Combining chemotherapy and targeted therapy for early HER2 positive breast cancer
Official title: Cohort Study of Chemotherapy Combined With Targeted Adjuvant Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
Run by Peking University People's Hospital · NCT06722612 · Data updated 2026-11-12
This study is testing if combining chemotherapy with targeted therapy can help people with early HER2 positive breast cancer feel better while using less chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 2916 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | December 31, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | December 9, 2024 |
| Trial ID | NCT06722612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with T2, N0, HER2 positive early breast cancer who have undergone radical surgery and have high-risk pathological features.
✕Probably not a fit
Patients with metastatic breast cancer, bilateral breast cancer, or those who have not undergone radical surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness and safety of combining chemotherapy with targeted therapy for patients with high-risk HER2 positive early breast cancer who have negative lymph nodes. The aim is to explore whether reducing chemotherapy while incorporating targeted treatments can maintain efficacy and minimize toxicity. The study focuses on patients who have undergone radical resection and have specific pathological characteristics indicating high risk. By stratifying patients based on risk factors, the research seeks to optimize treatment strategies for this subgroup.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and less toxic treatment options for patients with early HER2 positive breast cancer.
How similar studies have gone: While the approach of combining targeted therapy with chemotherapy is established, this specific strategy for high-risk, lymph node negative patients is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records; * 2\) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative); * 3\) 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\) Preoperative neoadjuvant therapy; * 3\) Patients with metastatic breast cancer or bilateral breast cancer; * 4\) Failure to perform radical surgery.
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: yuan peng, doctor
- Email: 13671287670@163.com
- Phone: 86+13671287670
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.