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

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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.