A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer
NCT07679360
Phase
Phase 3
Recruitment status
Not yet recruiting
Participants
1,000
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Start date
2026-07-01
Number of sites
- Summary
- 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.
- Short title
- A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2032-12-01
- First posted
- 2026-07-01
- Registry last updated
- 2026-07-01
- Primary completion date
- 2030-12-01
- Start date
- 2026-07-01
- Participants
- 1,000
- Participant count basis
- Estimated
- Planned participants
- 1,000
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07679360
- ClinicalTrials.gov ID
- NCT07679360
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Invasive disease-free survival (iDFS)
Timeframe: Until study completion, assessed up to approximately 5 years.
Disease-free survival (DFS)
Timeframe: Until study completion, assessed up to approximately 5 years.
Overall survival (OS)
Timeframe: Until study completion, assessed up to approximately 5 years.
DRFI (Distant recurrence-free interval)
Timeframe: Until study completion, assessed up to approximately 5 years.
Adverse events (AEs)
Timeframe: Until study completion, assessed up to approximately 2 years.
Serious adverse events (SAEs)
Timeframe: Until study completion, assessed up to approximately 3 years.
Sources for outcomes
- Sex
- Female
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
Sources for eligibility
- Cancer Hospital of Chinese Academy of Medical SciencesBeijing, China
Sources for sites
Related records
Drugs (4)
Lead sponsors (1)
Conditions (1)
- Triple-negative breast carcinoma Primary condition