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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT06727357
Eligibility Criteria:
Inclusion Criteria:
* Patients (women or men) with histologically confirmed metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Written informed consent obtained prior to enrollment
* Age ≥ 18 years
* Blood and tumor tissue sample available for research
* Measurable disease
* Other site accessible for biopsy, except bone lesions if this is the only accessible site, or biopsy obtained within the previous 6 months
* Medical history, blood parameters and clinical conditions do not indicate major dysfunctions of organ
To treatment:
\- Maintenance of screening inclusion criteria
Exclusion Criteria:
* Presence of visceral crisis, defined according to ABC3/ESMO guidelines
* Patients with local recurrence that can be treated with surgery and/or radiotherapy alone
* Patients who have previously received palliative radiotherapy on the only site accessible to biopsy
* Patients with metastatic disease limited to bone
* Patients with metastatic disease limited to the brain, unless planned a surgical excision, in which case tissue can be collected for screening
* Severe hematopoietic, renal and/or hepatic insufficiency
* Known contraindication to biopsy
* Neoplastic pathology of different histology in the previous 5 years, except carcinoma in situ of cervical basal or squamous cell carcinoma of the skin, if adequately treated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06727357
Study Brief:
Protocol Section:
NCT06727357