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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT07069595
Eligibility Criteria:
Inclusion Criteria:
Written informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information.
* Participant is willing and able to comply with study procedures based on the judgment of the investigator.
* Age ≥ 18 years at the time of consent.
* Histological confirmation of TNBC defined by ER/PR \<10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative.
* Stage II/III TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II/III at time of surgery.
* Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease.
* The participant must have archival diagnostic tissue and/or surgical resection tissue Available.
* Participants are willing and able to comply with study procedures based on the judgment of the investigator.
Exclusion Criteria:
• Participants are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07069595
Study Brief:
Protocol Section:
NCT07069595