Breast Cancer
Conditions
Keywords
recurrent breast cancer, phyllodes tumor
Brief 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.
Detailed description
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.
Interventions
RADIATIONAdjuvant Radiotherapy
Adjuvant radiation therapy
Sponsors
National Cancer Institute (NCI)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Recurrence Rate | 36 months after initial excision | Local recurrence rate of phyllodes tumors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | Approximately 5 years | Survival will be tracked for 10 years after initial resection of first participant treated. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled from a total of 30 different institutions. Half of the patients were treated at community-based treatment centers, and half were treated at academic medical centers.
Participants by arm
| Arm | Count |
|---|---|
| Adjuvant Radiotherapy Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | Adjuvant Radiotherapy |
|---|---|
| Age, Continuous | 49 years |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Local Recurrence Rate
Local recurrence rate of phyllodes tumors
Time frame: 36 months after initial excision
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adjuvant Radiotherapy | Local Recurrence Rate | 0 Participants |
95% CI: [0, 8]
Secondary
Survival Rate
Survival will be tracked for 10 years after initial resection of first participant treated.
Time frame: Approximately 5 years
Population: All patients received adjuvant radiotherapy as specified in the protocol. No patients were lost to follow-up. Duration of follow-up ranged from 12 to 129 months, with a median follow-up of 56 months and a mean follow-up of 60 months. Ninety percent of the patients were followed for at least 2 years.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adjuvant Radiotherapy | Survival Rate | 2 Participants |