Breast CancerPhase 3NCT07528716
Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy
A Phase 3 study testing SHR- A1811, PCbHP and SHR- A1811+ Pyrotinib in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR- A1811, PCbHP and SHR- A1811+ Pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to Jun 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
- Female patients aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Histologically confirmed unilateral primary invasive breast cancer, staged as at least cT2 or cN1 (i.e., AJCC 8th edition stage II-III), and M0.
- Pathologically confirmed HER2-positive breast cancer, defined as HER2 IHC 3+, or IHC 2+ with positive in situ hybridization (ISH).
- At least one measurable lesion according to RECIST version 1.1.
- Adequate major organ function, meeting all of the following criteria: Hematology criteria (without blood transfusion or hematopoietic growth factor support within 7 days before screening): hemoglobin (HB) >= 90 g/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet count (PLT) >= 75 x 10^9/L.
Show all 10Show fewer
- Biochemistry criteria: total bilirubin (TBIL) <= 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x ULN; serum creatinine (Cr) <= 1.5 x ULN; endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault formula).
- 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 msec; echocardiography: left ventricular ejection fraction (LVEF) >= 55%.
- Women of childbearing potential must use at least one medically accepted contraceptive method during study treatment and for at least 3 months after the last dose of study drug.
- Subjects must voluntarily participate in the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Who cannot join
- Bilateral breast cancer, inflammatory breast cancer, or clinically stage IV (metastatic) breast cancer.
- Any prior systemic targeted therapy, chemotherapy, endocrine therapy, biologic therapy, radiotherapy, or immunotherapy for any reason.
- Any of the following comorbidities, medical histories, or treatment histories:
- Known or suspected interstitial pneumonitis; or moderate to severe pulmonary disease severely affecting respiratory function, such as severe asthma or severe chronic obstructive pulmonary disease (COPD).
- Serious cardiovascular or cerebrovascular disease, including but not limited to New York Heart Association (NYHA) class II or higher heart failure (including class II), myocardial infarction or cerebrovascular accident (including cerebral ischemia or symptomatic cerebral infarction) within 3 months before first dosing, or persistent arrhythmia of grade >= 2.
- Severe systemic infection (e.g., requiring intravenous antibiotics, antifungal agents, or antiviral drugs according to clinical practice standards), or unexplained fever > 38.5 degrees C during screening or before first dosing.
Show all 12Show fewer
- Clinically significant bleeding symptoms within 1 month before signing informed consent, or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or baseline fecal occult blood of ++ or above.
- Known hypersensitivity or intolerance to the investigational medicinal products or their excipients.
- Any other malignancy within the previous 5 years, except cured cervical carcinoma in situ or non-melanoma skin cancer.
- Pregnancy or lactation, or refusal by women of childbearing potential to use appropriate contraception during the trial.
- Participation in another clinical trial within 30 days before the first dose of study drug.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the 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, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Zhimin Shao, MD.PhD, 18017312288, zhimingshao@yahoo.com
About this study
Official title: Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy: A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study
Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- SHR- A1811, PCbHP, SHR- A1811+ Pyrotinib
- Keywords
- breast cancer, HER2-positive, early
- 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
the experimental group consists of different neoadjuvant treatment regimens matched by the artificial intelligence model
PCbHPDrug
Standard neoadjuvant treatment regimen for HER2-positive breast cancer
SHR- A1811+ PyrotinibDrug
the investigational arm consists of different neoadjuvant treatment regimens matched by the artificial intelligence model
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: SHR- A1811; Drug: PCbHP; Drug: SHR- A1811+ Pyrotinib |
| control group | Active comparator | Not described Receives: Drug: PCbHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic Complete Response (pCR)
pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
Measured: through study completion, up to 24 weeks
Secondary outcomes (1)
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: up to 24 weeks
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 start6 May 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (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 Fudan UniversityThe 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, Controlled, Open-Label, Multicenter Phase III
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528716
- Sponsor's protocol ID
- SCHBCC-N0114
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy: A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT07528716
- Acronym / sponsor ID
- SCHBCC-N0114
- Conditions
- Breast Cancer
- Keywords
- breast cancer, HER2-positive, early
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (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.
Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Controlled, Open-Label, Multicenter Phase III
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: SHR- A1811, Drug: PCbHP, Drug: SHR- A1811+ Pyrotinib |
| control group | Active comparator | Drug: PCbHP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Histologically confirmed unilateral primary invasive breast cancer, staged as at least cT2 or cN1 (i.e., AJCC 8th edition stage II-III), and M0.
- Pathologically confirmed HER2-positive breast cancer, defined as HER2 IHC 3+, or IHC 2+ with positive in situ hybridization (ISH).
- At least one measurable lesion according to RECIST version 1.1.
Key exclusion criteria (12 listed)
- Bilateral breast cancer, inflammatory breast cancer, or clinically stage IV (metastatic) breast cancer.
- Any prior systemic targeted therapy, chemotherapy, endocrine therapy, biologic therapy, radiotherapy, or immunotherapy for any reason.
- Any of the following comorbidities, medical histories, or treatment histories:
- Known or suspected interstitial pneumonitis; or moderate to severe pulmonary disease severely affecting respiratory function, such as severe asthma or severe chronic obstructive pulmonary disease (COPD).
- Serious cardiovascular or cerebrovascular disease, including but not limited to New York Heart Association (NYHA) class II or higher heart failure (including class II), myocardial infarction or cerebrovascular accident (including cerebral ischemia or symptomatic cerebral infarction) within 3 months before first dosing, or persistent arrhythmia of grade >= 2.
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- A1811the experimental group consists of different neoadjuvant treatment regimens matched by the artificial intelligence model | Drug | experimental group |
| PCbHPStandard neoadjuvant treatment regimen for HER2-positive breast cancer | Drug | control group, experimental group |
| SHR- A1811+ Pyrotinibthe investigational arm consists of different neoadjuvant treatment regimens matched by the artificial intelligence model | Drug | experimental group |
Primary outcome
pathologic Complete Response (pCR)
Time frame: through study completion, up to 24 weeks
pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
1 secondary outcome
Objective Response Rate (ORR)
Time frame: up to 24 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 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for 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
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
RecruitingPhase 3
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
Breast Cancer
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingObservational study
Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT
Breast Cancer
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 SHR- A1811, PCbHP and SHR- A1811+ Pyrotinib in people with Breast Cancer, run by Fudan University 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 10 inclusion and 12 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 8 Jul 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 Zhimin Shao, MD.PhD (18017312288, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic Complete Response (pCR) (time frame: through study completion, up to 24 weeks). 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 8 Jul 2026.