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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00156260
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age
2. biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ
3. patient desires or requires treatment with mastectomy
4. any patient who has undergone prior excisional biopsy of their primary breast tumor must have had margins positive for disease, or must have either mammographic or ultrasonographic evidence of probable residual disease in the breast.
5. patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible.
6. voluntarily signed informed consent. -
Exclusion Criteria:
1. male gender
2. lobular carcinoma in situ as the only cancerous histology
3. prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease
4. patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00156260
Study Brief:
Protocol Section:
NCT00156260