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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT03093350
Eligibility Criteria:
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
PROCUREMENT INCLUSION CRITERIA:
1. Any breast cancer patient with metastatic or locally recurrent unresectable disease.
2. Patients with life expectancy greater than or equal to 12 weeks.
3. Age greater than or equal to 18 and less than or equal to 80 years old.
4. Hgb greater than or equal to 7.0.
5. Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
TREATMENT INCLUSION CRITERIA:
1. Any breast cancer patient with metastatic or locally recurrent unresectable breast cancer currently progressive, after at least two prior lines of therapy in the advanced setting. Patients with HER2+ disease must have failed two or more different anti-HER2 agents.
2. Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
3. Patients with life expectancy greater than or equal to 12 weeks.
4. Age greater than or equal to 18 and less than or equal to 80 years old.
5. Pulse oximetry of greater than 95% on room air.
6. Patients with ECOG score less than or equal to 2 or a Karnofsky score of greater than or equal to 50.
7. Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, and Hgb greater than or equal to 7.0.
8. Patients with a creatinine normal for age.
9. Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
10. Patients should have been off conventional therapy for at least 1 week prior to receiving treatment on this study.
11. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion.
12. Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
PROCUREMENT EXCLUSION CRITERIA:
1. Patients with severe intercurrent infection.
2. Patients with active HIV infection at time of procurement.
3. Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation.
TREATMENT EXCLUSION CRITERIA:
1. Patients with severe intercurrent infection.
2. Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible).
3. Pregnant or lactating.
4. Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation.
5. HIV positive.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03093350
Study Brief:
Protocol Section:
NCT03093350