Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

Dartmouth-Hitchcock Medical Center46 enrolled

Overview

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.

OBJECTIVES: * Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy. * Determine the survival rate in patients treated with this regimen. METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Adjuvant RadiotherapyRADIATION

Adjuvant radiation therapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Local Recurrence Rate

Local recurrence rate of phyllodes tumors

Time frame: 36 months after initial excision

Secondary Outcomes

Survival Rate

Survival will be tracked for 10 years after initial resection of first participant treated.

Time frame: Approximately 5 years

Data from ClinicalTrials.gov

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