PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast CancerPhase 3NCT07111832
A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
A Phase 3 study testing SHR-A1811 for Injection, SHR-1316 Injection and Toripalimab Injection in people with PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
- What is being tested?
- SHR-A1811 for Injection, SHR-1316 Injection and Toripalimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 20 Aug 2025to Dec 2028
- 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
- Age 18-75 years old (including both ends), female.
- Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
- Expected survival ≥ 12 weeks.
- Have adequate renal and hepatic function.
- Patients voluntarily joined the study and signed the informed consent.
Who cannot join
- Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
- Have other malignancies within the past 5 years.
- Presence with uncontrollable third space effusion.
- Have undergone other anti-tumor treatment within 4 weeks before the first dose.
- A history of immunodeficiency.
- Clinically significant cardiovascular diseases.
Show all 11Show fewer
- Known or suspected interstitial lung disease.
- Known hereditary or acquired bleeding tendency.
- Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.
- Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
- Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Huiping Li, +86-010-88196380, huipingli2012@hotmail.com
Huiping Li
- Recruiting
Cancer Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, +86-021-64175590, szmgcp2-16@163.com
Zhimin Shao
About this study
Official title: A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).
- Being tested
- SHR-A1811 for Injection, SHR-1316 Injection, Toripalimab Injection, Paclitaxel for 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.
SHR-A1811 for InjectionDrug
SHR-A1811 for injection.
SHR-1316 InjectionDrug
SHR-1316 injection.
Toripalimab InjectionDrug
Toripalimab injection.
Paclitaxel for InjectionDrug
Paclitaxel for injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 and SHR-1316 Group | Experimental | Not described Receives: Drug: SHR-A1811 for Injection; Drug: SHR-1316 Injection |
| Toripalimab and Nab-paclitaxel Group | Active comparator | Not described Receives: Drug: Toripalimab Injection; Drug: Paclitaxel for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: An average of 3 year.
Secondary outcomes (6)
Overall response (OS) rate evaluated by investigators
Measured: An average of 3 year.
Clinical benefit rate (CBR) evaluated by investigators
Measured: An average of 3 year.
Duration of response (DoR) evaluated by investigators
Measured: An average of 3 year.
Progression-free survival on next-line therapy (PFS2) evaluated by investigators
Measured: An average of 3 year.
Adverse events (AEs)
Measured: An average of 3 year.
Serious adverse events (SAEs)
Measured: An average of 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start20 Aug 2025
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-L1-positive Locally Recurrent Unresectable or Metastatic 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
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT07111832
- Sponsor's protocol ID
- SHR-A1811-313
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2025
- Last updated
- 18 Dec 2025
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07111832
- Acronym / sponsor ID
- SHR-A1811-313
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Aug 2025 (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.
This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 and SHR-1316 Group | Experimental | Drug: SHR-A1811 for Injection, Drug: SHR-1316 Injection |
| Toripalimab and Nab-paclitaxel Group | Active comparator | Drug: Toripalimab Injection, Drug: Paclitaxel for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years old (including both ends), female.
- Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
- Expected survival ≥ 12 weeks.
- Have adequate renal and hepatic function.
- Patients voluntarily joined the study and signed the informed consent.
Key exclusion criteria (11 listed)
- Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
- Have other malignancies within the past 5 years.
- Presence with uncontrollable third space effusion.
- Have undergone other anti-tumor treatment within 4 weeks before the first dose.
- A history of immunodeficiency.
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 |
|---|---|---|
| SHR-A1811 for InjectionSHR-A1811 for injection. | Drug | SHR-A1811 and SHR-1316 Group |
| SHR-1316 InjectionSHR-1316 injection. | Drug | SHR-A1811 and SHR-1316 Group |
| Toripalimab InjectionToripalimab injection. | Drug | Toripalimab and Nab-paclitaxel Group |
| Paclitaxel for InjectionPaclitaxel for injection. | Drug | Toripalimab and Nab-paclitaxel Group |
Primary outcome
Progression free survival (PFS)
Time frame: An average of 3 year.
6 secondary outcomes
Overall response (OS) rate evaluated by investigators
Time frame: An average of 3 year.
Clinical benefit rate (CBR) evaluated by investigators
Time frame: An average of 3 year.
Duration of response (DoR) evaluated by investigators
Time frame: An average of 3 year.
Progression-free survival on next-line therapy (PFS2) evaluated by investigators
Time frame: An average of 3 year.
Adverse events (AEs)
Time frame: An average of 3 year.
Serious adverse events (SAEs)
Time frame: An average of 3 year.
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 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
Not yet recruiting
Clinical Study of Chemotherapy and Immunotherapy Combined With Lactobacillus Johnsonii in Patients With Multiple Irresectable Solid Tumors
Immunotherapy, Chemotherapy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A1811 for Injection, SHR-1316 Injection and Toripalimab Injection in people with PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 5 inclusion and 11 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Tingting Lei (+86-0518-82342973, tingting.lei.tl6@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: An average of 3 year.). 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 18 Dec 2025.