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NCT06780059
Effects of Radiotherapy in Borderline and Malignant Phyllodes Tumors After R0 Resection
trial testing Adjuvant Radiotherapy in Radiotherapy, Adjuvant in 480 participants. Completed in 2 January 2025.
2 January 2025
Quick facts
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 480 |
| Start date | 30 December 2024 |
| Primary completion | 2 January 2025 |
| Estimated completion | 2 January 2025 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Adjuvant Radiotherapy
- R0 resection
Conditions studied
- Radiotherapy, Adjuvant — all drugs for Radiotherapy, Adjuvant →
- Phyllodes Breast Tumor — all drugs for Phyllodes Breast Tumor →
- Prognosis — all drugs for Prognosis →
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Who can join
Eligibility, female only, with Radiotherapy, Adjuvant or Phyllodes Breast Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of radiotherapy in borderline and malignant phyllodes tumors after R0 resection: a propensity score analysis.
Ma B, Li X, Zhuang Z, Han M, et al · · 2025 · PMID 41179117 · DOI 10.1177/17588359251387556
Verify or expand the search:
- PubMed search for NCT06780059
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06780059 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Last refreshed: 17 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06780059.
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