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The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally advanced HR-negative or low expression, HER2 low expression breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 plus Adebrelimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 | Drug | SHR-A1811 |
| |
| Adebrelimab |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed tpCR | Approximately 18 weeks after the first dose (after breast cancer surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Approximately 18 weeks after the first dose (before breast cancer surgery) | |
| Change in Ki-67 index | Approximately 18 weeks after the first dose (after breast cancer surgery) |
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Inclusion Criteria:
Female treatment-naïve patients aged ≥18 years and ≤75 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Breast cancer meeting the following criteria:
Adequate major organ function.
Females of childbearing potential must agree to use highly effective contraception methods and avoid egg donation, and must have a negative serum pregnancy test within 7 days prior to the first treatment and during the study period. They must not be breastfeeding.
Voluntarily agrees to participate in the clinical study and signs the informed consent form.
Exclusion Criteria:
Tumor-related medical history and treatment history:
Any of the following comorbidities/ medical history or treatment history:
Known or suspected interstitial pneumonia; moderate to severe pulmonary disease significantly affecting respiratory function within three months before the first dose that could interfere with the detection or management of drug-related pulmonary toxicity; any pulmonary involvement from autoimmune, connective tissue, or inflammatory diseases, or previous total lung resection.
Severe cardiovascular disease.
Investigator determines any of the following:
Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS), active tuberculosis, active hepatitis B, hepatitis C, or concurrent hepatitis B and C infections.
Vascular thrombotic event within 3 months before randomization, such as deep vein thrombosis or pulmonary embolism.
Severe infection within 4 weeks before randomization, or fever > 38.5°C of unknown cause during screening or before the first dose.
Clinically significant bleeding symptoms or a known tendency to bleed within 1 month before signing the informed consent; known genetic or acquired bleeding or thrombotic tendencies.
Abnormal coagulation function, bleeding tendency, or ongoing anticoagulant therapy with thrombolytics or long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy.
Other conditions that make the patient unsuitable for the study, such as severe systemic disease, kidney transplant, active bleeding disorders, or serious chronic gastrointestinal diseases related to diarrhea.
Meets any of the following criteria related to study treatment:
Participation in other anticancer therapy clinical trials concurrently.
Received live attenuated vaccines within 30 days before the first dose of the study intervention.
Previous or planned allogeneic bone marrow transplantation or solid organ transplantation.
Women who have given birth within 1 year or are currently breastfeeding.
Known history of substance abuse, alcoholism, or drug addiction.
Other serious physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study or interfere with the study results, as determined by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanyuan Wei | Contact | +0518-81220121 | yuanyuan.wei.yw11@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| Drug |
Adebrelimab |
|
| Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) | From signing the informed consent form to 40 days after the last dose of SHR-A1811, or 90 days after the last dose of Adebrelimab Injection (whichever is later) |