Trastuzumab rezetecan with adebrelimab for triple negative breast cancer with leftover cancer after treatment
Compares trastuzumab rezetecan plus adebrelimab with usual drugs in triple negative breast cancer.
Plain-language title generated from the registry record
Registry title: A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07679360, who can take part
Where in China
- Cancer Hospital of Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Trial code
- NCT07679360
- Record updated
- 9 September 2026
- Original description
It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.Read full original descriptionShow less
A Phase III, Multicenter, Randomized, Open-Label Parallel-Controlled Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With Adebrelimab (SHR-1316) Versus Investigator's Choice of Therapy in Subjects With Primary Triple Negative Breast Cancer Who Have Residual Invasive Disease Following Neoadjuvant Therapy
It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.
Inclusion: Pathologically confirmed invasive triple negative breast cancer; Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy; Previous neoadjuvant therapy must meet the requirements of the protocol; Has received radical surgery for breast cancer; ECOG PS 0~1; Adequate organ functions; Women of childbearing potential must be willing to use highly effective form of contraception.
Exclusion: Previously received antibody coupled drug (ADC) therapy with topoisomerase inhibitors as effective payloads; Previously received HER2 targeted therapy; Active or previously recorded autoimmune or inflammatory diseases; Within the 6 months prior to randomization, there was a history of myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, ≥ Grade 2 supraventricular or ventricular arrhythmias, and any grade of ventricular fibrillation; Known allergy to any investigational drug or its excipients; Stage IV metastatic breast cancer; Previous invasive breast cancer or ductal carcinoma in situ; Bilateral breast cancer; Any clinical evidence indicating the exist of recurrent diseases after surgery; History of other malignancy within the last 5 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ; History of immunodeficiency; Presence of active Hepatitis B; Known to have active tuberculosis infection; Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs for treatment; Other medical conditions that would interfere with study participation or follow-up; Participants with known or suspected interstitial pneumonia.