Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with breast cancer (confirmed by tissue testing) that has spread, cannot be surgically removed, or is locally advanced.
• People whose breast cancer is classified as either HER2-positive or triple-negative (TNBC) — two specific subtypes identified by laboratory testing.
• People whose cancer has continued to grow after standard treatments, who could not tolerate standard treatments, or for whom standard treatments are not considered appropriate.
• People who have at least one tumour that can be measured on scans, according to standard measurement guidelines.
• People who have tumour tissue available (either a recent sample or one stored from a previous biopsy) that shows the presence of at least one specific protein marker (HER2/ERBB2, MUC1, or ROR1).
• People who are generally well enough to carry out normal daily activities with little or no limitation (assessed using a standard medical scale called ECOG, scored 0 or 1).
• People whose blood counts, liver function, kidney function, and other organ measurements fall within the acceptable ranges required by the trial (confirm with trial site for specific thresholds).
• People whose heart is pumping adequately (at least 45% efficiency) and who do not have an uncontrolled irregular heartbeat.
• People who test negative for pregnancy before joining, if there is any possibility of becoming pregnant, and who agree to use reliable contraception during treatment and for 6 months after the last treatment session.
• People who are able to understand the study information and are willing to sign a consent form.

Who may not be able to join:

• People who have cancer that has spread to the brain or the lining around the brain or spinal cord and has not yet been treated or is not stable — though people with previously treated brain metastases that have been stable for at least 4 weeks and no longer require high-dose steroids may still be considered (confirm with trial site).
• People who have received a previous gene-modified cell therapy (such as CAR-T or CAR-NK therapy) within the last 6 months, or who still have significant side effects from a previous cell therapy.
• People who have an active autoimmune disease that requires ongoing treatment with immune-suppressing medications.
• People who have an active, uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, or HIV — though people with infections that are well-controlled may be considered by the trial team (confirm with trial site).
• People who have had a serious allergic reaction to the medications fludarabine or cyclophosphamide in the past.
• People who are currently pregnant or breastfeeding.
• People who are already taking part in another clinical intervention study that could affect the results of this trial.
• People who have any other health condition that the trial doctor believes would make participation unsafe or unsuitable.

Important: Always verify eligibility with the trial site directly before applying.