Breast CancerPhase 2NCT07466303
Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer
A Phase 2 study testing Serplulimab and SHR-A1811 in people with Breast Cancer and Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Serplulimab in combination with Trastuzumab Restuzumab for the neoadjuvant treatment of triple-negative breast cancer, aiming to provide evidence for optimizing the strategy of combining immunotherapy with ADC drugs in the neoadjuvant setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer
- What is being tested?
- Serplulimab and SHR-A1811
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 1 Apr 2031
- Phase
- Phase 2
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 70 years, inclusive.
- Histologically confirmed, treatment-naïve, early-stage triple-negative breast cancer (TNBC), defined as estrogen receptor (ER) and progesterone receptor (PR) expression <1% by immunohistochemistry (IHC), and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0/1+ or IHC 2+ with negative in situ hybridization confirmation) per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
- Clinical stage T1cN1-2 or T2-4N0-2 according to the American Joint Committee on Cancer (AJCC) staging system, 8th edition.
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, renal, and cardiac function within 14 days prior to enrollment:
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- Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L (without transfusion or growth factor support within 14 days).
- Hepatic: Total bilirubin ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
- Renal: Serum creatinine and blood urea nitrogen (BUN) ≤1.5 × ULN.
- Cardiac: Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiogram; corrected QT interval (QTc) <470 ms on 12-lead electrocardiogram (ECG).
- Willingness to provide archival or fresh tumor tissue sample for programmed death-ligand 1 (PD-L1) biomarker analysis using the 22C3 pharmDx assay.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Evidence of metastatic (Stage IV) disease or bilateral breast cancer at diagnosis.
- Prior systemic anticancer therapy (including chemotherapy, endocrine therapy, immunotherapy, or biological therapy) for any malignancy within 4 weeks before the first dose of study treatment.
- Diagnosis of any other malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, basal cell carcinoma, or carcinoma in situ of the cervix.
- Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV-DNA ≥500 IU/mL), or hepatitis C virus (detectable HCV-RNA).
- Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic antibiotic therapy within 2 weeks, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
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- History of allogeneic hematopoietic stem cell or solid organ transplantation.
- Pregnant or lactating women, or women of childbearing potential who are unwilling to use a highly effective method of contraception during the treatment period and for at least 7 months after the last dose.
- Known hypersensitivity to any component of serplulimab or SHR-A1811.
- Any condition that, in the opinion of the investigator, would compromise patient safety or interfere with the completion of the study procedures.
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
the First Affiliated Hospital of the Air Force Medical University
Xi'an, 710032
Ju Liang J L Zhang, MD, 029-84775271, vascularzhang@163.com
About this study
Official title: Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer: A Phase II Single-Arm Clinical Study
To evaluate the efficacy and safety of Serplulimab in combination with Trastuzumab Restuzumab for the neoadjuvant treatment of triple-negative breast cancer, aiming to provide evidence for optimizing the strategy of combining immunotherapy with ADC drugs in the neoadjuvant setting.
Read the detailed description
This is a prospective, single-arm, open-label, Phase II clinical trial investigating the efficacy and safety of a non-chemotherapy regimen comprising Serplulimab (an anti-PD-1 monoclonal antibody) and Trastuzumab Restuzumab (SHR-A1811, an antibody-drug conjugate) as neoadjuvant therapy for early-stage triple-negative breast cancer.
Primary Objective:To assess the pathological complete response rate, defined as the absence of invasive carcinoma in both the breast and sampled regional lymph nodes (ypT0/Tis ypN0), following neoadjuvant treatment with serplulimab plus SHR-A1811.
Secondary Objectives:
To evaluate invasive disease-free survival, event-free survival, and the objective response rate according to RECIST 1.1 criteria.
To determine the rate of breast-conserving surgery. To characterize the safety and tolerability profile of the combination regimen, including the incidence and severity of adverse events.
Study Design:
This study employs a Simon's two-stage, single-arm design. Approximately 84 treatment-naïve female patients with early-stage TNBC (clinical stage T1cN1-2 or T2-4N0-2) will be enrolled. Participants will receive six cycles of serplulimab and SHR-A1811 prior to definitive surgery. The primary endpoint will be centrally assessed on the surgical pathology specimen.
Interventions:
Serplulimab: Administered intravenously at a protocol-specified dose every three weeks for six cycles.
SHR-A1811: Administered intravenously at a protocol-specified dose every three weeks for six cycles.
Statistical Methods:
The study is designed to test the hypothesis that the combination regimen will increase the pCR rate from a historical benchmark of 30% to 40%. With a one-sided alpha level of 0.05 and 80% statistical power, a minimum of 75 evaluable patients is required. Allowing for an estimated 10% dropout rate, a total of 84 patients will be enrolled. The primary efficacy analysis of the pCR rate will be conducted on the full analysis set using an exact binomial test. The 95% confidence interval for the pCR rate will be calculated via the Clopper-Pearson exact method. Time-to-event endpoints will be analyzed using the Kaplan-Meier method.
- Conditions
- Breast Cancer, Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer
- Being tested
- Serplulimab, SHR-A1811
- Keywords
- Neoadjuvant Therapy, Pathological Complete Response, Serplulimab, PD-1 Inhibitor, Antibody-Drug Conjugate, Trastuzumab Deruxtecan, Phase II Clinical Trial, Triple-Negative Breast Cancer, HER2-Low Breast Cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Administered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting.
SHR-A1811Drug
Administered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Serplulimab + SHR-A1811 | Experimental | All enrolled participants will receive the investigational combination therapy as neoadjuvant treatment. This regimen consists of Serplulimab (an anti-PD-1 monoclonal antibody) and SHR-A1811 (Trastuzumab Restuzumab , an antibody-drug conjugate). Both agents are administered intravenously every 3 weeks (Q3W) for 6 cycles prior to definitive surgery. The primary objective is to evaluate the efficacy and safety of this chemotherapy-free combination in patients with early-stage triple-negative breast cancer (TNBC). Receives: Drug: Serplulimab; Drug: SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Proportion of participants achieving a pathological complete response, defined as the absence of residual invasive cancer in the breast and sampled ipsilateral lymph nodes (ypT0/Tis, ypN0) upon pathological review of the surgical resection specimen following completion of neoadjuvant therapy.
Measured: At the time of definitive surgery (after 6 cycles of neoadjuvant therapy; each cycle is 21 days).
Secondary outcomes (5)
Objective Response Rate (ORR)
Proportion of participants achieving a best overall response of complete response or partial response, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 during the neoadjuvant treatment phase.
Measured: From baseline until the end of neoadjuvant therapy (up to 6 cycles), with tumor assessments performed at the end of Cycles 2, 4, and 6（each cycle is 21days).
Invasive Disease-Free Survival (iDFS)
Time from the date of definitive surgery to the date of the first occurrence of invasive ipsilateral breast tumor recurrence, invasive loco-regional recurrence, distant recurrence, or death from any cause.
Measured: From surgery until first documented iDFS event or death, assessed up to 5 years (60 months).
Event-Free Survival (EFS)
Time from the date of enrollment to the date of the first occurrence of any of the following: disease progression that precludes planned surgery, invasive local/regional or distant recurrence following surgery, or death from any cause.
Measured: From enrollment until first documented EFS event or death, assessed up to 5 years (60 months).
Breast-Conserving Surgery Rate
Proportion of participants who undergo successful breast-conserving surgery as the definitive surgical procedure following neoadjuvant therapy.
Measured: During surgery
Incidence and Severity of Adverse Events
Frequency, severity (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0), and investigator-assessed relationship to study treatment of all adverse events and serious adverse events.
Measured: From first study treatment administration until 30 days after the last dose (approximately 25 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start25 Mar 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466303
- Sponsor's protocol ID
- KY20252486-F-1
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer: A Phase II Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07466303
- Acronym / sponsor ID
- KY20252486-F-1
- Conditions
- Breast Cancer, Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer
- Keywords
- Neoadjuvant Therapy, Pathological Complete Response, Serplulimab, PD-1 Inhibitor, Antibody-Drug Conjugate, Trastuzumab Deruxtecan, Phase II Clinical Trial, Triple-Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 12 Mar 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.
To evaluate the efficacy and safety of Serplulimab in combination with Trastuzumab Restuzumab for the neoadjuvant treatment of triple-negative breast cancer, aiming to provide evidence for optimizing the strategy of combining immunotherapy with ADC drugs in the neoadjuvant setting.
Detailed description
This is a prospective, single-arm, open-label, Phase II clinical trial investigating the efficacy and safety of a non-chemotherapy regimen comprising Serplulimab (an anti-PD-1 monoclonal antibody) and Trastuzumab Restuzumab (SHR-A1811, an antibody-drug conjugate) as neoadjuvant therapy for early-stage triple-negative breast cancer.
Primary Objective:To assess the pathological complete response rate, defined as the absence of invasive carcinoma in both the breast and sampled regional lymph nodes (ypT0/Tis ypN0), following neoadjuvant treatment with serplulimab plus SHR-A1811.
Secondary Objectives:
To evaluate invasive disease-free survival, event-free survival, and the objective response rate according to RECIST 1.1 criteria.
To determine the rate of breast-conserving surgery. To characterize the safety and tolerability profile of the combination regimen, including the incidence and severity of adverse events.
Study Design:
This study employs a Simon's two-stage, single-arm design. Approximately 84 treatment-naïve female patients with early-stage TNBC (clinical stage T1cN1-2 or T2-4N0-2) will be enrolled. Participants will receive six cycles of serplulimab and SHR-A1811 prior to definitive surgery. The primary endpoint will be centrally assessed on the surgical pathology specimen.
Interventions:
Serplulimab: Administered intravenously at a protocol-specified dose every three weeks for six cycles.
SHR-A1811: Administered intravenously at a protocol-specified dose every three weeks for six cycles.
Statistical Methods:
The study is designed to test the hypothesis that the combination regimen will increase the pCR rate from a historical benchmark of 30% to 40%. With a one-sided alpha level of 0.05 and 80% statistical power, a minimum of 75 evaluable patients is required. Allowing for an estimated 10% dropout rate, a total of 84 patients will be enrolled. The primary efficacy analysis of the pCR rate will be conducted on the full analysis set using an exact binomial test. The 95% confidence interval for the pCR rate will be calculated via the Clopper-Pearson exact method. Time-to-event endpoints will be analyzed using the Kaplan-Meier method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Serplulimab + SHR-A1811 | Experimental | Drug: Serplulimab, Drug: SHR-A1811All enrolled participants will receive the investigational combination therapy as neoadjuvant treatment. This regimen consists of Serplulimab (an anti-PD-1 monoclonal antibody) and SHR-A1811 (Trastuzumab Restuzumab , an antibody-drug conjugate). Both agents are administered intravenously every 3 weeks (Q3W) for 6 cycles prior to definitive surgery. The primary objective is to evaluate the efficacy and safety of this chemotherapy-free combination in patients with early-stage triple-negative breast cancer (TNBC). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female patients aged 18 to 70 years, inclusive.
- Histologically confirmed, treatment-naïve, early-stage triple-negative breast cancer (TNBC), defined as estrogen receptor (ER) and progesterone receptor (PR) expression <1% by immunohistochemistry (IHC), and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0/1+ or IHC 2+ with negative in situ hybridization confirmation) per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
- Clinical stage T1cN1-2 or T2-4N0-2 according to the American Joint Committee on Cancer (AJCC) staging system, 8th edition.
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Evidence of metastatic (Stage IV) disease or bilateral breast cancer at diagnosis.
- Prior systemic anticancer therapy (including chemotherapy, endocrine therapy, immunotherapy, or biological therapy) for any malignancy within 4 weeks before the first dose of study treatment.
- Diagnosis of any other malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, basal cell carcinoma, or carcinoma in situ of the cervix.
- Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV-DNA ≥500 IU/mL), or hepatitis C virus (detectable HCV-RNA).
- Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.
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 |
|---|---|---|
| SerplulimabAdministered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting. | Drug | Neoadjuvant Serplulimab + SHR-A1811 |
| SHR-A1811Administered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting. | Drug | Neoadjuvant Serplulimab + SHR-A1811 |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At the time of definitive surgery (after 6 cycles of neoadjuvant therapy; each cycle is 21 days).
Proportion of participants achieving a pathological complete response, defined as the absence of residual invasive cancer in the breast and sampled ipsilateral lymph nodes (ypT0/Tis, ypN0) upon pathological review of the surgical resection specimen following completion of neoadjuvant therapy.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: From baseline until the end of neoadjuvant therapy (up to 6 cycles), with tumor assessments performed at the end of Cycles 2, 4, and 6（each cycle is 21days).
Invasive Disease-Free Survival (iDFS)
Time frame: From surgery until first documented iDFS event or death, assessed up to 5 years (60 months).
Event-Free Survival (EFS)
Time frame: From enrollment until first documented EFS event or death, assessed up to 5 years (60 months).
Breast-Conserving Surgery Rate
Time frame: During surgery
Incidence and Severity of Adverse Events
Time frame: From first study treatment administration until 30 days after the last dose (approximately 25 weeks).
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 12 Mar 2026.
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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 2 study testing Serplulimab and SHR-A1811 in people with Breast Cancer and Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer, run by Xijing Hospital 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 12 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ju Liang Zhang, Prof (029-84775271, vascularzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At the time of definitive surgery (after 6 cycles of neoadjuvant therapy; each cycle is 21 days).). 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 12 Mar 2026.