Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00003404
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00003404
Study Brief:
Protocol Section:
NCT00003404