CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,500 enrolled / 3,500 target
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT07636096
NCT07636096N/ACompletedHigh Momentum (1715.0/mo)Completion was 2mo ago

Clinical Features, Treatment Patterns, and Prognosis of Breast Phyllodes Tumors: A Multicenter Retrospective Study Based on 20-year Real-world Data From China.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University·observational·Posted Jun 9, 2026·Updated Jun 9, 2026

In Brief

An observational study for Phyllodes Breast Tumor and Prognosis. Completed, enrolled 3,500 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

Phyllodes tumor (PT) is a rare type of breast tumor made up of both connective tissue (stroma) and gland tissue (epithelium). It accounts for less than 1% of all breast tumors. The main symptom is a fast-growing, painless lump. Based on its appearance under a microscope, the World Health Organization (WHO) classifies PT into three grades: benign (non-cancerous), borderline (intermediate), and malignant (cancerous). The chance of the tumor coming back after treatment (recurrence) is about 7%, 17%, and 25% for each grade, respectively. The average age when patients are diagnosed is between 36 and 55 years, and the typical tumor size ranges from about 4 to 11 cm. Malignant PT can spread to other parts of the body (metastasis) in up to 6% to 62% of cases, most often to the lungs or bones through the bloodstream. Because PT is rare, large studies on its causes, diagnosis, treatment, and long-term outlook are very limited. PT can grow very quickly. Delaying diagnosis and treatment may allow the tumor to become so large that surgery is no longer an option. Standard imaging tests (ultrasound, mammogram, MRI) have limited ability to tell the difference between benign and malignant PT. Also, since these tumors are often large and vary from one area to another, a small needle biopsy may not show the whole picture. An accurate grade is usually only possible after the whole tumor is removed and examined by a pathologist. PT does not respond well to radiation or chemotherapy. Therefore, the main treatment is complete surgical removal with clear margins. The role of newer therapies such as targeted therapy or immunotherapy is still being studied. Although the WHO grade gives some idea of how the patient might do, some benign PT can come back many times or even turn malignant, while some malignant PT stay stable for a long time. The current grading system does not fully explain why individual outcomes differ. In recent years, most prediction models for PT have been built using Western patient data (for example, from the SEER database). These models have not been tested in Asian populations. They are usually based on small, single-center studies with dozens to a few hundred patients, and many have only been checked inside the same database without outside (external) validation. Most studies focus on symptoms, imaging findings, how to tell benign from malignant PT, or comparing different types of surgery. Few have looked closely at patterns of recurrence and metastasis, or risk factors for rare events like multiple recurrences, distant spread, or death. To fill these gaps, we plan to conduct a large, multi-center, retrospective (looking back at past medical records) study across 8 top hospitals in China. We will use real-world data from about 3,500 patients with breast PT diagnosed between 2001 and 2023. The main goals are to describe the clinical and pathological features, treatment patterns, and long-term outcomes of Chinese PT patients. The main outcomes we will measure are local recurrence, distant metastasis, and overall survival. Secondary outcomes include disease characteristics and current treatment practices. This study aims to provide evidence from the Chinese population to help guide personalized treatment and future updates to clinical guidelines.

Study Details

Timeline

N/ACompletedFinished
First PostedJun 9, 2026
Enrollment StartMay 1, 2026
Primary CompletionMay 1, 2026
Study CompletionMay 20, 2026
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 23 days ago

Arms & Interventions

Benign Phyllodes Tumorother

Borderline Phyllodes Tumorother

Malignant Phyllodes Tumorother