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 triple-negative metastatic breast cancer (a specific type of breast cancer that tests negative for certain hormone receptors and a protein called HER2), confirmed by a tissue or cell sample test at the enrolling hospital.
• People whose cancer has spread or come back and cannot be cured by surgery or other treatments, and who have received no more than 2 previous treatment courses for advanced or metastatic disease.
• People who have previously been treated with specific chemotherapy drugs called anthracyclines and taxanes (in early or advanced treatment stages) and whose doctor considers them a suitable candidate for a drug called eribulin — or people who were not able to receive those chemotherapy drugs for medical reasons, or people whose cancer was already metastatic (spread) when first diagnosed.
• People who show signs of metabolic dysfunction, meaning either a blood sugar marker called HbA1c above 5.5, or a body mass index (BMI) of 30 or higher (a measure of body weight relative to height).
• People who have measurable cancer that can be tracked on scans, or at least one bone lesion of a specific type visible on imaging.
• People who are generally well enough to carry out daily activities with no or minimal limitations, based on a standard medical scoring system (confirm with trial site).
• People aged 18 or older at the time of signing the consent form, who are willing and able to provide written consent before any study activities begin.
• People whose blood test results show their bone marrow, liver, kidneys, and other organs are functioning well enough to meet specific laboratory standards set by the trial (confirm with trial site for exact values).
• People who, in their treating doctor's opinion, are willing and able to follow all study requirements, including fasting (not eating or drinking) before certain treatment days.
• Women who could become pregnant and are sexually active, who are willing to use an approved form of contraception during the trial — including hormonal methods (pill, patch, or vaginal ring), hormonal injections or implants, an intrauterine device (IUD or IUS), both fallopian tubes being blocked, a partner with a confirmed vasectomy, or complete abstinence from heterosexual intercourse.
• Men who are sexually active and willing to use barrier contraception such as condoms.

Who may not be able to join:

• People who have already had three or more lines of treatment for metastatic triple-negative breast cancer.
• People who have a primary brain tumour, cancer that has spread to the brain, or other active brain or nervous system conditions, as determined by the treating doctor.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People with a BMI below 18.5 (considered underweight by standard medical measures).
• People who have a known allergy or severe sensitivity to either of the study drugs (SDX-7320 or eribulin).
• People who have been diagnosed with Type 1 diabetes, or Type 2 diabetes that is not well controlled or requires insulin — where "not well controlled" means a fasting blood sugar above 140 mg/dL and/or an HbA1c of 8% or higher.
• People currently taking more than one blood sugar-lowering medication (a single stable dose of metformin taken for at least 3 months before joining may be acceptable — confirm with trial site).
• People who have or have had another cancer within the past 3 years, with the exception of certain treated skin cancers or cervical cancer that was fully removed.
• People with HIV infection that is not well controlled (testing is not required to join the trial).
• People with active and uncontrolled Hepatitis B or Hepatitis C infection.
• People who have had a severe skin reaction to a medication in the past, such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, or erythema multiforme.
• People with any other serious uncontrolled medical condition that the treating doctor believes would make participation unsafe (confirm with trial site).
• People with significant heart problems or recent cardiac events, including any of the following:
  • Chest pain (angina), heart bypass surgery, inflamed lining around the heart, or a heart attack within the past 6 months.
  • A history of moderate to severe heart failure (based on a standard medical classification system).
  • A diagnosed condition affecting the heart muscle (cardiomyopathy).
  • Reduced heart pumping strength below 45%, measured by a heart scan.
  • Certain heart rhythm problems or electrical conduction abnormalities in the past 12 months (confirm with trial site for specific types).
  • Uncontrolled high blood pressure, meaning a reading at or above 160/100 mmHg, even with blood pressure medication.
  • A condition called Long QT syndrome, a family history of sudden unexplained death or inherited Long QT syndrome, or related risk factors including certain electrolyte imbalances, a history of heart failure, or a very slow heart rate — or currently taking medications known to affect heart rhythm in a way that cannot be stopped or substituted.
  • A resting heart rate below 50 beats per minute, confirmed by heart tracing (ECG) or pulse check.
  • A heart tracing (ECG) that cannot be read properly, or a specific heart interval measurement (QTcF) that is too long — above 450 milliseconds for men or 470 milliseconds for women.
• People currently taking medications known to affect heart rhythm in a dangerous way that cannot be stopped at least 7 days before starting the trial, or herbal supplements (with the exception of cannabinoids and CBD products).
• People who have taken part in another experimental study within 14 days before starting this trial, or within 5 half-lives of the experimental drug used, whichever is the longer period.
• People who have had a severe episode of pancreatitis (inflammation of the pancreas) within the past year, or who have a history of long-term chronic pancreatitis.
• People who are pregnant.

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