Phyllodes Breast TumorNCT07636096
Breast Phyllodes Tumors: Based on 20-year Real-world Data From China
An observational study of Phyllodes Breast Tumor and Prognosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Phyllodes Breast Tumor, Prognosis
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 20 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Clinical Features, Treatment Patterns, and Prognosis of Breast Phyllodes Tumors: A Multicenter Retrospective Study Based on 20-year Real-world Data From China.
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.
Read more
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
- Medical subject headings
- Phyllodes Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign Phyllodes Tumor | Not described | |
| Borderline Phyllodes Tumor | Not described | |
| Malignant Phyllodes Tumor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 May 2026
- Primary completion1 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Phyllodes Breast TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, The First Affiliated Hospital of Guangzhou Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Peking University Shenzhen Hospital, Foshan Women's and Children's Hospital
- Responsible party
- Principal investigator, Yan Nie, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636096
- Sponsor's protocol ID
- SYSEC2-2026-BA-790
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Varghese S, Seldon Y, Raperport C, Rinne N, Patel K, Zaid RZ. Isolated fallopian tube torsion: A systematic review of case reports. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:140-147. doi: 10.1016/j.ejogrb.2024.02.050. Epub 2024 Feb 29.
PubMed 38432020Takeda I, Yamada A, Onodera H. Artificial Intelligence-Assisted motion capture for medical applications: a comparative study between markerless and passive marker motion capture. Comput Methods Biomech Biomed Engin. 2021 Jun;24(8):864-873. doi: 10.1080/10255842.2020.1856372. Epub 2020 Dec 8.
PubMed 33290107Jansaka N, Suprasert P. Survival outcomes of recurrent epithelial ovarian cancer: experience from a Thailand northern tertiary care center. Asian Pac J Cancer Prev. 2014;15(24):10837-40. doi: 10.7314/apjcp.2014.15.24.10837.
PubMed 25605186Ostrauskas 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.
PubMed 22011463Gupta PJ. Randomized controlled study: radiofrequency coagulation and plication versus ligation and excision technique for rectal mucosal prolapse. Am J Surg. 2006 Aug;192(2):155-60. doi: 10.1016/j.amjsurg.2006.03.012.
PubMed 16860622Maeshima 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.
PubMed 11012886Zhang 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.
PubMed 27362571Miller 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.
PubMed 36191838
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features, Treatment Patterns, and Prognosis of Breast Phyllodes Tumors: A Multicenter Retrospective Study Based on 20-year Real-world Data From China.
- ClinicalTrials.gov ID
- NCT07636096
- Acronym / sponsor ID
- SYSEC2-2026-BA-790
- Conditions
- Phyllodes Breast Tumor, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, The First Affiliated Hospital of Guangzhou Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Peking University Shenzhen Hospital, Foshan Women's and Children's Hospital
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benign Phyllodes Tumor | – | – |
| Borderline Phyllodes Tumor | – | – |
| Malignant Phyllodes Tumor | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local Recurrence, LR
Time frame: 3 year
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
Overall Survival, OS
Time frame: 3 year
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
Distant Metastasis, DM
Time frame: 3 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 38432020Varghese S, Seldon Y, Raperport C, Rinne N, Patel K, Zaid RZ. Isolated fallopian tube torsion: A systematic review of case reports. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:140-147. doi: 10.1016/j.ejogrb.2024.02.050. Epub 2024 Feb 29.
- Background: PubMed 33290107Takeda I, Yamada A, Onodera H. Artificial Intelligence-Assisted motion capture for medical applications: a comparative study between markerless and passive marker motion capture. Comput Methods Biomech Biomed Engin. 2021 Jun;24(8):864-873. doi: 10.1080/10255842.2020.1856372. Epub 2020 Dec 8.
- Background: PubMed 25605186Jansaka N, Suprasert P. Survival outcomes of recurrent epithelial ovarian cancer: experience from a Thailand northern tertiary care center. Asian Pac J Cancer Prev. 2014;15(24):10837-40. doi: 10.7314/apjcp.2014.15.24.10837.
- Background: PubMed 22011463Ostrauskas 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.
- Background: PubMed 16860622Gupta PJ. Randomized controlled study: radiofrequency coagulation and plication versus ligation and excision technique for rectal mucosal prolapse. Am J Surg. 2006 Aug;192(2):155-60. doi: 10.1016/j.amjsurg.2006.03.012.
- Background: PubMed 11012886Maeshima 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.
- Background: PubMed 27362571Zhang 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.
- Background: PubMed 36191838Miller 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phyllodes Breast Tumor and Prognosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Recurrence, LR (time frame: 3 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07636096, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.