HER2-positive Breast CancerNeraHER2NCT06693024
Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
An observational study of HER2-positive Breast Cancer, run by Shu Wang at 1 site in China.
Trial summary
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- neratinib
- How many people
- 2,806 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Early stage HER2 positive breast cancer patients received radical surgery and standard neoadjuvant/adjuvant therapy
Who may be able to join
- 1) Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
- 2) The patients were treated in our hospital and underwent radical resection with hospitalization records;
- 3) Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
- 4) Has signed and agreed to participate in the PKUPH breast disease cohort study.
Who cannot join
- 1) Lack of clinical and pathological data (such as imaging data and pathological data);
- 2) Patients with metastatic breast cancer or bilateral breast cancer;
- 3) Failure to perform radical surgery
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
yuan peng, Dr
About this study
Official title: A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. In addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (TKI) can further improve the survival. The evidence of previous adjuvant TKI anti-HER2 therapy was mainly from ExteNET study. However, due to the limitations of the times, ExteNET research is based on the background of only trastuzumab targeted therapy. Nowadays, there is no evidence that trastuzumab combined patuzumab,use of T-DM1, followed by sequential neratinib can still obtain absolute benefits. Therefore, there is no standard for the use of neratinib in current clinical practice. Investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.
Read the detailed description
Investigators retrospectively recuited patients with early HER2 positive breast cancer treated in Peking University People's Hospital center from January 1, 2019 to November 31, 2024, and prospectively recruit same patients from December 1, 2024 to December 31, 2028. To compare the efficacy and safety of sequential use of neratinib.
Inclusion Criteria:
- Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
- The patients were treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
- Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
- Has signed and agreed to participate in the PKUPH breast disease cohort study.
Exclusion Criteria:
- Lack of clinical and pathological data (such as imaging data and pathological data);
- Patients with metastatic breast cancer or bilateral breast cancer;
- Failure to perform radical surgery patients recieved Neratinib for 1 year or not.
Primary end point: 5-year invasive dieased free survival
- Conditions
- HER2-positive Breast Cancer
- Being tested
- neratinib
- Keywords
- adjuvant therapy, neratinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neratinibDrug
neratinib 240mg qd for 1 year
| Study group | Role | What they receive |
|---|---|---|
| neratinib | After standard anti-HER2 neoadjuvant/adjuvant therapy, sequential targeted therapy with neratinib for 1 year Receives: Drug: neratinib | |
| control group | After standard anti-HER2 neoadjuvant/adjuvant therapy, no sequential targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive disease free survival
The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.
Measured: 5 years
Secondary outcomes (4)
disease free survival
The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.
Measured: 5 years
distant disease free survival
Time from study enrollment to distant recurrence and metastasis
Measured: 5 years
breast cancer specific survival
Time from study enrollment to death due to breast cancer
Measured: 5 years
overall survival
Time from study enrollment to death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,806 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu Wang, Peking University People's Hospital
- Investigators
- shu wang, doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693024
- Sponsor's protocol ID
- PKUPH2024Z168
- Acronym
- NeraHER2
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06693024
- Acronym / sponsor ID
- NeraHER2 / PKUPH2024Z168
- Conditions
- HER2-positive Breast Cancer
- Keywords
- adjuvant therapy, neratinib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,806 participants (estimated)
- Lead sponsor
- Shu WangUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 18 Nov 2024 (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.
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. In addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (TKI) can further improve the survival. The evidence of previous adjuvant TKI anti-HER2 therapy was mainly from ExteNET study. However, due to the limitations of the times, ExteNET research is based on the background of only trastuzumab targeted therapy. Nowadays, there is no evidence that trastuzumab combined patuzumab,use of T-DM1, followed by sequential neratinib can still obtain absolute benefits. Therefore, there is no standard for the use of neratinib in current clinical practice. Investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.
Detailed description
Investigators retrospectively recuited patients with early HER2 positive breast cancer treated in Peking University People's Hospital center from January 1, 2019 to November 31, 2024, and prospectively recruit same patients from December 1, 2024 to December 31, 2028. To compare the efficacy and safety of sequential use of neratinib.
Inclusion Criteria:
- Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
- The patients were treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
- Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
- Has signed and agreed to participate in the PKUPH breast disease cohort study.
Exclusion Criteria:
- Lack of clinical and pathological data (such as imaging data and pathological data);
- Patients with metastatic breast cancer or bilateral breast cancer;
- Failure to perform radical surgery patients recieved Neratinib for 1 year or not.
Primary end point: 5-year invasive dieased free survival
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neratinib | – | Drug: neratinibAfter standard anti-HER2 neoadjuvant/adjuvant therapy, sequential targeted therapy with neratinib for 1 year |
| control group | – | –After standard anti-HER2 neoadjuvant/adjuvant therapy, no sequential targeted therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Early stage HER2 positive breast cancer patients received radical surgery and standard neoadjuvant/adjuvant therapy
Key inclusion criteria (4 listed)
- 1) Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
- 2) The patients were treated in our hospital and underwent radical resection with hospitalization records;
- 3) Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
- 4) Has signed and agreed to participate in the PKUPH breast disease cohort study.
Key exclusion criteria (3 listed)
- 1) Lack of clinical and pathological data (such as imaging data and pathological data);
- 2) Patients with metastatic breast cancer or bilateral breast cancer;
- 3) Failure to perform radical surgery
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 |
|---|---|---|
| neratinibneratinib 240mg qd for 1 year | Drug | neratinib |
Primary outcome
invasive disease free survival
Time frame: 5 years
The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.
4 secondary outcomes
disease free survival
Time frame: 5 years
distant disease free survival
Time frame: 5 years
breast cancer specific survival
Time frame: 5 years
overall survival
Time frame: 5 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 20 Nov 2024.
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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.
shu wang, doctor principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by Shu Wang 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 4 inclusion and 3 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 20 Nov 2024. 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.
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 yuan peng, doctor (86+13671287670, 13671287670@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 (time frame: 5 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 20 Nov 2024.