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

NCT07636096 | Completed

• 1 other identifier: SYSEC2-2026-BA-790
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Phyllodes Breast Tumor; Prognosis

Outcome Measures

Primary Outcomes (3)

• Local Recurrence, LR

  Recurrence 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

  3 year

• Overall Survival, OS

  Overall 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

  3 year

• Distant Metastasis, DM

  Extramammary 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

  3 year

Study Arms (3)

Benign Phyllodes Tumor

Borderline Phyllodes Tumor

Malignant Phyllodes Tumor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes patients who underwent surgical resection for breast phyllodes tumor (PT) at one of eight tertiary hospitals in China between January 1, 2001, and December 31, 2023. All patients with a postoperative paraffin-embedded pathology diagnosis of benign, borderline, or malignant PT according to WHO criteria are included. Exclusion criteria are: (1) PT with uncertain behavior or unclassified grade; (2) history of prior malignancy (excluding breast cancer) with less than 5 years disease-free survival, or concurrent diseases that may affect endpoint assessment; (3) loss to follow-up or missing critical data (pathological grade, surgical procedure, or follow-outcome). A total of approximately 3,500 eligible patients from eight participating centers will be enrolled. All patients are of Chinese ethnicity.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (8)

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• Ostrauskas R, Zalinkevicius R, Jurgeviciene N, Radzeviciene L, Lasaite L. The incidence of type 1 diabetes mellitus among 15-34 years aged Lithuanian population: 18-year incidence study based on prospective databases. BMC Public Health. 2011 Oct 19;11:813. doi: 10.1186/1471-2458-11-813.

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• Maeshima A, Zhang YQ, Furukawa M, Naruse T, Kojima I. Hepatocyte growth factor induces branching tubulogenesis in MDCK cells by modulating the activin-follistatin system. Kidney Int. 2000 Oct;58(4):1511-22. doi: 10.1046/j.1523-1755.2000.00313.x.

  PMID: 11012886 BACKGROUND

• Zhang Y, Kleer CG. Phyllodes Tumor of the Breast: Histopathologic Features, Differential Diagnosis, and Molecular/Genetic Updates. Arch Pathol Lab Med. 2016 Jul;140(7):665-71. doi: 10.5858/arpa.2016-0042-RA.

  PMID: 27362571 BACKGROUND

• Miller AR, Wijeratne S, McGrath SD, Schieffer KM, Miller KE, Lee K, Mathew M, LaHaye S, Fitch JR, Kelly BJ, White P, Mardis ER, Wilson RK, Cottrell CE, Magrini V. Pacific Biosciences Fusion and Long Isoform Pipeline for Cancer Transcriptome-Based Resolution of Isoform Complexity. J Mol Diagn. 2022 Dec;24(12):1292-1306. doi: 10.1016/j.jmoldx.2022.09.003. Epub 2022 Sep 30.

  PMID: 36191838 BACKGROUND

MeSH Terms

Conditions

Phyllodes Tumor

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 9, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 20, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

CN (1)