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 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT06240195
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Histological diagnosis of TNBC;
* Locally advanced unresectable or metastatic disease;
* Indication for treatment with SG in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage);
* Availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (IRE);
* Written informed consent;
* Availability to comply with the procedures established by the protocol, according to the methods and times described.
Exclusion Criteria:
* Patients with a history of other malignancies;
* Contraindications to the use of sacituzumab govitecan SG;
* Untreated and/or clinically unstable (symptomatic) brain metastases.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06240195
Study Brief:
Protocol Section:
NCT06240195