A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative 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: Trastuzumab Rezetecan for Injection, Adebrelimab Injection, Capecitabine tablets, Pembrolizumab injection.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: 18 years — 75 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Trastuzumab Rezetecan for Injection
Trastuzumab Rezetecan for Injection. - Drug Adebrelimab Injection
Adebrelimab Injection. - Drug Capecitabine tablets
Capecitabine Tables. - Drug Pembrolizumab injection
Pembrolizumab Injection.
Primary outcome measures
- Invasive disease-free survival (iDFS) [Time frame: Until study completion, assessed up to approximately 5 years.]
Secondary outcome measures (5)
- Disease-free survival (DFS) [Time frame: Until study completion, assessed up to approximately 5 years.]
- Overall survival (OS) [Time frame: Until study completion, assessed up to approximately 5 years.]
- DRFI (Distant recurrence-free interval) [Time frame: Until study completion, assessed up to approximately 5 years.]
- Adverse events (AEs) [Time frame: Until study completion, assessed up to approximately 2 years.]
- Serious adverse events (SAEs) [Time frame: Until study completion, assessed up to approximately 3 years.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
- 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.
- History of immunodeficiency.
- Participants with known or suspected interstitial pneumonia.
- 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.
- 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 medical conditions that would interfere with study participation or follow-up.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital of Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07679360 · SHR-A1811-318