Choosing adjuvant therapy for HER2 positive early breast cancer after initial treatment
Official title: A Cohort Study of Different Choice of Adjuvant Therapy in Non-PCR Patients With HER2 Positive Early Breast Cancer After Neoadjuvant Therapy
Run by Peking University People's Hospital · NCT06693037 · Data updated 2026-11-12
This study is testing whether a combination of trastuzumab and pertuzumab works better than T-DM1 for people with HER2 positive breast cancer who still have cancer after their initial treatment.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 2092 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy, patuzumab |
| 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 | November 20, 2024 |
| Trial ID | NCT06693037 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with HER2 positive breast cancer who have undergone neoadjuvant therapy and have residual invasive cancer post-surgery.
✕Probably not a fit
Patients with metastatic breast cancer, bilateral breast cancer, or those who did not undergo radical surgery may 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 focuses on patients with HER2 positive breast cancer who have undergone neoadjuvant therapy with trastuzumab and pertuzumab but still have residual invasive cancer post-surgery. It aims to evaluate the effectiveness of different adjuvant therapies, specifically comparing a combination of trastuzumab and pertuzumab versus T-DM1. The study will retrospectively recruit patients treated between January 2019 and November 2024 and prospectively recruit from December 2024 to December 2028. The goal is to improve prognosis and survival rates for this specific patient population.
Why it matters
Potential benefit: If successful, this study could lead to more effective adjuvant therapy options for patients with residual HER2 positive breast cancer, potentially improving their survival rates.
How similar studies have gone: Previous studies have shown varying success with adjuvant therapies for HER2 positive breast cancer, but this specific approach is novel and aims to address gaps in current treatment guidelines.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital; * 2\) The clinical stages before treatment were T1-T4, N0-N3, M0; * 3\) Received treatment and operation in our hospital, and had hospitalization records; * 4\) Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy * 5\) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes; * 6\) 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; * 4\) Receiving other regimens besides the established neoadjuvant regimens.
Where it's running
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Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: shu wang, doctor — Peking University People's Hospital
- 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.