A Study of Trastuzumab Rezetecan in Combination With Adeb... | NCT07679360

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

NCT07679360

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

1,000Estimated

Phase

Phase 3

Conditions

Triple Negative Breast Cancer

Interventions

Trastuzumab Rezetecan for Injection
Adebrelimab Injection
Capecitabine tablets
Pembrolizumab injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2032Estimated

First Submitted Date

Jun 25, 2026

First Submission Date that Met QC Criteria

Jun 25, 2026

First Posted Date

Jul 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab Rezetecan for Injection	Drug	Trastuzumab Rezetecan for Injection.	Trastuzumab Rezetecan combined with Adebrelimab Group

Measure	Description	Time Frame
Invasive disease-free survival (iDFS)		Until study completion, assessed up to approximately 5 years.

Measure	Description	Time Frame
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.

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D007267	Injections
D000069287	Capecitabine
C582435	pembrolizumab

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides