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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT03657069
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy
* No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation
* Ability to understand and the willingness to sign a written informed consent document
* No life expectancy restrictions
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
* No requirements for organ and marrow function
Exclusion Criteria:
* Recent steroid use
* No major medical comorbidities (defined as American Society of Anesthesiologists \[ASA\] III or greater)
* No connective tissue disorder
* Prior breast surgery, excluding biopsy and lumpectomy
* History of or plan for breast radiation
* Pregnancy and nursing patients will be excluded from the study
* No restrictions regarding use of other investigational agents
* No exclusion criteria related to history of allergic reactions
* No exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent
* No other agent-specific exclusion criteria
* No exclusion of cancer survivors or those who are human immunodeficiency virus (HIV)-positive
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03657069
Study Brief:
Protocol Section:
NCT03657069