Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Randomized Controlled Trial
15. juni 2026 oppdatert av: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Efficacy and Safety of Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Prospective, Open-Label, Randomized Controlled Trial
Phyllodes tumor (PT) of the breast is a rare fibroepithelial neoplasm, and the role of postoperative radiotherapy (PORT) remains controversial.
Our team has previously established a molecular subtyping system for PT, classifying patients into four subtypes.
Among them, the malignant novel 1/2 (MN1/MN2) subtypes exhibit extremely high risk of local recurrence, and retrospective data suggest that PORT may significantly improve local control in these subtypes.
This study aims to evaluate the efficacy and safety of molecular subtype-guided postoperative radiotherapy (PORT) in patients with MN-subtype phyllodes tumor of the breast.
This prospective, multicenter, open-label, randomized controlled trial plans to enroll 160 patients with molecularly confirmed MN1 or MN2 subtype who have undergone R0 resection.
Patients will be randomized in a 1:1 ratio to either the PORT group or the observation-only group, with stratification by negative margin width (<1 cm vs. ≥1 cm) and molecular subtype (MN1 vs. MN2).
The primary endpoint is 2-year local recurrence-free survival (LRFS).
Secondary endpoints include distant metastasis-free survival (DMFS), disease-free survival (DFS), overall survival (OS), and the incidence of acute and late radiotherapy-related toxicities.
By using an innovative molecular subtyping system to precisely select the target population, this study seeks to assess the benefit and safety of PORT in MN-subtype phyllodes tumors.
The results are expected to provide the highest level of evidence for this specific subgroup, advance treatment strategies toward "molecular subtype-guided precision radiotherapy," improve patient outcomes, and inform future clinical guidelines.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
160
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yan Nie
- Telefonnummer: +86 020-81332587
- E-post: nieyan7@mail.sysu.edu.cn
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Ta kontakt med:
- Yan Nie
- Telefonnummer: +86 020-81332587
- E-post: nieyan7@mail.sysu.edu.cn
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Shenzhen, Guangdong, Kina, 518000
- Peking University Shenzhen Hospital
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Ta kontakt med:
- Junwei Cui
- Telefonnummer: +86 13828832157
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Shandong
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Jinan, Shandong, Kina, 250033
- The Second Hospital of Shandong University
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Ta kontakt med:
- Fei Wang
- Telefonnummer: +86 17660083882
- E-post: fei.wang@sdu.edu.cn
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Qingdao, Shandong, Kina, 266003
- The Affiliated Hospital of Qingdao University
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Ta kontakt med:
- Haibo Wang
- Telefonnummer: +86 18661805787
- E-post: hbwang66@qdu.edu.cn
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Female patients aged ≥18 years and ≤75 years.
- Histologically confirmed breast phyllodes tumor (PT) by the central laboratory, with molecular classification as MN1 or MN2 subtype via transcriptome sequencing or IHC;
- Primary or ipsilateral local recurrence following R0 resection (negative margins) before enrollment;
- Pathologically confirmed borderline or malignant PT;
- No evidence of distant metastasis (M0);
- ECOG performance status 0-1;
- Signed informed consent before treatment;
- Expected randomization and study entry within 8-12 weeks (no later than 16 weeks) after surgery.
Exclusion Criteria:
- Previous radiation to the same-side breast or chest;
- women, or those of childbearing potential refusing effective contraception; Pregnancy, lactation, or refusal of contraception by fertile subjects;
- Grade III-IV bone marrow suppression: WBC≤1.9*109/L，ANC≤0.9*109/L，PLT≤49*109/L，AST, ALT≥2*ULN;
- Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
- Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
- Prior or planned systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, or investigational agents) during the study;
- Participation in other clinical trials that precludes study inclusion;
- Any other condition that, in the opinion of the investigator, renders the patient unsuitable for the trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Observasjon
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Eksperimentell: Postoperative Radiotherapy (PORT)
Patients receive postoperative radiotherapy starting within 8-12 weeks (max 16 weeks) after R0 resection.
For breast-conserving surgery: whole-breast irradiation (50 Gy/25 fractions) plus sequential tumor bed boost (10-16 Gy/5-8 fractions).
For mastectomy: chest wall irradiation (50 Gy/25 fractions).
No routine regional nodal irradiation unless pathologically positive.
Acute and late toxicities monitored per CTCAE v5.0.
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Radiotherapy delivered after R0 resection.
For breast-conserving surgery: whole-breast irradiation (50 Gy in 25 fractions, 2 Gy/fraction, 5 fractions/week) followed by sequential tumor bed boost (10-16 Gy in 5-8 fractions, 2 Gy/fraction).
For mastectomy: chest wall irradiation (50 Gy in 25 fractions).
Techniques allowed: IMRT, VMAT, or TOMO.
No routine regional nodal irradiation unless pathologically confirmed nodal involvement.
Target volume and organ-at-risk constraints as per protocol (e.g., ipsilateral lung Dmean <15 Gy, heart Dmean <5 Gy for left-sided tumors).
Acute and late toxicities assessed by CTCAE v5.0.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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2-year Local Recurrence-Free Survival (LRFS)
Tidsramme: From randomization up to 2 years post-randomization (primary analysis at 2 years)
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Time from randomization to the first documented locoregional recurrence (ipsilateral breast/chest wall or regional lymph nodes) confirmed by imaging and/or pathology, or death from any cause, whichever occurs first.
Patients alive without locoregional recurrence are censored at the date of last known follow-up.
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From randomization up to 2 years post-randomization (primary analysis at 2 years)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Distant Metastasis-Free Survival (DMFS)
Tidsramme: From randomization up to 5 years (primary analysis for secondary endpoints will be performed at 2 years, with extended follow-up up to 5 years)
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From randomization up to 5 years (primary analysis for secondary endpoints will be performed at 2 years, with extended follow-up up to 5 years)
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Disease-Free Survival (DFS)
Tidsramme: From randomization up to 5 years (primary analysis of secondary endpoints at 2 years, with extended follow-up to 5 years)
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From randomization up to 5 years (primary analysis of secondary endpoints at 2 years, with extended follow-up to 5 years)
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Overall Survival (OS)
Tidsramme: From randomization up to 5 years
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From randomization up to 5 years
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Incidence of Acute and Late Radiotherapy-Related Toxicities
Tidsramme: From start of radiotherapy up to 5 years post-randomization (acute: within 90 days; late: from 90 days to 5 years)
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Proportion of patients experiencing adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Acute toxicity is defined as events occurring within 90 days after start of radiotherapy; late toxicity as events occurring >90 days after start of radiotherapy.
Includes radiation dermatitis, radiation pneumonitis, cardiac toxicity, rib fracture, breast/chest wall fibrosis, and secondary malignancies.
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From start of radiotherapy up to 5 years post-randomization (acute: within 90 days; late: from 90 days to 5 years)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Zheng WH, Long ZQ, Kou J, Sun JY, Li FY, Zhang LL, He ZY. Postoperative radiation therapy in localized breast malignant phyllodes tumors: RPA-derived risk model identifies high-benefit subgroups with local control improvement. Breast. 2025 Dec;84:104617. doi: 10.1016/j.breast.2025.104617. Epub 2025 Oct 22.
- Kim YJ, Kim K. Radiation therapy for malignant phyllodes tumor of the breast: An analysis of SEER data. Breast. 2017 Apr;32:26-32. doi: 10.1016/j.breast.2016.12.006. Epub 2016 Dec 22.
- Ma B, Li X, Zhuang Z, Han M, Zhang Y, Ye F, Bi Z, Deng W, Zhang J, Yang Y, Nie Y. Effects of radiotherapy in borderline and malignant phyllodes tumors after R0 resection: a propensity score analysis. Ther Adv Med Oncol. 2025 Oct 27;17:17588359251387556. doi: 10.1177/17588359251387556. eCollection 2025.
- Varghese SS, Sasidharan B, Manipadam MT, Paul MJ, Backianathan S. Radiotherapy in Phyllodes Tumour. J Clin Diagn Res. 2017 Jan;11(1):XC01-XC03. doi: 10.7860/JCDR/2017/24591.9167. Epub 2017 Jan 1.
- Zhao W, Tian Q, Zhao A, Wang B, Yang J, Wang L, Zhang L, Dong D, Chen L, Yang J. The role of adjuvant radiotherapy in patients with malignant phyllodes tumor of the breast: a propensity-score matching analysis. Breast Cancer. 2021 Jan;28(1):110-118. doi: 10.1007/s12282-020-01135-7. Epub 2020 Aug 3.
- Barth RJ Jr, Wells WA, Mitchell SE, Cole BF. A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol. 2009 Aug;16(8):2288-94. doi: 10.1245/s10434-009-0489-2. Epub 2009 May 8.
- Donato AR, Goncalves R, Maesaka JY, Aguiar FN, Soares JM Jr, Ruiz CA, Filassi JR, Baracat EC. Phyllodes tumors of the breast: A comprehensive review of diagnosis, treatment, and follow-up. Clinics (Sao Paulo). 2025 Mar 14;80:100617. doi: 10.1016/j.clinsp.2025.100617. eCollection 2025.
- Zhang H, Tang S, Biskup E, Zhang Y, Yong L, Chen L, Cai F. Long-term Survival After Diverse Therapeutic Modalities in Malignant Phyllodes Tumors of the Breast. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221121086. doi: 10.1177/15330338221121086.
- Gradishar WJ, Moran MS, Abraham J, Abramson V, Aft R, Agnese D, Allison KH, Anderson B, Bailey J, Burstein HJ, Chen N, Chew H, Dang C, Elias AD, Giordano SH, Goetz MP, Jankowitz RC, Javid SH, Krishnamurthy J, Leitch AM, Lyons J, McCloskey S, McShane M, Mortimer J, Patel SA, Rosenberger LH, Rugo HS, Santa-Maria C, Schneider BP, Smith ML, Soliman H, Stringer-Reasor EM, Telli ML, Wei M, Wisinski KB, Yeung KT, Young JS, Schonfeld R, Kumar R. Breast Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 Jul;22(5):331-357. doi: 10.6004/jnccn.2024.0035.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
31. desember 2030
Studiet fullført (Antatt)
31. desember 2030
Datoer for studieregistrering
Først innsendt
15. juni 2026
Først innsendt som oppfylte QC-kriteriene
15. juni 2026
Først lagt ut (Faktiske)
18. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SYSKY-2026-390-02
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Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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