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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT07136493
Eligibility Criteria:
Inclusion Criteria:
* Documented written informed consent of the participant
* Age ≥ 18 years
* Diagnosis of stage I-III breast cancer (any gender)
* Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
* Willingness to:
* Provide blood samples
* Provide archival tumor tissue sample (only necessary for Cohort 2 if analysis of surgical tissue was not successful)
* Provide tumor tissue sample from resection/surgery (only necessary for Cohort 1 if analysis of surgical tissue was not successful)
* Permit medical record review
* Fall into one of the following categories defined below: Cohort 1, Subgroup A or B OR Cohort 2
* COHORT 1: Must have archival diagnostic tissue available
* COHORT 1: Scheduled to undergo, but has not yet begun, neoadjuvant systemic therapy followed by curative resection
* COHORT 1 (Subgroup A): HER2+ by current American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines (any ER/PR status)
* COHORT 1 (Subgroup B): Triple negative (ER, PR and HER2 negative). Defined as ER and PR ≤ 10% by immunohistochemistry (IHC) and HER2 negative, by current ASCO/CAP guidelines
* COHORT 2: Scheduled to undergo upfront curative surgical resection with or without adjuvant chemotherapy followed by adjuvant endocrine therapy
* COHORT 2: ER+/any PR/HER2- (ER positive defined as ER \> 10% by IHC)
Exclusion Criteria:
* Ductal carcinoma in situ
* Inability to safely provide sequential blood samples
* Prior or concurrent invasive malignancy (unless disease free \> 5 years)
* An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
* A direct study team member
* Inability to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07136493
Study Brief:
Protocol Section:
NCT07136493