Triple Negative Breast CancerPhase 3NCT07679360
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 3 study testing Trastuzumab Rezetecan for Injection, Adebrelimab Injection and Capecitabine tablets in people with Triple Negative Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Trastuzumab Rezetecan for Injection, Adebrelimab Injection and Capecitabine tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2026to Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Binghe Xu, +86-010-67781331, xubinghe@medmail.com.cn
Binghe Xu
About this study
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
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
- Being tested
- Trastuzumab Rezetecan for Injection, Adebrelimab Injection, Capecitabine tablets, Pembrolizumab injection
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezetecan for InjectionDrug
Trastuzumab Rezetecan for Injection.
Adebrelimab InjectionDrug
Adebrelimab Injection.
Capecitabine tabletsDrug
Capecitabine Tables.
Pembrolizumab injectionDrug
Pembrolizumab Injection.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Rezetecan combined with Adebrelimab Group | Experimental | Trastuzumab Rezetecan combined with Adebrelimab. Receives: Drug: Trastuzumab Rezetecan for Injection; Drug: Adebrelimab Injection |
| Capecitabine and Pembrolizumab | Active comparator | Capecitabine or Pembrolizumab or Capecitabine combined with Pembrolizumab. Receives: Drug: Capecitabine tablets; Drug: Pembrolizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease-free survival (iDFS)
Measured: Until study completion, assessed up to approximately 5 years.
Secondary outcomes (5)
Disease-free survival (DFS)
Measured: Until study completion, assessed up to approximately 5 years.
Overall survival (OS)
Measured: Until study completion, assessed up to approximately 5 years.
DRFI (Distant recurrence-free interval)
Measured: Until study completion, assessed up to approximately 5 years.
Adverse events (AEs)
Measured: Until study completion, assessed up to approximately 2 years.
Serious adverse events (SAEs)
Measured: Until study completion, assessed up to approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start2 Sep 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open label.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679360
- Sponsor's protocol ID
- SHR-A1811-318
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07679360
- Acronym / sponsor ID
- SHR-A1811-318
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open label.
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab Rezetecan combined with Adebrelimab Group | Experimental | Drug: Trastuzumab Rezetecan for Injection, Drug: Adebrelimab InjectionTrastuzumab Rezetecan combined with Adebrelimab. |
| Capecitabine and Pembrolizumab | Active comparator | Drug: Capecitabine tablets, Drug: Pembrolizumab injectionCapecitabine or Pembrolizumab or Capecitabine combined with Pembrolizumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab Rezetecan for InjectionTrastuzumab Rezetecan for Injection. | Drug | Trastuzumab Rezetecan combined with Adebrelimab Group |
| Adebrelimab InjectionAdebrelimab Injection. | Drug | Trastuzumab Rezetecan combined with Adebrelimab Group |
| Capecitabine tabletsCapecitabine Tables. | Drug | Capecitabine and Pembrolizumab |
| Pembrolizumab injectionPembrolizumab Injection. | Drug | Capecitabine and Pembrolizumab |
Primary outcome
Invasive disease-free survival (iDFS)
Time frame: Until study completion, assessed up to approximately 5 years.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Triple Negative Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab Rezetecan for Injection, Adebrelimab Injection and Capecitabine tablets in people with Triple Negative Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiye Chen, M.M (+86-0518-82342973, zhiye.chen.zc78@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (iDFS) (time frame: Until study completion, assessed up to approximately 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.