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Breast Phyllodes Tumors: Based on 20-year Real-world Data From China

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07636096
Enrollment
3500
Registered
2026-06-09
Start date
2026-05-01
Completion date
2026-05-20
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phyllodes Breast Tumor, Prognosis

Brief 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.

Interventions

None listed

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER
Sun Yat-Sen University Cancer Center
CollaboratorOTHER
The First Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
First People's Hospital of Foshan
CollaboratorOTHER
Zhongshan People's Hospital, Guangdong, China
CollaboratorOTHER
Peking University Shenzhen Hospital
CollaboratorOTHER
Foshan Women's and Children's Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Breast phyllodes tumors (benign, borderline, or malignant) based on postoperative paraffin pathology according to WHO criteria * Underwent surgical treatment * Complete or substantially complete clinical records, pathology reports, and follow-up data

Exclusion criteria

* Phyllodes without histological grading * Hstory of other concomitant diseases that may affect the assessment of the study endpoint events * Patients lost to follow-up or with missing key data

Design outcomes

Primary

MeasureTime frameDescription
Local Recurrence, LR3 yearRecurrence was defined as pathologically confirmed reoccurrence of phyllodes tumor in the ipsilateral breast, chest wall, or axillary lymph nodes after initial surgery, based on postoperative follow-up records (including outpatient visits, hospitalizations, and imaging findings) and pathology reports
Overall Survival, OS3 yearOverall survival was defined as the time interval from the date of initial surgery to the date of death from any cause, measured in months. Patients who remained alive were censored at the date of their last follow-up
Distant Metastasis, DM3 yearExtramammary organ metastasis (including but not limited to the lungs, liver, bones, and brain) confirmed by imaging studies (CT, PET-CT, bone scan, etc.) and/or pathological examination

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026