Breast CancerPhase 2/3NCT04290793
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
A Phase 2/3 study testing Pyrotinib, Epirubicin and Cyclophosphamide in people with Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib, Epirubicin and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 10 Dec 2026
- Phase
- Phase 2/3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female breast cancer patients at the age of >= 18 years and <= 70 years who received first treatment；
- Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
- According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
- The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
- The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
- Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
- A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Who cannot join
- Known history of hypersensitivity to pyrotinib or any of it components;
- Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
- Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
- Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
- Patients with severe heart disease or discomfort who cannot be treated;
- The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
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- Pregnant or lactating women;
- Less than 4 weeks from the last clinical trial;
- Patients participating in other clinical trials at the same time
- The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pyrotinib Combined With Epirubicin and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab in Neoadjuvant Therapy of HER2-positive Early Breast Cancer: a Single-arm, Open-label, Multicenter Phase II Clinical Trial
This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib, Epirubicin, Cyclophosphamide, Taxanes, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
400mg administered as continuous oral once daily from the first day of the study
EpirubicinDrug
90mg/m^2 d1 iv Q2W for 4 cycles
CyclophosphamideDrug
600 mg/m^2 d1 iv Q2W for 4 cycles
TaxanesDrug
Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )
TrastuzumabBiological
the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib Receives: Drug: Pyrotinib; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Taxanes; Biological: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
Measured: immediately after surgery
Secondary outcomes (4)
Objective Response Rate(ORR)
Baseline to measured stable disease
Measured: 2 years
Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause
Baseline to measured date of recurrence or death from any cause
Measured: 3 years
bpCR
After neoadjuvant chemotherapy and surgery, breast was free of any invasive cancer
Measured: immediately after surgery
Adverse Events rate
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Mar 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion10 Dec 2026 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yunjiang, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290793
- Sponsor's protocol ID
- HRHB-CB001
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2020
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrotinib Combined With Epirubicin and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab in Neoadjuvant Therapy of HER2-positive Early Breast Cancer: a Single-arm, Open-label, Multicenter Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04290793
- Acronym / sponsor ID
- HRHB-CB001
- Conditions
- Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 2 Mar 2020 (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 prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Drug: Pyrotinib, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Taxanes, Biological: TrastuzumabPatients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female breast cancer patients at the age of >= 18 years and <= 70 years who received first treatment；
- Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
- According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
- The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
- The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
Key exclusion criteria (10 listed)
- Known history of hypersensitivity to pyrotinib or any of it components;
- Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
- Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
- Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
- Patients with severe heart disease or discomfort who cannot be treated;
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 |
|---|---|---|
| Pyrotinib400mg administered as continuous oral once daily from the first day of the study | Drug | Experimental group |
| Epirubicin90mg/m^2 d1 iv Q2W for 4 cycles | Drug | Experimental group |
| Cyclophosphamide600 mg/m^2 d1 iv Q2W for 4 cycles | Drug | Experimental group |
| TaxanesAlbumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles ) | Drug | Experimental group |
| Trastuzumabthe first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W | Biological | Experimental group |
Primary outcome
tpCR
Time frame: immediately after surgery
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
4 secondary outcomes
Objective Response Rate(ORR)
Time frame: 2 years
Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause
Time frame: 3 years
bpCR
Time frame: immediately after surgery
Adverse Events rate
Time frame: 1-year
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 7 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pyrotinib, Epirubicin and Cyclophosphamide 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 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 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 combined 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tpCR (time frame: immediately after surgery). 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 7 Jan 2026.