At a glance
ClinicalIndex Comparison Record- ✓Metastatic or locally recurrent unresectable breast cancer that is currently progressive after at least two prior lines of therapy in the advanced setting
- ✓HER2+ patients must have failed two or more different anti-HER2 agents
- ✓Measurable or evaluable disease per RECIST 1.1 criteria
- ✓Life expectancy greater than or equal to 12 weeks
- ✕Severe intercurrent infection
- ✕Receiving systemic corticosteroids (off steroids ≥48 hours is acceptable)
- ✕Pregnant or lactating
- ✕HIV positive
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tumor Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Breast Cancer
In Brief
A Phase 2 clinical trial evaluating TAA-specific CTLs for Breast Cancer. Completed, enrolled 12 participants across 2 sites.
Detailed Summary
Status - CLOSED TO PATIENT ENROLLMENT (CNPE) The study is being conducted in patients in which breast cancer has come back after standard treatment. Volunteers in this research study are treated using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy. The proteins that investigators are targeting in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, investigators target five common TAAs. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe. Investigators now want to try this treatment in patients with breast cancer. These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to determine the clinical efficacy of TAA-specific CTLs, to learn what the side-effects are, and to see whether this therapy might help patients with breast cancer.
Study Details
Timeline
Interventions
Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.