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

ClinicalTrials.gov ID

NCT07657169

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

160Estimated

Last Update Posted

Jun 18, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

Official Title

Efficacy and Safety of Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Prospective, Open-Label, Randomized Controlled Trial

Brief 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.

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

• Postoperative Radiotherapy (PORT)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Female patients aged ≥18 years and ≤75 years.
2. Histologically confirmed breast phyllodes tumor (PT) by the central laboratory, with molecular classification as MN1 or MN2 subtype via transcriptome sequencing or IHC;
3. Primary or ipsilateral local recurrence following R0 resection (negative margins) before enrollment;
4. Pathologically confirmed borderline or malignant PT;
5. No evidence of distant metastasis (M0);
6. ECOG performance status 0-1;
7. Signed informed consent before treatment;
8. Expected randomization and study entry within 8-12 weeks (no later than 16 weeks) after surgery.

Exclusion Criteria:

1. Previous radiation to the same-side breast or chest;
2. women, or those of childbearing potential refusing effective contraception; Pregnancy, lactation, or refusal of contraception by fertile subjects;
3. Grade III-IV bone marrow suppression: WBC≤1.9*109/L，ANC≤0.9*109/L，PLT≤49*109/L，AST, ALT≥2*ULN;
4. Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
5. Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
6. Prior or planned systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, or investigational agents) during the study;
7. Participation in other clinical trials that precludes study inclusion;
8. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for the trial.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

+86 13828832157

fei.wang@sdu.edu.cn+86 17660083882

hbwang66@qdu.edu.cn+86 18661805787

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