N/A
N=46
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00003404 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Local Recurrence Rate — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adjuvant Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Recurrence Rate |
— | — |
| SECONDARY Survival Rate |
2 | — |
Summary
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:
- Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia
- Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia
- Must have been excised with breast-conserving resection and no positive margins
- Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
- No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
- Hormone receptor status: Not specified
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Sex: Female
- Menopausal status: Not specified
- Performance status: Not specified
- Life expectancy: Not specified
- Hematopoietic: Not specified
- Hepatic: Not specified
- Renal: Not specified
- Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Biologic therapy: Not specified
- Chemotherapy: Not specified
- Endocrine therapy: Not specified
- Radiotherapy: No prior radiotherapy to the ipsilateral breast
- Surgery: See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00003404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.