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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02295033
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented invasive adenocarcinoma (any subtype) of the breast with clinical stage T1-2 (0-5 cm) and pathologic stage N0-1, M0 disease
* Lumpectomy with 1-2 cm margin required within 9 weeks of initiation of protocol radiotherapy
* Axillary dissection required for premenopausal patients and recommended for postmenopausal patients (Irradiation of clinically negative axilla is an acceptable alternative to axillary dissection in postmenopausal patients)
Exclusion Criteria:
* Residual microcalcification on postoperative mammogram
* Gross residual disease in the breast (re-excision allowed if there is gross residual disease after first surgical procedure)
* Multiple foci of tumor in more than 1 quadrant
* Previous or concurrent malignant tumor in contralateral breast
* In situ carcinoma of the breast, without invasive tumor
* Tumorectomy performed more than 9 weeks before the start of radiotherapy in cases where no adjuvant chemotherapy is given and more than 6 months before the start of radiotherapy if chemotherapy is given
* Previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
* Concurrent pregnancy or lactation
* Eastern Cooperative Oncology Group performance scale more than 2
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
70 Years
Study:
NCT02295033
Study Brief:
Protocol Section:
NCT02295033