Clinical trial · Interventional
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
NCT00003404CI-TRIAL-00036659completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PURPOSE: This phase II trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast. RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adjuvant Radiotherapy
- description
- Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
- interventionNames
- Radiation: Adjuvant Radiotherapy
Primary outcomes (1)
- measure
- Local Recurrence Rate
- timeFrame
- 36 months after initial excision
- description
- Local recurrence rate of phyllodes tumors
Secondary outcomes (1)
- measure
- Survival Rate
- timeFrame
- Approximately 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: 1. Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following: 1. Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia 2. Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia 2. Must have been excised with breast-conserving resection and no positive margins 3. Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision 4. No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast 5. Hormone receptor status: Not specified PATIENT CHARACTERISTICS: 1. Age: 18 and over 2. Sex: Female 3. Menopausal status: Not specified 4. Performance status: Not specified 5. Life expectancy: Not specified 6. Hematopoietic: Not specified 7. Hepatic: Not specified 8. Renal: Not specified 9. Other: 1. Not pregnant 2. Negative pregnancy test 3. Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: 1. Biologic therapy: Not specified 2. Chemotherapy: Not specified 3. Endocrine therapy: Not specified 4. Radiotherapy: No prior radiotherapy to the ipsilateral breast 5. Surgery: See Disease Characteristics
References
Publications (1)
- RESULTBarth 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. PMID 19424757