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 with breast cancer that has been confirmed by a tissue test (biopsy) and is either locally advanced, cannot be surgically removed, or has spread to other parts of the body.
• People whose breast cancer is 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 who are not considered suitable candidates for those treatments.
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
• People with available tumour tissue (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 light activity and care for themselves, as assessed by a standard medical scoring system called ECOG (score of 0 or 1).
• People whose blood counts, liver, kidney, and heart function all meet specific minimum levels set out by the trial (confirm exact thresholds with the trial site).
• People whose heart is pumping at least 45% of its normal capacity and who do not have an uncontrolled irregular heartbeat.
• People who test negative for pregnancy before joining, and who agree to use effective contraception during treatment and for 6 months after the last treatment dose (applies to those who could become pregnant).
• People who are able to understand the study and are willing to sign a consent form.

Who may not be able to join:

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

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