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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT02183805
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) 0 or 1.
* Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
* Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).
* Obtained complete response or Good partial response after first line chemotherapy.
* Normal organ function required prior to study entry.
* Willingness to comply with treatment plans and other study procedures.
Exclusion Criteria:
* Uncontrolled central nervous system (CNS) involvement with disease
* Fertile women unwilling to use contraceptive techniques during treatment
* Females who are pregnant
* Organ dysfunction.
* Patients may not be receiving any other investigational agents.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02183805
Study Brief:
Protocol Section:
NCT02183805