HER2-positive Breast CancerPhase 2NCT07647263
Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer
A Phase 2 study testing THP Regimen (Taxane + Trastuzumab + Pertuzumab) and Trastuzumab Rezetecan (SHR-A1811) in people with HER2-positive Breast Cancer, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- THP Regimen (Taxane + Trastuzumab + Pertuzumab) and Trastuzumab Rezetecan (SHR-A1811)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2026to Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective contraception during treatment.
- 2.Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2-positive disease defined as: immunohistochemistry (IHC) 3+; or IHC 2+ with confirmed HER2 gene amplification by fluorescence in situ hybridization (FISH).
- 3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- 4.No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
- 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- 6.Ability to understand and provide written informed consent.
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- 7.Adequate organ function as evidenced by the following laboratory values:
- Hemoglobin ≥90 g/L
- White blood cell count ≥3.5×10⁹/L
- Platelet count ≥100×10⁹/L
- Neutrophil count ≥1.5×10⁹/L
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN)
- Total bilirubin ≤1.5×ULN
- Serum creatinine ≤1.5×ULN
- 8.No evidence of myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥55% on echocardiogram; cardiac biomarkers (cardiac troponin I [cTnI] and B-type natriuretic peptide [BNP]) within normal limits.
- 9.All required baseline laboratory and radiologic examinations completed prior to neoadjuvant therapy.
- 10.No dysphagia.
- 11.Availability of complete clinical data.
Who cannot join
- 1.Male breast cancer or inflammatory breast cancer.
- 2.Metastatic breast cancer (Stage IV).
- 3.Presence of other concurrent malignancies or history of malignancy other than breast cancer within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- 4.Receipt of any other concurrent anti-cancer therapy or participation in another clinical trial.
- 5.Presence of severe non-malignant disease that would compromise patient compliance or place the patient at unacceptable risk.
- 6.Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipated need for major surgery during the study period.
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- 7.Receipt of radiotherapy, chemotherapy, molecular targeted therapy, endocrine therapy, or major breast surgery for breast cancer within 4 weeks prior to study treatment; current or prior use of HER2-targeted monoclonal antibodies, HER2-targeted antibody-drug conjugates (ADCs), or tyrosine kinase inhibitors (TKIs).
- 8.History of hypersensitivity or contraindication to any component of the study drugs.
- 9.Poorly controlled cardiac symptoms or diseases, including: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Dementia, intellectual disability, or any psychiatric disorder that impairs the ability to understand the informed consent form.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: An Interventional, Multicenter Study of Trastuzumab Rezetecan as Neoadjuvant Therapy in Patients With THP-Insensitive HER2-Positive Early Breast Cancer
This study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab. After the initial 2-cycle treatment, tumor response will be evaluated by radiologic imaging and patient-derived organoid (PDO) drug sensitivity testing.
Patients with an inadequate response to THP are defined as those with <50% tumor size reduction on imaging, or failure to reach the PDO sensitivity threshold (<80% tumor cell killing for HER2+/HR- tumors; <60% for HER2+/HR+ tumors). These non-responders will switch to receive 4 cycles of trastuzumab rezetecan (SHR-A1811), a novel HER2-targeted antibody-drug conjugate (ADC). Patients with a favorable response (≥50% tumor reduction or meeting the PDO threshold) will continue with an additional 4 cycles of THP.
Read more
The primary objective is to evaluate the pathologic complete response (pCR) rate in THP non-responders after switching to trastuzumab rezetecan. Secondary objectives include objective response rate (ORR), event-free survival (EFS), overall survival (OS), 3-year invasive disease-free survival (iDFS), and safety profiles of both treatment strategies. Outcomes in patients who continue THP will be described for exploratory purposes.
A total of 124 patients will be enrolled. This response-adapted, individualized strategy aims to provide an effective option for HER2-positive breast cancer patients with an inadequate early response to conventional THP neoadjuvant therapy.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- THP Regimen (Taxane + Trastuzumab + Pertuzumab), Trastuzumab Rezetecan (SHR-A1811)
- Keywords
- Breast Cancer, HER2-positive, Neoadjuvant therapy, Trastuzumab rezetecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THP Regimen (Taxane + Trastuzumab + Pertuzumab)Drug
Neoadjuvant combination therapy consisting of a taxane, trastuzumab, and pertuzumab. Administered as initial treatment to all patients, and continued for responders.
Trastuzumab Rezetecan (SHR-A1811)Drug
HER2-targeted antibody-drug conjugate (ADC). Administered to patients with inadequate response to initial THP therapy.
| Study group | Role | What they receive |
|---|---|---|
| THP Continuation Arm | Active comparator | All patients first receive 2 cycles of neoadjuvant THP (taxane + trastuzumab + pertuzumab). Patients with favorable response (≥50% tumor reduction or meeting PDO sensitivity threshold) continue with 4 additional cycles of THP. Receives: Drug: THP Regimen (Taxane + Trastuzumab + Pertuzumab) |
| SHR-A1811 Switch Arm | Experimental | All patients first receive 2 cycles of neoadjuvant THP (taxane + trastuzumab + pertuzumab). Patients with inadequate response (<50% tumor reduction or failing PDO sensitivity threshold) switch to 4 cycles of trastuzumab rezetecan (SHR-A1811). Receives: Drug: THP Regimen (Taxane + Trastuzumab + Pertuzumab); Drug: Trastuzumab Rezetecan (SHR-A1811) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (tpCR) Rate
Proportion of patients achieving pathologic complete response (tpCR), defined as the absence of invasive carcinoma in both the breast primary lesion and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy and surgery. Ductal carcinoma in situ (DCIS) is allowed.
Measured: Perioperative
Secondary outcomes (4)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST version 1.1 criteria.
Measured: Up to 24 weeks
Event-Free Survival (EFS)
Time from study enrollment to the first occurrence of invasive disease recurrence (local, regional, or distant), death from any cause, or contralateral invasive breast cancer.
Measured: From study enrollment up to 3 years after the last patient is enrolled
Overall Survival (OS)
Time from study enrollment to death from any cause.
Measured: From study enrollment up to 5 years after the last patient is enrolled
3-Year Invasive Disease-Free Survival (iDFS) Rate
Proportion of patients alive and free from invasive breast cancer recurrence (local, regional, or distant) or contralateral invasive breast cancer at 3 years after study enrollment.
Measured: 3 years after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start24 Mar 2026
- Primary completionJun 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Zhou, The First Affiliated Hospital of Soochow University
- Investigators
- Zhaoji Guo, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647263
- Sponsor's protocol ID
- 26-OBU-JS-BC-II-016
- Status last verified
- May 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Multicenter Study of Trastuzumab Rezetecan as Neoadjuvant Therapy in Patients With THP-Insensitive HER2-Positive Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07647263
- Acronym / sponsor ID
- 26-OBU-JS-BC-II-016
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Breast Cancer, HER2-positive, Neoadjuvant therapy, Trastuzumab rezetecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 15 Jun 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 study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab. After the initial 2-cycle treatment, tumor response will be evaluated by radiologic imaging and patient-derived organoid (PDO) drug sensitivity testing.
Patients with an inadequate response to THP are defined as those with <50% tumor size reduction on imaging, or failure to reach the PDO sensitivity threshold (<80% tumor cell killing for HER2+/HR- tumors; <60% for HER2+/HR+ tumors). These non-responders will switch to receive 4 cycles of trastuzumab rezetecan (SHR-A1811), a novel HER2-targeted antibody-drug conjugate (ADC). Patients with a favorable response (≥50% tumor reduction or meeting the PDO threshold) will continue with an additional 4 cycles of THP.
The primary objective is to evaluate the pathologic complete response (pCR) rate in THP non-responders after switching to trastuzumab rezetecan. Secondary objectives include objective response rate (ORR), event-free survival (EFS), overall survival (OS), 3-year invasive disease-free survival (iDFS), and safety profiles of both treatment strategies. Outcomes in patients who continue THP will be described for exploratory purposes.
A total of 124 patients will be enrolled. This response-adapted, individualized strategy aims to provide an effective option for HER2-positive breast cancer patients with an inadequate early response to conventional THP neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THP Continuation Arm | Active comparator | Drug: THP Regimen (Taxane + Trastuzumab + Pertuzumab)All patients first receive 2 cycles of neoadjuvant THP (taxane + trastuzumab + pertuzumab). Patients with favorable response (≥50% tumor reduction or meeting PDO sensitivity threshold) continue with 4 additional cycles of THP. |
| SHR-A1811 Switch Arm | Experimental | Drug: THP Regimen (Taxane + Trastuzumab + Pertuzumab), Drug: Trastuzumab Rezetecan (SHR-A1811)All patients first receive 2 cycles of neoadjuvant THP (taxane + trastuzumab + pertuzumab). Patients with inadequate response (<50% tumor reduction or failing PDO sensitivity threshold) switch to 4 cycles of trastuzumab rezetecan (SHR-A1811). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1.Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective contraception during treatment.
- 2.Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2-positive disease defined as: immunohistochemistry (IHC) 3+; or IHC 2+ with confirmed HER2 gene amplification by fluorescence in situ hybridization (FISH).
- 3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- 4.No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
- 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (10 listed)
- 1.Male breast cancer or inflammatory breast cancer.
- 2.Metastatic breast cancer (Stage IV).
- 3.Presence of other concurrent malignancies or history of malignancy other than breast cancer within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- 4.Receipt of any other concurrent anti-cancer therapy or participation in another clinical trial.
- 5.Presence of severe non-malignant disease that would compromise patient compliance or place the patient at unacceptable risk.
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 |
|---|---|---|
| THP Regimen (Taxane + Trastuzumab + Pertuzumab)Neoadjuvant combination therapy consisting of a taxane, trastuzumab, and pertuzumab. Administered as initial treatment to all patients, and continued for responders. | Drug | SHR-A1811 Switch Arm, THP Continuation Arm |
| Trastuzumab Rezetecan (SHR-A1811)HER2-targeted antibody-drug conjugate (ADC). Administered to patients with inadequate response to initial THP therapy. | Drug | SHR-A1811 Switch Arm |
Primary outcome
Pathologic Complete Response (tpCR) Rate
Time frame: Perioperative
Proportion of patients achieving pathologic complete response (tpCR), defined as the absence of invasive carcinoma in both the breast primary lesion and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy and surgery. Ductal carcinoma in situ (DCIS) is allowed.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 weeks
Event-Free Survival (EFS)
Time frame: From study enrollment up to 3 years after the last patient is enrolled
Overall Survival (OS)
Time frame: From study enrollment up to 5 years after the last patient is enrolled
3-Year Invasive Disease-Free Survival (iDFS) Rate
Time frame: 3 years after study enrollment
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 15 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Zhaoji Guo study chair
The First Affiliated Hospital of Soochow University
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 THP Regimen (Taxane + Trastuzumab + Pertuzumab) and Trastuzumab Rezetecan (SHR-A1811) in people with HER2-positive Breast Cancer, run by The First Affiliated Hospital of Soochow 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 18 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: looking for participants now, as of the sponsor's last update on 15 Jun 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 Hao Zhou (+8613862097709, dlou515@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (tpCR) Rate (time frame: Perioperative). 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 15 Jun 2026.