HER2-positive Breast CancerPhase 2NCT05834764
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
A Phase 2 study testing Pyrotinib in people with HER2-positive Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. 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
- 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
- 188 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2023to 31 Dec 2028
- 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
- Subjects voluntarily participate in this study and sign the informed consent form；
- Female or male patients, aged ≥ 18 years, and ≤75 years;
- ECOG PS score: 0-1;
- Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
- Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
- Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
- Could have been treated neoadjuvantly but have not reached pathologic complete response.
Who cannot join
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom.
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
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Xiaoan Liu, Professor, 025-68308162, liuxiaoan@126.com
About this study
Official title: Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.
However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.
- Conditions
- HER2-positive 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
Also called Pyrotinib maleate
Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib | Experimental | pyrotinib 400mg orally daily for one year 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) at year 2
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
Measured: From enrollment until time of events up to 2 years
Secondary outcomes (4)
Disease-free Survival at year 2 (2y-DFS)
Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.
Measured: From enrollment until time of events up to 2 years
Overall Survival (OS)
Randomization to death from any cause
Measured: Enrollment until death due to any cause, up to 10 years
Invasive Disease-free Survival (iDFS) at year 5
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
Measured: From enrollment until time of events up to 5 years
AEs and SAEs
Adverse events and Adverse events and serious adverse events according to CACTE 5.0
Measured: From the first administration to one months after the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start8 Apr 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2028 (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 The First Affiliated Hospital with Nanjing Medical 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
- 188 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Liu Xiaoan, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiaoan Liu, Professor, Principal investigator, Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834764
- Sponsor's protocol ID
- OBU-BC-II-083
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05834764
- Acronym / sponsor ID
- OBU-BC-II-083
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 8 Apr 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Apr 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.
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.
However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib | Experimental | Drug: Pyrotinibpyrotinib 400mg orally daily for one year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects voluntarily participate in this study and sign the informed consent form；
- Female or male patients, aged ≥ 18 years, and ≤75 years;
- ECOG PS score: 0-1;
- Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
- Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
Key exclusion criteria (6 listed)
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
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 |
|---|---|---|
| PyrotinibAlso: Pyrotinib maleatePyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1） | Drug | Pyrotinib |
Primary outcome
Invasive Disease-free Survival (iDFS) at year 2
Time frame: From enrollment until time of events up to 2 years
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
4 secondary outcomes
Disease-free Survival at year 2 (2y-DFS)
Time frame: From enrollment until time of events up to 2 years
Overall Survival (OS)
Time frame: Enrollment until death due to any cause, up to 10 years
Invasive Disease-free Survival (iDFS) at year 5
Time frame: From enrollment until time of events up to 5 years
AEs and SAEs
Time frame: From the first administration to one months after the last drug administration
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 28 Apr 2023.
- 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.
Xiaoan Liu, Professor principal investigator
Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
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 in people with HER2-positive Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 7 inclusion and 6 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 28 Apr 2023. 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 Xiaoan Liu, Professor (025-68308162, liuxiaoan@126.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) at year 2 (time frame: From enrollment until time of events 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 28 Apr 2023.