NCT07657169Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Randomized Controlled Trial
Efficacy and Safety of Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Prospective, Open-Label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 15 Jun 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- NCT number
- NCT07657169
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 1 Jun 2026 to the primary completion date, 31 Dec 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation to the same-side breast or chest;
- Prior or planned systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, or investigational agents) during the study;
Other illness
- Any other condition that, in the opinion of the investigator, renders the patient unsuitable for the trial.
Lab values
- 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%;
Other
- women, or those of childbearing potential refusing effective contraception; Pregnancy, lactation, or refusal of contraception by fertile subjects;
- Participation in other clinical trials that precludes study inclusion;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.