HER2-positive Breast CancerPhase 2NCT06832904
Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)
A Phase 2 study testing pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy in people with HER2-positive Breast Cancer and Neoadjuvant Therapy, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR）and clinical complete response（cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Neoadjuvant Therapy, Pyrotinib
- What is being tested?
- pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to Jan 2030
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Female patients aged 18-75 years old; 2. ECOG score is 0-1 points; 3. Histologically confirmed invasive cancer meets the following standards:
- T1N1-3M0 or T2-4N0M0
- All patients were pathohistologically confirmed as HER2+ breast cancer. HER2 positivity was determined locally and defned as 3+ staining intensity by immunohistochemistry or HER2 gene amplifcation by fuorescence in situ hybridization according to the 2013 American Society of Clinical Oncology/College of American Pathologists guidelines.
- 4. The functional level of major organs must meet the following requirements (no blood transfusion, no use of leukocyte and platelet boosting drugs within 2 weeks before screening):
- Blood routine: Absolute neutrophil count (ANC) greater than 1.5 × 109/L; platelet count (PLT) greater than 75 × 109/L; Hemoglobin (Hb) is greater than 90g/L; Lymphocyte count ≥ 1.5 × 109/L
- Blood biochemistry: Total bilirubin (TBIL) is less than 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate (AST) levels are less than 1.5 × ULN; Alkaline phosphatase is less than 2.5 × ULN; Urea nitrogen/Urea (BUN/UREA) and creatinine (Cr) are less than 1.5 × ULN.
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- Cardiac ultrasound: Left ventricular ejection fraction (LVEF) greater than 55%.
- 12 lead electrocardiogram: The Fridericia corrected QT interval (QTcF) is less than 470 milliseconds 5. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.
- 6. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
Who cannot join
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.
- Serious heart disease or discomfort, including but not limited to the following diseases:
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- 1) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).
- 2) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).
- 3) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 100mmHg after drug treatment).
- 7. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
- 8. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment [HBV-DNA test negative or\<50IU/ml] and cured hepatitis C patients [HCV RNA test negative]).
- 9. Individuals with a known history of allergies to the components of this medication regimen.
- 10. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication.
- 11. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate 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.
Jin-fei Ma contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhi-jun Dai, 86-15705819132, dzj0911@126.com
Dai
About this study
Official title: Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05): A Prospective, Single-arm, Multi-center Clinical Study
This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR）and clinical complete response（cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR). The study also observes the incidence and types of adverse events.
- Conditions
- HER2-positive Breast Cancer, Neoadjuvant Therapy, Pyrotinib
- Being tested
- pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapyDrug
Receive four neoadjuvant cycles of oral pyrotinib (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) , nab-paclitaxel (260 mg/m2) and carboplatin（AUC=5）every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Not described Receives: Drug: pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response（pCR）
Measured: 2 years
clinical complete response（cCR)
Measured: 2 years
Secondary outcomes (4)
RCB 0-1 ratio
Measured: 2 years
disease-free survival (DFS)
Measured: 3 years
progression-free survival (PFS)
Measured: 3 years
objective response rate (ORR)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start3 Dec 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (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 First Affiliated Hospital of Zhejiang 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832904
- Sponsor's protocol ID
- IIT20240161C-R1
- Status last verified
- Dec 2024
- First submitted
- 13 Feb 2025
- Last updated
- 18 Feb 2025
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05): A Prospective, Single-arm, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT06832904
- Acronym / sponsor ID
- IIT20240161C-R1
- Conditions
- HER2-positive Breast Cancer, Neoadjuvant Therapy, Pyrotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR）and clinical complete response（cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR). The study also observes the incidence and types of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Drug: pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Female patients aged 18-75 years old; 2. ECOG score is 0-1 points; 3. Histologically confirmed invasive cancer meets the following standards:
- T1N1-3M0 or T2-4N0M0
- All patients were pathohistologically confirmed as HER2+ breast cancer. HER2 positivity was determined locally and defned as 3+ staining intensity by immunohistochemistry or HER2 gene amplifcation by fuorescence in situ hybridization according to the 2013 American Society of Clinical Oncology/College of American Pathologists guidelines.
- 4. The functional level of major organs must meet the following requirements (no blood transfusion, no use of leukocyte and platelet boosting drugs within 2 weeks before screening):
- 6. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
Key exclusion criteria (14 listed)
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.
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 |
|---|---|---|
| pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapyReceive four neoadjuvant cycles of oral pyrotinib (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) , nab-paclitaxel (260 mg/m2) and carboplatin（AUC=5）every 3 weeks. | Drug | single-arm |
Primary outcome
pathologic complete response（pCR）
Time frame: 2 years
clinical complete response（cCR)
Time frame: 2 years
4 secondary outcomes
RCB 0-1 ratio
Time frame: 2 years
disease-free survival (DFS)
Time frame: 3 years
progression-free survival (PFS)
Time frame: 3 years
objective response rate (ORR)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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.
Jin-fei Ma contact
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 pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy in people with HER2-positive Breast Cancer and Neoadjuvant Therapy, run by First Affiliated Hospital of Zhejiang 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 9 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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 Zhi-jun Dai (86-15705819132, dzj0911@126.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: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.