A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer

NCT07679360 | Not Yet Recruiting Phase 3

• 1 other identifier: SHR-A1811-318
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Invasive disease-free survival (iDFS)

  Until study completion, assessed up to approximately 5 years.

Secondary Outcomes (5)

• Disease-free survival (DFS)

  Until study completion, assessed up to approximately 5 years.

• Overall survival (OS)

  Until study completion, assessed up to approximately 5 years.

• DRFI (Distant recurrence-free interval)

  Until study completion, assessed up to approximately 5 years.

• Adverse events (AEs)

  Until study completion, assessed up to approximately 2 years.

• Serious adverse events (SAEs)

  Until study completion, assessed up to approximately 3 years.

Study Arms (2)

Trastuzumab Rezetecan combined with Adebrelimab Group

EXPERIMENTAL

Trastuzumab Rezetecan combined with Adebrelimab.

Drug: Trastuzumab Rezetecan for Injection; Drug: Adebrelimab Injection

Capecitabine and Pembrolizumab

ACTIVE COMPARATOR

Capecitabine or Pembrolizumab or Capecitabine combined with Pembrolizumab.

Drug: Capecitabine tablets; Drug: Pembrolizumab injection

Interventions

Trastuzumab Rezetecan for Injection DRUG

Trastuzumab Rezetecan for Injection.

Trastuzumab Rezetecan combined with Adebrelimab Group

Adebrelimab Injection DRUG

Adebrelimab Injection.

Trastuzumab Rezetecan combined with Adebrelimab Group

Capecitabine tablets DRUG

Capecitabine Tables.

Capecitabine and Pembrolizumab

Pembrolizumab injection DRUG

Pembrolizumab Injection.

Capecitabine and Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Injections; Capecitabine; pembrolizumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Zhiye Chen, M.M

CONTACT

+86-0518-82342973; zhiye.chen.zc78@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open label.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (1)