Radiotherapy, AdjuvantNCT06780059
Effects of Radiotherapy in Borderline and Malignant Phyllodes Tumors After R0 Resection
An observational study of Radiotherapy, Adjuvant and Phyllodes Breast Tumor, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
Trial summary
Breast phyllodes tumors (PT) are rare fibroepithelial neoplasms originating from stromal tissue and account for less than 1% of all breast tumors. The World Health Organization (WHO) classifies PT into benign, borderline, and malignant subtypes based on pathological features such as mitotic activity, cellular atypia… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Radiotherapy, Adjuvant, Phyllodes Breast Tumor, Prognosis
- What is being tested?
- Adjuvant Radiotherapy and R0 resection
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 3 sitesChina
- Study dates
- 30 Dec 2024to 2 Jan 2025
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients pathologically diagnosed with BoPT and MPT who underwent surgery at three medical institutions in China: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Sun Yat-sen University Cancer Center, and the Third Affiliated Hospital of Nanchang University.
Who may be able to join
- patients who were initially diagnosed with BoPT or MPT and underwent R0 resection surgery
Who cannot join
- patients who had their initial surgery at other hospitals without accurate baseline data
- patients who received radiotherapy before surgery
- those presenting with initial distant metastasis before treatment
- patients lost to follow-up after treatment
- patients with a history of or concurrent breast cancer or precancerous lesions in the ipsilateral breast or with breast cancer in the contralateral breast
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510050
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Third Hospital of Nanchang
Nanchang, Jiangxi
About this study
Official title: Effects of Radiotherapy on Recurrence and Survival in Borderline and Malignant Phyllodes Tumors After R0 Resection: a Propensity Score Analysis
Breast phyllodes tumors (PT) are rare fibroepithelial neoplasms originating from stromal tissue and account for less than 1% of all breast tumors. The World Health Organization (WHO) classifies PT into benign, borderline, and malignant subtypes based on pathological features such as mitotic activity, cellular atypia, tumor margin invasion, and stromal composition 1. The presence of malignant heterologous elements characterizes the tumor as malignant 2. Surgery is the primary treatment. However, even after R0 resection, borderline phyllodes tumors (BoPT) and malignant phyllodes tumors (MPT) patients remain face a high risk of local recurrence, with rates of 15%-20% and 25%-30%, respectively. Moreover, metastases occur almost merely in MPT, with a distant metastasis rate reaching 22%.
Adjuvant radiotherapy has attracted attention for its potential to improve local control and reduce recurrence, but the role after R0 resection in PT patients remains unclear. Radiotherapy significantly reduces local recurrence rates in BoPT and MPT but shows no substantial benefit in benign cases. However, a meta-analysis by Yu et al. found that this effect is limited to MPT. Additionally, the effect of radiotherapy on survival rates in PT remains controversial. Most existing studies are retrospective and face limitations such as small sample sizes. The rarity of PT and conflicting evidence of impact of radiotherapy necessitate further study. While prospective trials are difficult due to limited cases, well-designed retrospective studies can offer valuable insights. In this study, the investigators also analyzed prognostic factors and identified subgroups to provide a clinical reference for the application of postoperative radiotherapy in BoPT and MPT patients.
- Conditions
- Radiotherapy, Adjuvant, Phyllodes Breast Tumor, Prognosis
- Being tested
- Adjuvant Radiotherapy, R0 resection
- Medical subject headings
- Phyllodes Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant RadiotherapyRadiation
Postoperative Radiotherapy with 3D-CRT and IMRT Techniques Following R0 Resection in BoPT and MPT Patients
R0 resectionProcedure or surgery
Patients who received R0 resection (complete resection without tumor margin)
| Study group | Role | What they receive |
|---|---|---|
| Phyllodes tumors patients who received radiotherapy afte R0 resection | Not described Receives: Radiation: Adjuvant Radiotherapy; Procedure: R0 resection | |
| Phyllodes tumors patients who received R0 resection alone | Not described Receives: Procedure: R0 resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Local Recurrence-free Survival
The time period from the initial R0 resection to either the detection of local recurrence or the final follow-up.
Measured: Five years
Secondary outcomes (1)
5-year Overall Survival
The time from the first R0 resection to either all-cause mortality or the last follow-up.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start30 Dec 2024
- Primary completion2 Jan 2025
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy, AdjuvantStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- 480 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Nie, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780059
- Sponsor's protocol ID
- SYSKY-2024-1127-01
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to make individual participant data available to other researchers.
Publications
Macdonald OK, Lee CM, Tward JD, Chappel CD, Gaffney DK. Malignant phyllodes tumor of the female breast: association of primary therapy with cause-specific survival from the Surveillance, Epidemiology, and End Results (SEER) program. Cancer. 2006 Nov 1;107(9):2127-33. doi: 10.1002/cncr.22228.
PubMed 16998937Pandey M, Mathew A, Kattoor J, Abraham EK, Mathew BS, Rajan B, Nair KM. Malignant phyllodes tumor. Breast J. 2001 Nov-Dec;7(6):411-6. doi: 10.1046/j.1524-4741.2001.07606.x.
PubMed 11843853Boutrus RR, Khair S, Abdelazim Y, Nasr S, Ibraheem MH, Farahat A, El Sebaie M. Phyllodes tumors of the breast: Adjuvant radiation therapy revisited. Breast. 2021 Aug;58:1-5. doi: 10.1016/j.breast.2021.03.013. Epub 2021 Apr 7.
PubMed 33865208Yu CY, Huang TW, Tam KW. Management of phyllodes tumor: A systematic review and meta-analysis of real-world evidence. Int J Surg. 2022 Nov;107:106969. doi: 10.1016/j.ijsu.2022.106969. Epub 2022 Oct 31.
PubMed 36328344Li J, Tsang JY, Chen C, Chan SK, Cheung SY, Wu C, Kwong A, Hu J, Hu H, Zhou D, Tse GM. Predicting Outcome in Mammary Phyllodes Tumors: Relevance of Clinicopathological Features. Ann Surg Oncol. 2019 Sep;26(9):2747-2758. doi: 10.1245/s10434-019-07445-1. Epub 2019 May 20.
PubMed 31111353Belkacemi Y, Bousquet G, Marsiglia H, Ray-Coquard I, Magne N, Malard Y, Lacroix M, Gutierrez C, Senkus E, Christie D, Drumea K, Lagneau E, Kadish SP, Scandolaro L, Azria D, Ozsahin M. Phyllodes tumor of the breast. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):492-500. doi: 10.1016/j.ijrobp.2007.06.059. Epub 2007 Oct 10.
PubMed 17931796Pezner RD, Schultheiss TE, Paz IB. Malignant phyllodes tumor of the breast: local control rates with surgery alone. Int J Radiat Oncol Biol Phys. 2008 Jul 1;71(3):710-3. doi: 10.1016/j.ijrobp.2007.10.051. Epub 2008 Jan 30.
PubMed 18234448Moffat CJ, Pinder SE, Dixon AR, Elston CW, Blamey RW, Ellis IO. Phyllodes tumours of the breast: a clinicopathological review of thirty-two cases. Histopathology. 1995 Sep;27(3):205-18. doi: 10.1111/j.1365-2559.1995.tb00212.x.
PubMed 8522284Md Nasir ND, Koh VCY, Cree IA, Ruiz BII, Del Aguila J, Armon S, Fox SB, Lakhani SR, Tan PH. Phyllodes tumour evidence gaps mapped from the 5th edition of the WHO classification of tumours of the breast. Histopathology. 2023 Apr;82(5):704-712. doi: 10.1111/his.14856. Epub 2023 Jan 30.
PubMed 36579383
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Radiotherapy on Recurrence and Survival in Borderline and Malignant Phyllodes Tumors After R0 Resection: a Propensity Score Analysis
- ClinicalTrials.gov ID
- NCT06780059
- Acronym / sponsor ID
- SYSKY-2024-1127-01
- Conditions
- Radiotherapy, Adjuvant, Phyllodes Breast Tumor, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 17 Jan 2025 (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.
Breast phyllodes tumors (PT) are rare fibroepithelial neoplasms originating from stromal tissue and account for less than 1% of all breast tumors. The World Health Organization (WHO) classifies PT into benign, borderline, and malignant subtypes based on pathological features such as mitotic activity, cellular atypia, tumor margin invasion, and stromal composition 1. The presence of malignant heterologous elements characterizes the tumor as malignant 2. Surgery is the primary treatment. However, even after R0 resection, borderline phyllodes tumors (BoPT) and malignant phyllodes tumors (MPT) patients remain face a high risk of local recurrence, with rates of 15%-20% and 25%-30%, respectively. Moreover, metastases occur almost merely in MPT, with a distant metastasis rate reaching 22%.
Adjuvant radiotherapy has attracted attention for its potential to improve local control and reduce recurrence, but the role after R0 resection in PT patients remains unclear. Radiotherapy significantly reduces local recurrence rates in BoPT and MPT but shows no substantial benefit in benign cases. However, a meta-analysis by Yu et al. found that this effect is limited to MPT. Additionally, the effect of radiotherapy on survival rates in PT remains controversial. Most existing studies are retrospective and face limitations such as small sample sizes. The rarity of PT and conflicting evidence of impact of radiotherapy necessitate further study. While prospective trials are difficult due to limited cases, well-designed retrospective studies can offer valuable insights. In this study, the investigators also analyzed prognostic factors and identified subgroups to provide a clinical reference for the application of postoperative radiotherapy in BoPT and MPT patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phyllodes tumors patients who received radiotherapy afte R0 resection | – | Radiation: Adjuvant Radiotherapy, Procedure: R0 resection |
| Phyllodes tumors patients who received R0 resection alone | – | Procedure: R0 resection |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients pathologically diagnosed with BoPT and MPT who underwent surgery at three medical institutions in China: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Sun Yat-sen University Cancer Center, and the Third Affiliated Hospital of Nanchang University.
Key inclusion criteria (1 listed)
- patients who were initially diagnosed with BoPT or MPT and underwent R0 resection surgery
Key exclusion criteria (5 listed)
- patients who had their initial surgery at other hospitals without accurate baseline data
- patients who received radiotherapy before surgery
- those presenting with initial distant metastasis before treatment
- patients lost to follow-up after treatment
- patients with a history of or concurrent breast cancer or precancerous lesions in the ipsilateral breast or with breast cancer in the contralateral breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant RadiotherapyPostoperative Radiotherapy with 3D-CRT and IMRT Techniques Following R0 Resection in BoPT and MPT Patients | Radiation | Phyllodes tumors patients who received radiotherapy afte R0 resection |
| R0 resectionPatients who received R0 resection (complete resection without tumor margin) | Procedure or surgery | Phyllodes tumors patients who received R0 resection alone, Phyllodes tumors patients who received radiotherapy afte R0 resection |
Primary outcome
5-year Local Recurrence-free Survival
Time frame: Five years
The time period from the initial R0 resection to either the detection of local recurrence or the final follow-up.
1 secondary outcome
5-year Overall Survival
Time frame: Five years
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 17 Jan 2025.
- Background: PubMed 16998937Macdonald OK, Lee CM, Tward JD, Chappel CD, Gaffney DK. Malignant phyllodes tumor of the female breast: association of primary therapy with cause-specific survival from the Surveillance, Epidemiology, and End Results (SEER) program. Cancer. 2006 Nov 1;107(9):2127-33. doi: 10.1002/cncr.22228.
- Background: PubMed 11843853Pandey M, Mathew A, Kattoor J, Abraham EK, Mathew BS, Rajan B, Nair KM. Malignant phyllodes tumor. Breast J. 2001 Nov-Dec;7(6):411-6. doi: 10.1046/j.1524-4741.2001.07606.x.
- Background: PubMed 33865208Boutrus RR, Khair S, Abdelazim Y, Nasr S, Ibraheem MH, Farahat A, El Sebaie M. Phyllodes tumors of the breast: Adjuvant radiation therapy revisited. Breast. 2021 Aug;58:1-5. doi: 10.1016/j.breast.2021.03.013. Epub 2021 Apr 7.
- Background: PubMed 36328344Yu CY, Huang TW, Tam KW. Management of phyllodes tumor: A systematic review and meta-analysis of real-world evidence. Int J Surg. 2022 Nov;107:106969. doi: 10.1016/j.ijsu.2022.106969. Epub 2022 Oct 31.
- Background: PubMed 31111353Li J, Tsang JY, Chen C, Chan SK, Cheung SY, Wu C, Kwong A, Hu J, Hu H, Zhou D, Tse GM. Predicting Outcome in Mammary Phyllodes Tumors: Relevance of Clinicopathological Features. Ann Surg Oncol. 2019 Sep;26(9):2747-2758. doi: 10.1245/s10434-019-07445-1. Epub 2019 May 20.
- Background: PubMed 17931796Belkacemi Y, Bousquet G, Marsiglia H, Ray-Coquard I, Magne N, Malard Y, Lacroix M, Gutierrez C, Senkus E, Christie D, Drumea K, Lagneau E, Kadish SP, Scandolaro L, Azria D, Ozsahin M. Phyllodes tumor of the breast. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):492-500. doi: 10.1016/j.ijrobp.2007.06.059. Epub 2007 Oct 10.
- Background: PubMed 18234448Pezner RD, Schultheiss TE, Paz IB. Malignant phyllodes tumor of the breast: local control rates with surgery alone. Int J Radiat Oncol Biol Phys. 2008 Jul 1;71(3):710-3. doi: 10.1016/j.ijrobp.2007.10.051. Epub 2008 Jan 30.
- Background: PubMed 8522284Moffat CJ, Pinder SE, Dixon AR, Elston CW, Blamey RW, Ellis IO. Phyllodes tumours of the breast: a clinicopathological review of thirty-two cases. Histopathology. 1995 Sep;27(3):205-18. doi: 10.1111/j.1365-2559.1995.tb00212.x.
- Background: PubMed 36579383Md Nasir ND, Koh VCY, Cree IA, Ruiz BII, Del Aguila J, Armon S, Fox SB, Lakhani SR, Tan PH. Phyllodes tumour evidence gaps mapped from the 5th edition of the WHO classification of tumours of the breast. Histopathology. 2023 Apr;82(5):704-712. doi: 10.1111/his.14856. Epub 2023 Jan 30.
- Individual participant dataSharing planned: No. no plan to make individual participant data available to other researchers.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy, Adjuvant and Phyllodes Breast Tumor, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites 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 1 inclusion and 5 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
5-year Local Recurrence-free Survival (time frame: Five years). 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 NCT06780059, which also lists 9 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 17 Jan 2025.