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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01189851
Eligibility Criteria:
Inclusion Criteria:
1. Informed Consent. Each eligible patient must willingly give written consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
2. Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast.
3. Female, age ≥ 48 years.
4. Clinically and/or histologically negative axillary lymph nodes.
5. No imaging or clinical findings that indicate metastatic disease.
6. Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist.
Exclusion Criteria:
1. Male sex
2. Age \< 48
3. Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer
4. Pregnancy or lactation
5. Serious psychiatric or addictive disorders
6. More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI.
7. Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist.
8. Ipsilateral breast with a previous cancer and/or irradiation.
9. Extensive Intraductal Component (DCIS ≥ 25% of the tumor).
10. Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled.
11. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
12. Lymphovascular invasion on needle biopsy.
13. Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
48 Years
Study:
NCT01189851
Study Brief:
Protocol Section:
NCT01189851