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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT00818051
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* Resectable, unilateral disease
* T1-3, N0-1, M0 disease
* Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer
* Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
* Age 18-49 years
* Tumor size \> 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
* Tumor of any size treated by primary medical therapy
* Grade III disease
* Minimum microscopic margin of noncancerous tissue \< 5 mm (excluding deep margin if at deep fascia)
* Lymphovascular invasion
* Axillary node positive
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior mastectomy
* No concurrent chemotherapy except primary or sequential chemotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00818051
Study Brief:
Protocol Section:
NCT00818051