Locally Advanced Breast CancerPhase 3ATPNCT04254263
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
A Phase 3 study testing pyrotinib in people with Locally Advanced Breast Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Breast Cancer
- What is being tested?
- pyrotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2019to Aug 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, Aged ≥18 and ≤70 years;
- Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
- Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
- Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
- Been or being treated for early breast cancer with standard of care duration of trastuzumab;
- Adjuvant treatment regimen needs to be determined before randomization;
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- Duration from Random time to the last use of trastuzumab≤1 year.
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms
- Signed informed consent form (ICF) .
Who cannot join
- Metastatic disease (Stage IV) ;
- Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
- Progressive disease during neoadjuvant therapy;
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
- Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
- Less than 4 weeks from the last clinical trial;
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- History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
- Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial;
- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of 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
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Jinsong Lu, MD, lujjss@163.com
About this study
Official title: Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy
This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
- Conditions
- Locally Advanced Breast Cancer
- Being tested
- pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinibDrug
pyrotinib 400 mg, orally once daily for one year
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib | Experimental | pyrotinib 400 mg, orally once daily for one year Receives: Drug: pyrotinib |
| No Pyrotinib | No intervention | Observation follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-free Survival (iDFS)
Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Measured: From randomization until time of event up to 2 years.
Secondary outcomes (2)
Disease-free Survival (DFS)
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause
Measured: From randomization until time of event up to 2 years
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Measured: From randomization until time of event up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start16 Dec 2019
- Primary completionAug 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Jinsong Lu, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254263
- Sponsor's protocol ID
- KY2019-070
- Acronym
- ATP
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2020
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy
- ClinicalTrials.gov ID
- NCT04254263
- Acronym / sponsor ID
- ATP / KY2019-070
- Conditions
- Locally Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Feb 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, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib | Experimental | Drug: pyrotinibpyrotinib 400 mg, orally once daily for one year |
| No Pyrotinib | No intervention | –Observation follow-up |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female, Aged ≥18 and ≤70 years;
- Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
- Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
- Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
- Been or being treated for early breast cancer with standard of care duration of trastuzumab;
Key exclusion criteria (10 listed)
- Metastatic disease (Stage IV) ;
- Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
- Progressive disease during neoadjuvant therapy;
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
- Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
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 |
|---|---|---|
| pyrotinibpyrotinib 400 mg, orally once daily for one year | Drug | Pyrotinib |
Primary outcome
Invasive Disease-free Survival (iDFS)
Time frame: From randomization until time of event up to 2 years.
Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
2 secondary outcomes
Disease-free Survival (DFS)
Time frame: From randomization until time of event up to 2 years
Overall Survival (OS)
Time frame: From randomization until time of event up to 2 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 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jinsong Lu principal investigator
RenJi Hospital
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 pyrotinib in people with Locally Advanced Breast Cancer, run by RenJi 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 10 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 11 Sep 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 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 Wenjin Yin (86(21)68385569, followroad@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease-free Survival (iDFS) (time frame: From randomization until time of event up to 2 years.). 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 11 Sep 2025.