, HER2 + Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response

Overview

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.

Detailed description

Patients will receive SHR-A1811, until completion or treatment discontinuation due to progression, toxicity, or withdrawal. The primary endpoint is tpCR (ypT0/is ypN0). Secondary endpoints include bpCR, RCB, EFS, and safety. The study will recruit 30 eligible patients from multiple centers in China.

Interventions

  • Drug SHR-A1811
    Drug: SHR-A1811 4.8mg/kg

Primary outcome measures

  • tpCR [Time frame: immediately after surgery]
Secondary outcome measures (3)
  • Breast Pathological Complete Response [Time frame: immediately after surgery]
  • event free survival [Time frame: until the end of the study]
  • residual cancer burden [Time frame: immediately after surgery]

Eligibility criteria

Inclusion criteria

  • 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;
  • 2.Early or locally advanced HER2-positive invasive breast cancer;
  • 3.Known hormone receptor status;
  • 4.ECOG score of 0-1;
  • 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;
  • 6.Organ function levels must meet the following requirements:
  • 7.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.
  • 8.The subjects voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

  • 1\. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer
  • 2\. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention
  • 3\. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history
  • 4\. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)
  • 5\. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)
  • 6\. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases
  • 7\. History of or planned administration of live attenuated vaccines within 28 days
  • 8\. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis
  • 9\. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year
  • 10\. History of allogeneic bone marrow or solid organ transplantation
  • 11\. Peripheral neuropathy of grade ≥ 2
  • 12\. Severe heart diseases
  • 13\. Receipt of systemic immunostimulant therapy within 4 weeks
  • 14\. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)
  • 15\. Allergy to study drugs/excipients, or history of severe allergic reaction to other monoclonal antibodies
  • 16\. Pregnant or lactating women; fertile women with positive pregnancy test or unwilling to take effective contraception throughout the trial
  • 17\. History of neurological/psychiatric disorders , or history of substance abuse, alcoholism, or drug addiction
  • 18\. Other circumstances deemed unsuitable for enrollment by the researcher

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07129187 · MA-BC-II-124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗