HER2-positive Breast CancerPhase 2NCT07635342
Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer
A Phase 2 study testing Pyrotinib Maleate, Trastuzumab (H, 8mg/kg and pegylated liposomal doxorubicin hydrochloride in people with HER2-positive Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Pyrotinib Maleate, Trastuzumab (H, 8mg/kg and pegylated liposomal doxorubicin hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 31 Dec 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 65 years.
- Patients with previously untreated invasive breast cancer confirmed by pathological examination.
- HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.
- Clinical stage T2N0-3M0 or any T/N1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
- At least one measurable lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Adequate organ function, meeting all of the following criteria:
- Hemoglobin ≥100 g/L.
- Absolute neutrophil count ≥1.5 × 10^9/L.
- Platelet count ≥100 × 10^9/L.
- Total bilirubin ≤1 × upper limit of normal (ULN).
- Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN.
- Alkaline phosphatase ≤2.5 × ULN.
- Blood urea nitrogen and serum creatinine ≤1.5 × ULN.
- Left ventricular ejection fraction ≥55% by echocardiography.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last dose of study treatment.
- Patients must voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Who cannot join
- Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.
- Concurrent receipt of any other anti-tumor therapy.
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
- Stage IV breast cancer.
- Breast cancer not confirmed by pathological examination.
- History of other malignancies within 5 years, except cured carcinoma in situ of the cervix.
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- Severe dysfunction of major organs, including the heart, liver, or kidney.
- Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that may affect drug administration or absorption.
- Participation in another drug clinical trial within 4 weeks before enrollment.
- Known history of allergy to any component of the study treatment.
- History of immunodeficiency, including positive HIV test, hepatitis C virus infection, active hepatitis B virus infection, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- History of any cardiac disease, including clinically significant arrhythmia requiring medication, myocardial infarction, heart failure, or any other cardiac disease judged by the investigator to make the patient unsuitable for this study.
- Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception throughout the study.
- Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or affect completion of the study, including but not limited to uncontrolled severe hypertension, severe diabetes mellitus, or active infection.
- Clear history of neurological or psychiatric disorders, including epilepsy or dementia.
- Any other condition that, in the investigator's opinion, makes the patient 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.
Lina Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Zhenchuan Song, MD, 185 31117857, songzhch@hotmail.com
About this study
Official title: Efficacy and Safety of Pyrotinib and Trastuzumab Combined With Pegylated Liposomal Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel for Injection Albumin Bound as Neoadjuvant Therapy for Early HER2-Positive Breast Cancer
This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer.
Eligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pyrotinib Maleate, Trastuzumab (H, 8mg/kg, pegylated liposomal doxorubicin hydrochloride, Cyclophosphamide, Paclitaxel for Injection Albumin Bound
- Keywords
- Neoadjuvant Therapy, Pyrotinib, Trastuzumab, Pathological Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib MaleateDrug
Pyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. It should be taken within 30 minutes after breakfast and continued throughout the neoadjuvant treatment period.
Trastuzumab (H, 8mg/kgDrug
Trastuzumab will be administered intravenously at a loading dose of 8 mg/kg on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent 3-week cycle during neoadjuvant treatment.
pegylated liposomal doxorubicin hydrochlorideDrug
Pegylated liposomal doxorubicin hydrochloride will be administered intravenously at 35 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment.
CyclophosphamideDrug
Cyclophosphamide will be administered intravenously at 600 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment in combination with pegylated liposomal doxorubicin hydrochloride, pyrotinib, and trastuzumab.
Paclitaxel for Injection Albumin BoundDrug
Paclitaxel for injection albumin bound will be administered intravenously at 230-260 mg/m² on Day 1 of each 3-week cycle for the subsequent 4 cycles of neoadjuvant treatment in combination with pyrotinib and trastuzumab.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy | Experimental | Participants will receive 8 cycles of neoadjuvant treatment. Pyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. Trastuzumab will be administered intravenously at a loading dose of 8 mg/kg in Cycle 1, followed by 6 mg/kg on Day 1 of each 3-week cycle. During the first 4 cycles, participants will receive pegylated liposomal doxorubicin hydrochloride 35 mg/m² and cyclophosphamide 600 mg/m² intravenously on Day 1 of each 3-week cycle. During the subsequent 4 cycles, participants will receive paclitaxel for injection albumin bound 230-260 mg/m² intravenously on Day 1 of each 3-week cycle. Receives: Drug: Pyrotinib Maleate; Drug: Trastuzumab (H, 8mg/kg; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: Cyclophosphamide; Drug: Paclitaxel for Injection Albumin Bound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pathological Complete Response Rate
Total pathological complete response is defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes after neoadjuvant therapy.
Measured: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Secondary outcomes (7)
Secondary Outcome Measure
Breast pathological complete response is defined as the absence of residual invasive cancer in the breast after neoadjuvant therapy.
Measured: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Lymph Node Pathological Complete Response Rate
Lymph node pathological complete response is defined as the absence of residual invasive cancer in axillary lymph nodes after neoadjuvant therapy.
Measured: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Objective Response Rate
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST version 1.1 during neoadjuvant therapy.
Measured: From baseline to completion of neoadjuvant therapy, approximately 24 weeks
Event-Free Survival
Event-free survival is defined as the time from enrollment to disease progression, recurrence, distant metastasis, second primary malignancy, or death from any cause, whichever occurs first.
Measured: From enrollment to the first documented event or death, assessed up to 3 years
Distant Disease-Free Survival
Distant disease-free survival is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Measured: From enrollment to distant metastasis or death, assessed up to 3 years
Overall Survival
Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive will be censored at the date of last follow-up.
Measured: From enrollment to death from any cause, assessed up to 3 years
Number of Participants With Adverse Events
Safety will be assessed by the incidence and severity of adverse events, graded according to NCI CTCAE version 5.0.
Measured: From the first dose of study treatment to 30 days after the last dose of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start30 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2-positive 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the same single-arm neoadjuvant treatment regimen consisting of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide for 4 cycles, followed by paclitaxel for injection albumin bound combined with pyrotinib and trastuzumab for 4 cycles.
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenchuan Song, Hebei Medical University Fourth Hospital
- Investigators
- Zhenchuan Song, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635342
- Sponsor's protocol ID
- OBU-BC-II-167
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy protection, ethical considerations, and the absence of a pre-specified individual participant data sharing plan in the current study protocol.
Publications
Xuhong J, Qi X, Tang P, Fan L, Chen L, Zhang F, Tan X, Yan W, Zhong L, He C, Liang Y, Ren L, Wang M, Zhang Y, Jiang J. Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1909-e1920. doi: 10.1002/onco.13546. Epub 2020 Oct 20.
PubMed 33000490
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pyrotinib and Trastuzumab Combined With Pegylated Liposomal Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel for Injection Albumin Bound as Neoadjuvant Therapy for Early HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07635342
- Acronym / sponsor ID
- OBU-BC-II-167
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Neoadjuvant Therapy, Pyrotinib, Trastuzumab, Pathological Complete Response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 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 is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer.
Eligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the same single-arm neoadjuvant treatment regimen consisting of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide for 4 cycles, followed by paclitaxel for injection albumin bound combined with pyrotinib and trastuzumab for 4 cycles.
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy | Experimental | Drug: Pyrotinib Maleate, Drug: Trastuzumab (H, 8mg/kg, Drug: pegylated liposomal doxorubicin hydrochloride, Drug: Cyclophosphamide, Drug: Paclitaxel for Injection Albumin BoundParticipants will receive 8 cycles of neoadjuvant treatment. Pyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. Trastuzumab will be administered intravenously at a loading dose of 8 mg/kg in Cycle 1, followed by 6 mg/kg on Day 1 of each 3-week cycle. During the first 4 cycles, participants will receive pegylated liposomal doxorubicin hydrochloride 35 mg/m² and cyclophosphamide 600 mg/m² intravenously on Day 1 of each 3-week cycle. During the subsequent 4 cycles, participants will receive paclitaxel for injection albumin bound 230-260 mg/m² intravenously on Day 1 of each 3-week cycle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female patients aged 18 to 65 years.
- Patients with previously untreated invasive breast cancer confirmed by pathological examination.
- HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.
- Clinical stage T2N0-3M0 or any T/N1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
- At least one measurable lesion according to RECIST version 1.1.
Key exclusion criteria (16 listed)
- Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.
- Concurrent receipt of any other anti-tumor therapy.
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
- Stage IV breast cancer.
- Breast cancer not confirmed by pathological examination.
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 MaleatePyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. It should be taken within 30 minutes after breakfast and continued throughout the neoadjuvant treatment period. | Drug | Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy |
| Trastuzumab (H, 8mg/kgTrastuzumab will be administered intravenously at a loading dose of 8 mg/kg on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent 3-week cycle during neoadjuvant treatment. | Drug | Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy |
| pegylated liposomal doxorubicin hydrochloridePegylated liposomal doxorubicin hydrochloride will be administered intravenously at 35 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment. | Drug | Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy |
| CyclophosphamideCyclophosphamide will be administered intravenously at 600 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment in combination with pegylated liposomal doxorubicin hydrochloride, pyrotinib, and trastuzumab. | Drug | Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy |
| Paclitaxel for Injection Albumin BoundPaclitaxel for injection albumin bound will be administered intravenously at 230-260 mg/m² on Day 1 of each 3-week cycle for the subsequent 4 cycles of neoadjuvant treatment in combination with pyrotinib and trastuzumab. | Drug | Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy |
Primary outcome
Total Pathological Complete Response Rate
Time frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Total pathological complete response is defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes after neoadjuvant therapy.
7 secondary outcomes
Secondary Outcome Measure
Time frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Lymph Node Pathological Complete Response Rate
Time frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Objective Response Rate
Time frame: From baseline to completion of neoadjuvant therapy, approximately 24 weeks
Event-Free Survival
Time frame: From enrollment to the first documented event or death, assessed up to 3 years
Distant Disease-Free Survival
Time frame: From enrollment to distant metastasis or death, assessed up to 3 years
Overall Survival
Time frame: From enrollment to death from any cause, assessed up to 3 years
Number of Participants With Adverse Events
Time frame: From the first dose of study treatment to 30 days after the last dose of neoadjuvant treatment
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 9 Jun 2026.
- Background: PubMed 33000490Xuhong J, Qi X, Tang P, Fan L, Chen L, Zhang F, Tan X, Yan W, Zhong L, He C, Liang Y, Ren L, Wang M, Zhang Y, Jiang J. Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1909-e1920. doi: 10.1002/onco.13546. Epub 2020 Oct 20.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy protection, ethical considerations, and the absence of a pre-specified individual participant data sharing plan in the current study protocol.
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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.
Lina Zhang, MD contact
Zhenchuan Song principal investigator
Hebei Medical University Fourth Hospital
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 Maleate, Trastuzumab (H, 8mg/kg and pegylated liposomal doxorubicin hydrochloride in people with HER2-positive 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 17 inclusion and 16 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 9 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 Zhenchuan Song, MD (18531117857, songzhch@hotmail.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 Rate (time frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07635342, which also lists 1 linked publication.
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 9 Jun 2026.