Phase 2 Breast Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older who have been diagnosed with metastatic breast cancer confirmed by laboratory testing, where the cancer tests negative for estrogen receptor (ER), progesterone receptor (PR), and HER2 (commonly called "triple-negative" breast cancer).
• People who are willing to provide a stored tumour tissue sample from the metastatic cancer site, and who agree to have a research biopsy taken before treatment begins and during the second cycle of treatment, if a suitable lesion is accessible and the treating doctor agrees.
• People who have already received at least two rounds of systemic treatment (such as chemotherapy) for their advanced cancer, and whose last treatment ended more than 14 days before joining the trial.
• People who are reasonably able to carry out daily activities (assessed using a standard medical scale called ECOG, with a score of 2 or lower, meaning some limitation is acceptable).
• People whose blood counts and organ function meet specific minimum levels, including healthy enough levels of white blood cells, red blood cells, platelets, liver enzymes, bilirubin, and kidney function (confirm with trial site for exact values).
• People who have cancer that has spread to the brain, provided that spread has been treated and has been stable for at least 4 weeks, confirmed by brain imaging during screening.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial.
• People who agree to use reliable contraception (hormonal, barrier methods, or abstinence) before starting the study, throughout participation, and for 6 months after the last dose — this applies to both women who could become pregnant and men.
• During the early dose-testing phase of the trial, people with cancer detectable only in bones or not measurable by scans may be eligible; during the later expansion phase, only people with cancer that can be measured on scans are eligible.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have previously received the chemotherapy drug gemcitabine for their metastatic breast cancer.
• People who have had a platelet transfusion within the 7 days before starting treatment.
• People with a known history of heart problems or prior treatment with heart-damaging medications, unless a heart function assessment places them in a category considered low enough risk (New York Heart Association class 2B or better); people with a history of heart failure must have documented evidence of adequate heart function within the past 12 months.
• People whose heart's electrical activity shows a prolonged interval (called QTc greater than 480 milliseconds) on a screening heart tracing (ECG/EKG).
• People with a known chronic neurological condition — such as multiple sclerosis, Huntington's disease, Parkinson's disease, or uncontrolled epilepsy — that causes movement problems, vision problems, or seizures, as these could make it difficult to assess side effects from the study drug.
• People who are pregnant or breastfeeding, as the study drug may be harmful to a developing baby or infant.
• People who have had a major surgical procedure within the 28 days before joining the trial.
• People who have had an uncontrolled bleeding episode within 28 days before joining the trial.

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