Breast CancerPhase 2NCT07528898
Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study.
A Phase 2 study testing SHR-A1811, Pertuzumab and trastuzumab in people with Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is a multicenter, two-arm, exploratory clinical study designed to evaluate the efficacy and safety of a response-guided neoadjuvant treatment strategy in patients with HER2-positive early or locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR-A1811, Pertuzumab and trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Jul 2029
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Age ≥18 and ≤70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion according to RECIST version 1.1.
- Histologically confirmed invasive breast cancer with clinical stage:
- Stage II (T2N0-1M0 or T3N0M0), or Stage III (T2N2-3M0, T3N1-3M0, or T4N0-3M0). 5.HER2-positive invasive breast cancer confirmed by histopathology, defined as: HER2 immunohistochemistry (IHC) 3+, or HER2 IHC 2+ with fluorescence in situ hybridization (FISH) positivity, as determined by the pathology department of the participating center. 6.Adequate organ function, defined as:
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- Hematologic function (no blood transfusion, blood products, granulocyte colony-stimulating factor [G-CSF], or other hematopoietic growth factors within 14 days prior to testing):
- Hemoglobin (Hb) ≥100 g/L; Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count (PLT) ≥100 × 10⁹/L.
- Biochemical function:
- Total bilirubin (TBIL) ≤1 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; Alkaline phosphatase (ALP) ≤2.5 × ULN; Blood urea nitrogen (BUN) and serum creatinine (Cr) ≤1.5 × ULN.
- Cardiac function:
- Left ventricular ejection fraction (LVEF) ≥55% by echocardiography; QT interval corrected by Fridericia's formula (QTcF) ≤450 ms. 7.Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and agree to use effective contraception during the study and for at least 8 weeks after the last dose of study treatment.
- 8.Willingness to participate in the study, provide written informed consent, and comply with study procedures and follow-up.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Prior receipt of any anti-tumor therapy not specified in the study protocol, including but not limited to chemotherapy, radiotherapy, targeted therapy, or endocrine therapy for the current breast cancer.
- Concurrent receipt of any other anti-tumor therapy during the study. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. Stage IV (metastatic) breast cancer.
- History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix.
- Severe dysfunction of major organs, including but not limited to cardiac, hepatic, or renal insufficiency.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment.
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- Known hypersensitivity to any component of the study drugs; history of immunodeficiency, including positive human immunodeficiency virus (HIV) test, active hepatitis C virus (HCV) infection, active hepatitis B infection, congenital or acquired immunodeficiency disorders, or history of organ transplantation.
- History of significant cardiac disease, including but not limited to:
- Clinically significant arrhythmia requiring treatment; Myocardial infarction; Heart failure;
- Any other cardiac condition that, in the investigator's judgment, makes the participant unsuitable for the study.
- Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at baseline or unwilling to use effective contraception throughout the study period.
- Any serious concomitant disease that, in the investigator's judgment, may compromise patient safety or interfere with study participation, including but not limited to uncontrolled hypertension, severe diabetes, or active infection.
- History of neurological or psychiatric disorders, including epilepsy or dementia.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
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 Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Li Ma, MD, 13932116886, mali1021@126.com
About this study
Official title: Exploratory Clinical Study of Neoadjuvant SHR-A1811 Combined With Pertuzumab in Patients With HER2-Positive Breast Cancer
This is a multicenter, two-arm, exploratory clinical study designed to evaluate the efficacy and safety of a response-guided neoadjuvant treatment strategy in patients with HER2-positive early or locally advanced breast cancer.
Breast cancer is the most common malignancy in women worldwide, and HER2-positive disease accounts for approximately 15-20% of cases and is associated with aggressive tumor biology and a higher risk of recurrence. The introduction of HER2-targeted therapies, including trastuzumab and pertuzumab, has significantly improved patient outcomes. However, a proportion of patients exhibit suboptimal response to standard neoadjuvant therapy, highlighting the need for more effective treatment strategies.
Read more
In this study, approximately 100 eligible patients will be enrolled. All patients will initially receive 2 cycles of standard neoadjuvant therapy with trastuzumab, pertuzumab, and chemotherapy (THP or TCbHP). Tumor response will be assessed according to RECIST version 1.1 criteria. Patients with tumor reduction greater than 40% will continue the same regimen for an additional 4 cycles. Patients with tumor reduction of 40% or less will switch to an alternative regimen consisting of SHR-A1811, a novel HER2-targeted antibody-drug conjugate, in combination with pertuzumab for 4 cycles.
SHR-A1811 is an investigational HER2-targeted antibody-drug conjugate designed to deliver a cytotoxic payload directly to tumor cells, potentially overcoming resistance to prior HER2-targeted therapies. Emerging clinical data have demonstrated promising anti-tumor activity and manageable safety in HER2-positive breast cancer.
Clinical data, including baseline characteristics, imaging findings, and pathological markers such as Ki-67, will be collected throughout the study. Efficacy will be evaluated based on imaging assessments according to RECIST 1.1 criteria and pathological response at surgery, while safety will be monitored during treatment.
The primary objective of this study is to explore whether switching to SHR-A1811 in combination with pertuzumab in patients with suboptimal early response can improve pathological complete response (pCR) rates. Secondary objectives include evaluation of safety and tolerability of the treatment strategies.
This study aims to provide evidence for an individualized, response-adapted neoadjuvant treatment approach in HER2-positive breast cancer, and to optimize treatment outcomes for patients with inadequate response to standard therapy.
Read the detailed description
HER2-positive breast cancer is driven by overexpression or amplification of the HER2 receptor, leading to activation of downstream signaling pathways such as MAPK and PI3K/AKT that promote tumor growth and survival. Although dual HER2 blockade with trastuzumab and pertuzumab in combination with chemotherapy has become a standard neoadjuvant treatment, a subset of patients exhibit insufficient tumor response, indicating biological heterogeneity and potential resistance to therapy.
Pathological complete response (pCR) after neoadjuvant treatment is associated with improved long-term outcomes in HER2-positive breast cancer. Therefore, early identification of patients with suboptimal response and timely treatment modification may represent an effective strategy to improve prognosis.
Antibody-drug conjugates (ADCs) are designed to selectively deliver cytotoxic agents to tumor cells through antigen-specific targeting. SHR-A1811 is an investigational HER2-directed ADC composed of a humanized anti-HER2 monoclonal antibody linked to a topoisomerase I inhibitor payload via a cleavable linker. Preclinical data have demonstrated potent anti-tumor activity in HER2-expressing models, including those with reduced sensitivity to prior HER2-targeted therapies.
Emerging clinical evidence supports the antitumor activity and manageable safety profile of SHR-A1811 in HER2-positive breast cancer. Its mechanism of action suggests potential benefit in patients with inadequate response to standard HER2-targeted neoadjuvant regimens.
This study is designed to investigate a response-adapted treatment strategy, in which early tumor response is used to guide subsequent therapy selection. By incorporating an alternative HER2-targeted approach for patients with suboptimal response, this study aims to explore strategies to improve treatment efficacy while maintaining an acceptable safety profile.
The results of this study are expected to provide evidence to support individualized neoadjuvant treatment strategies for patients with HER2-positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- SHR-A1811, Pertuzumab, trastuzumab, Chemotherapy
- Keywords
- HER2-positive, Neoadjuvant therapy, Antibody-drug conjugate, SHR-A1811, HER2-targeted therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811 is a HER2-targeted antibody-drug conjugate administered intravenously in combination with pertuzumab as neoadjuvant therapy.
PertuzumabDrug
Pertuzumab is a monoclonal antibody targeting HER2, administered intravenously as part of dual HER2 blockade.
trastuzumabDrug
Trastuzumab is a HER2-targeted monoclonal antibody administered intravenously as part of standard neoadjuvant therapy.
ChemotherapyDrug
Chemotherapy includes taxane-based regimens with or without carboplatin (THP or TCbHP) administered according to institutional standards.
| Study group | Role | What they receive |
|---|---|---|
| Standard Neoadjuvant Therapy (THP/TCbHP) | Active comparator | All enrolled patients will initially receive 2 cycles of standard neoadjuvant therapy with trastuzumab, pertuzumab, and chemotherapy (THP or TCbHP). Patients who achieve a tumor reduction greater than 40% according to RECIST version 1.1 will continue the same regimen for an additional 4 cycles. Receives: Drug: Pertuzumab; Drug: trastuzumab; Drug: Chemotherapy |
| SHR-A1811 Plus Pertuzumab | Experimental | All enrolled patients will initially receive 2 cycles of standard neoadjuvant therapy. Patients with a tumor reduction of 40% or less according to RECIST version 1.1 will switch to SHR-A1811 in combination with pertuzumab for 4 cycles. Receives: Drug: SHR-A1811; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pathological Complete Response (tpCR)
Number of participants achieving total pathological complete response, defined as no residual invasive cancer in both breast and axillary lymph nodes (ypT0/is ypN0) at the time of surgery following completion of neoadjuvant therapy.Metric：Proportion of participants (%)
Measured: At surgery (approximately 18 weeks after initiation of treatment)
Secondary outcomes (6)
Objective Response Rate (ORR) per RECIST v1.1
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1.
Measured: From baseline to surgery (approximately 18 weeks)
Event-Free Survival (EFS)
Time from treatment initiation to the occurrence of disease progression, local or distant recurrence, or death from any cause.Metric：Time-to-event (months).
Measured: From first dose up to 3 years
Breast Conservation Rate
Proportion of participants who undergo breast-conserving surgery after completion of neoadjuvant therapy.
Measured: At surgery (approximately 18 weeks)
Number of Participants With Treatment-Related Adverse Events (TRAEs)
Number of participants experiencing treatment-related adverse events, assessed according to CTCAE version 5.0.
Measured: From first dose to 30 days after last dose
Number of Participants With Grade ≥3 Adverse Events
Number of participants experiencing Grade 3 or higher adverse events according to CTCAE version 5.0.
Measured: From first dose to 30 days after last dose
Number of Participants With Serious Adverse Events (SAEs)
Number of participants experiencing serious adverse events as defined by ICH guidelines.
Measured: From first dose to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (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 Hebei Medical University Fourth 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- All enrolled patients will receive 2 initial cycles of standard neoadjuvant therapy with trastuzumab, pertuzumab, and chemotherapy (THP or TCbHP). Tumor response will then be assessed according to RECIST version 1.1 criteria. Based on early response evaluation, patients will be assigned to subsequent treatment strategies. Patients demonstrating a tumor reduction greater than 40% will continue the same neoadjuvant regimen for an additional 4 cycles. Patients with a tumor reduction of 40% or less will switch to an alternative treatment consisting of SHR-A1811 in combination with pertuzumab for 4 cycles. This response-adapted, sequential assignment design allows treatment modification according to early tumor response, with the aim of optimizing therapeutic outcomes.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Li Ma, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528898
- Sponsor's protocol ID
- OBU-BC-II-279
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, after de-identification, will be made available upon reasonable request. The study protocol, statistical analysis plan, and informed consent form may also be available. Data will be available beginning 6 months after publication and ending 3 years after publication. Requests should be directed to the corresponding author or sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Neoadjuvant SHR-A1811 Combined With Pertuzumab in Patients With HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07528898
- Acronym / sponsor ID
- OBU-BC-II-279
- Conditions
- Breast Cancer
- Keywords
- HER2-positive, Neoadjuvant therapy, Antibody-drug conjugate, SHR-A1811, HER2-targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- May 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 Apr 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.
This is a multicenter, two-arm, exploratory clinical study designed to evaluate the efficacy and safety of a response-guided neoadjuvant treatment strategy in patients with HER2-positive early or locally advanced breast cancer.
Breast cancer is the most common malignancy in women worldwide, and HER2-positive disease accounts for approximately 15-20% of cases and is associated with aggressive tumor biology and a higher risk of recurrence. The introduction of HER2-targeted therapies, including trastuzumab and pertuzumab, has significantly improved patient outcomes. However, a proportion of patients exhibit suboptimal response to standard neoadjuvant therapy, highlighting the need for more effective treatment strategies.
In this study, approximately 100 eligible patients will be enrolled. All patients will initially receive 2 cycles of standard neoadjuvant therapy with trastuzumab, pertuzumab, and chemotherapy (THP or TCbHP). Tumor response will be assessed according to RECIST version 1.1 criteria. Patients with tumor reduction greater than 40% will continue the same regimen for an additional 4 cycles. Patients with tumor reduction of 40% or less will switch to an alternative regimen consisting of SHR-A1811, a novel HER2-targeted antibody-drug conjugate, in combination with pertuzumab for 4 cycles.
SHR-A1811 is an investigational HER2-targeted antibody-drug conjugate designed to deliver a cytotoxic payload directly to tumor cells, potentially overcoming resistance to prior HER2-targeted therapies. Emerging clinical data have demonstrated promising anti-tumor activity and manageable safety in HER2-positive breast cancer.
Clinical data, including baseline characteristics, imaging findings, and pathological markers such as Ki-67, will be collected throughout the study. Efficacy will be evaluated based on imaging assessments according to RECIST 1.1 criteria and pathological response at surgery, while safety will be monitored during treatment.
The primary objective of this study is to explore whether switching to SHR-A1811 in combination with pertuzumab in patients with suboptimal early response can improve pathological complete response (pCR) rates. Secondary objectives include evaluation of safety and tolerability of the treatment strategies.
This study aims to provide evidence for an individualized, response-adapted neoadjuvant treatment approach in HER2-positive breast cancer, and to optimize treatment outcomes for patients with inadequate response to standard therapy.
Detailed description
HER2-positive breast cancer is driven by overexpression or amplification of the HER2 receptor, leading to activation of downstream signaling pathways such as MAPK and PI3K/AKT that promote tumor growth and survival. Although dual HER2 blockade with trastuzumab and pertuzumab in combination with chemotherapy has become a standard neoadjuvant treatment, a subset of patients exhibit insufficient tumor response, indicating biological heterogeneity and potential resistance to therapy.
Pathological complete response (pCR) after neoadjuvant treatment is associated with improved long-term outcomes in HER2-positive breast cancer. Therefore, early identification of patients with suboptimal response and timely treatment modification may represent an effective strategy to improve prognosis.
Antibody-drug conjugates (ADCs) are designed to selectively deliver cytotoxic agents to tumor cells through antigen-specific targeting. SHR-A1811 is an investigational HER2-directed ADC composed of a humanized anti-HER2 monoclonal antibody linked to a topoisomerase I inhibitor payload via a cleavable linker. Preclinical data have demonstrated potent anti-tumor activity in HER2-expressing models, including those with reduced sensitivity to prior HER2-targeted therapies.
Emerging clinical evidence supports the antitumor activity and manageable safety profile of SHR-A1811 in HER2-positive breast cancer. Its mechanism of action suggests potential benefit in patients with inadequate response to standard HER2-targeted neoadjuvant regimens.
This study is designed to investigate a response-adapted treatment strategy, in which early tumor response is used to guide subsequent therapy selection. By incorporating an alternative HER2-targeted approach for patients with suboptimal response, this study aims to explore strategies to improve treatment efficacy while maintaining an acceptable safety profile.
The results of this study are expected to provide evidence to support individualized neoadjuvant treatment strategies for patients with HER2-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All enrolled patients will receive 2 initial cycles of standard neoadjuvant therapy with trastuzumab, pertuzumab, and chemotherapy (THP or TCbHP). Tumor response will then be assessed according to RECIST version 1.1 criteria. Based on early response evaluation, patients will be assigned to subsequent treatment strategies. Patients demonstrating a tumor reduction greater than 40% will continue the same neoadjuvant regimen for an additional 4 cycles. Patients with a tumor reduction of 40% or less will switch to an alternative treatment consisting of SHR-A1811 in combination with pertuzumab for 4 cycles. This response-adapted, sequential assignment design allows treatment modification according to early tumor response, with the aim of optimizing therapeutic outcomes.
| Arm | Type | Receives |
|---|---|---|
| Standard Neoadjuvant Therapy (THP/TCbHP) | Active comparator | Drug: Pertuzumab, Drug: trastuzumab, Drug: ChemotherapyAll enrolled patients will initially receive 2 cycles of standard neoadjuvant therapy with trastuzumab, pertuzumab, and chemotherapy (THP or TCbHP). Patients who achieve a tumor reduction greater than 40% according to RECIST version 1.1 will continue the same regimen for an additional 4 cycles. |
| SHR-A1811 Plus Pertuzumab | Experimental | Drug: SHR-A1811, Drug: PertuzumabAll enrolled patients will initially receive 2 cycles of standard neoadjuvant therapy. Patients with a tumor reduction of 40% or less according to RECIST version 1.1 will switch to SHR-A1811 in combination with pertuzumab for 4 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 and ≤70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion according to RECIST version 1.1.
- Histologically confirmed invasive breast cancer with clinical stage:
- Stage II (T2N0-1M0 or T3N0M0), or Stage III (T2N2-3M0, T3N1-3M0, or T4N0-3M0). 5.HER2-positive invasive breast cancer confirmed by histopathology, defined as: HER2 immunohistochemistry (IHC) 3+, or HER2 IHC 2+ with fluorescence in situ hybridization (FISH) positivity, as determined by the pathology department of the participating center. 6.Adequate organ function, defined as:
Key exclusion criteria (14 listed)
- Prior receipt of any anti-tumor therapy not specified in the study protocol, including but not limited to chemotherapy, radiotherapy, targeted therapy, or endocrine therapy for the current breast cancer.
- Concurrent receipt of any other anti-tumor therapy during the study. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. Stage IV (metastatic) breast cancer.
- History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix.
- Severe dysfunction of major organs, including but not limited to cardiac, hepatic, or renal insufficiency.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment.
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-A1811SHR-A1811 is a HER2-targeted antibody-drug conjugate administered intravenously in combination with pertuzumab as neoadjuvant therapy. | Drug | SHR-A1811 Plus Pertuzumab |
| PertuzumabPertuzumab is a monoclonal antibody targeting HER2, administered intravenously as part of dual HER2 blockade. | Drug | SHR-A1811 Plus Pertuzumab, Standard Neoadjuvant Therapy (THP/TCbHP) |
| trastuzumabTrastuzumab is a HER2-targeted monoclonal antibody administered intravenously as part of standard neoadjuvant therapy. | Drug | Standard Neoadjuvant Therapy (THP/TCbHP) |
| ChemotherapyChemotherapy includes taxane-based regimens with or without carboplatin (THP or TCbHP) administered according to institutional standards. | Drug | Standard Neoadjuvant Therapy (THP/TCbHP) |
Primary outcome
Total Pathological Complete Response (tpCR)
Time frame: At surgery (approximately 18 weeks after initiation of treatment)
Number of participants achieving total pathological complete response, defined as no residual invasive cancer in both breast and axillary lymph nodes (ypT0/is ypN0) at the time of surgery following completion of neoadjuvant therapy.Metric：Proportion of participants (%)
6 secondary outcomes
Objective Response Rate (ORR) per RECIST v1.1
Time frame: From baseline to surgery (approximately 18 weeks)
Event-Free Survival (EFS)
Time frame: From first dose up to 3 years
Breast Conservation Rate
Time frame: At surgery (approximately 18 weeks)
Number of Participants With Treatment-Related Adverse Events (TRAEs)
Time frame: From first dose to 30 days after last dose
Number of Participants With Grade ≥3 Adverse Events
Time frame: From first dose to 30 days after last dose
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose to 30 days after last dose
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 14 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, after de-identification, will be made available upon reasonable request. The study protocol, statistical analysis plan, and informed consent form may also be available. Data will be available beginning 6 months after publication and ending 3 years after publication. Requests should be directed to the corresponding author or sponsor.
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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 SHR-A1811, Pertuzumab and trastuzumab in people with Breast Cancer, run by Hebei Medical University Fourth 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 13 inclusion and 14 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 14 Apr 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 Li Ma, MD (13932116886, mali1021@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pathological Complete Response (tpCR) (time frame: At surgery (approximately 18 weeks after initiation of treatment)). 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 14 Apr 2026.