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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT07074106
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed primary invasive breast carcinoma.
* One of the following conditions:
* Clinical stage T1c N0 M0 with any level of TILs; or
* Clinical stage T2 N0 M0 with TILs ≥ 50%.
* Estrogen receptor (ER) and progesterone receptor (PR) expression \< 10%.
* HER2-negative or non-amplified, according to current ASCO-CAP criteria.
* No evidence of distant metastasis based on imaging performed prior to study entry (chest/abdomen/pelvis CT scan or FDG PET-CT).
* Age ≥ 18 years.
* ECOG performance status of 0 to 2.
* Adequate organ function
Exclusion Criteria:
* The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), active ischemic heart disease, or chronic liver or kidney disease.
* Pregnant or breastfeeding participants.
* History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07074106
Study Brief:
Protocol Section:
NCT07074106