NCT06693024 Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
| NCT ID | NCT06693024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shu Wang |
| Condition | HER2-positive Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,806 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,806 participants in total. It began in 2019-01-01 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
shu wang, doctor
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06693024 clinical trial?
This trial is open to participants of all sexes, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06693024 currently recruiting?
Yes, NCT06693024 is actively recruiting participants. Contact the research team at 13671287670@163.com for enrollment information.
Where is the NCT06693024 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06693024 clinical trial?
NCT06693024 is sponsored by Shu Wang. The principal investigator is shu wang, doctor at Peking University People's Hospital. The trial plans to enroll 2,806 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.