Evaluating amlotinib for advanced HER2-negative breast cancer
A Real-world Study of the Efficacy and Safety of Amlotinib for the Treatment of HER2-negative Advanced Breast Cancer
This study is testing if the drug amlotinib can help people with advanced HER2-negative breast cancer live longer and feel better, whether used alone or with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 153 (estimated) |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | amlotinib, anilotinib |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06340165 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the real-world efficacy and safety of amlotinib in patients with HER2-negative advanced breast cancer. It examines various treatment lines, including monotherapy and combination therapy, while considering different molecular subtypes of breast cancer. The study involves regular imaging and efficacy assessments based on established criteria, with a focus on progression-free survival and overall survival. Data will be analyzed using statistical methods to provide evidence for the use of amlotinib in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent or metastatic HER2-negative breast cancer who have completed at least two cycles of amlotinib treatment.
Not a fit: Patients with symptomatic brain metastases or those receiving local treatments like surgery or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable evidence for the use of amlotinib as a treatment option for patients with advanced HER2-negative breast cancer.
How similar studies have performed: While the use of amlotinib in breast cancer is considered a supra-indication, this study aims to provide new evidence, as similar approaches have not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Imaging or tissue/cell puncture, etc. confirmed recurrent, metastatic breast cancer * Pathologically confirmed HER-2 negative * Application of amlotinib treatment until disease progression or toxicity intolerable, or voluntarily give up the continuation of amlotinib treatment,amlotinib application for at least 2 cycles * The clinical data are basically complete Exclusion criteria: * Patients receiving local treatment means such as surgery and radiotherapy * Patients with combined second primary breast cancer and other primary malignant tumors * Patients with symptomatic brain metastases
Where this trial is running
Changchun, Jilin
- The First Affiliated Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Jiuwei Cui
- Email: jdyycjw@163.com
- Phone: 15843073215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.