Breast Cancer InvasivePhase 3CORINNE-PINCT05910398
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
A Phase 3 study testing pyrotinib in people with Breast Cancer Invasive, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Invasive
- 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
- 488 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Aug 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18;
- Histologically confirmed invasive HER2 positive breast cancer;
- Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Adequate organ functions.
Who cannot join
- Metastatic disease (Stage IV);
- Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
- Treated or treating with anti-HER2 tyrosine kinase inhibitor;
- Less than 4 weeks from the last clinical trial;
- History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
- 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 Jiaotong University
Shanghai, 200127
Wenjin Yin, 86(21)68385569, yinwenjin@renji.com
About this study
Official title: Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
- Conditions
- Breast Cancer Invasive
- Being tested
- pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinibDrug
an irreversible anti-HER2 tyrosine kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| continuous pyrotinib | Active comparator | pyrotinib 400 mg, orally once daily for one year Receives: Drug: pyrotinib |
| intermittent pyrotinib | Experimental | pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles Receives: Drug: pyrotinib |
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 (3)
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
Adverse events
Adverse events will be assessed according to the NCI CTCAE v5.0.
Measured: From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jun 2023
- Primary completionApr 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Wenjin Yin, M.D., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910398
- Sponsor's protocol ID
- LY2023-063-A
- Acronym
- CORINNE-PI
- Status last verified
- Nov 2025
- First submitted
- 9 Jun 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT05910398
- Acronym / sponsor ID
- CORINNE-PI / LY2023-063-A
- Conditions
- Breast Cancer Invasive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 18 Jun 2023 (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, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous pyrotinib | Active comparator | Drug: pyrotinibpyrotinib 400 mg, orally once daily for one year |
| intermittent pyrotinib | Experimental | Drug: pyrotinibpyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18;
- Histologically confirmed invasive HER2 positive breast cancer;
- Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Adequate organ functions.
Key exclusion criteria (8 listed)
- Metastatic disease (Stage IV);
- Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
- Treated or treating with anti-HER2 tyrosine kinase inhibitor;
- Less than 4 weeks from the last clinical trial;
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 |
|---|---|---|
| pyrotiniban irreversible anti-HER2 tyrosine kinase inhibitor | Drug | continuous pyrotinib, intermittent 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.
3 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
Adverse events
Time frame: From the date of starting pyrotinib to the end of the treatment (up to approximately 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 18 Nov 2025.
- 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.
Wenjin Yin, M.D. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
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 Breast Cancer Invasive, 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 5 inclusion and 8 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 Nov 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, M.D. (86(21)58852345, yinwenjin@renji.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 18 Nov 2025.