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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03881605
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18
2. Triple negative or HER2+ breast cancer (ASCO/CAP guidelines 2018)\*
3. MBC, as defined as distant disease outside of the breast and local/regional lymph nodes. Physicians' clinical judgment will be used to determine the possible need for biopsy in confirming a MBC diagnosis. However, biopsy of a metastatic site is not required for pathologic confirmation of stage IV disease.
4. Diagnosis of metastatic disease within 12 weeks prior to study enrollment.
5. No symptoms of BrM or known asymptomatic BrM at study entry.
6. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may participate.
* This will generally be based on the primary cancer but in the event that a metastatic site is biopsied eligibility will be based on the ER, PR and HER2 profile of the metastasis.
Exclusion Criteria:
1. Inability to participate in an MRI screening program as determined by the patient and/or physician. This may be on the basis of severe claustrophobia, performance status that limits additional testing, or a metal foreign body that would prevent MRI imaging.
2. Inability to provide informed consent. Notably participants who require translators are allowed to enroll.
3. Creatinine clearance \<30 mL/min using the Cockcroft-Gault equation.
4. Established need for brain imaging apart from the breast cancer diagnosis (e.g surveillance for an aneurysm).
5. ECOG Performance status \>2.
6. Pregnancy.
7. Grade 3+ allergy to Gadavist IV contrast (CTEP Adverse Event Reporting System).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03881605
Study Brief:
Protocol Section:
NCT03881605