NCT07679360RecruitingPhase 3
A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- 2 Sept 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07679360
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 2 Sept 2026 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Participants with known or suspected interstitial pneumonia.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital of Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.