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Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Randomized Controlled Trial

NCT07657169 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-06-18

No results posted yet for this study

Summary

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.

Conditions

  • Radiotherapy, Adjuvant
  • Phyllodes Breast Tumor
  • Prognosis
  • Molecular Typing

Interventions

RADIATION

Postoperative Radiotherapy (PORT)

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07657169 on ClinicalTrials.gov