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:

• Adults aged 18 or older who are able to understand and sign a written consent form (both men and women are eligible)
• People with a general health status rated as good to fully active (a score of 0 or 1 for the early phase of the study, or 0 to 2 for the later phase — confirm with trial site what these scores mean for your situation)
• People with a life expectancy of at least 3 months
• People who have been diagnosed with metastatic triple-negative breast cancer (a type of breast cancer that tests negative for certain hormone receptors and a protein called HER2), confirmed by laboratory tissue testing
• People who are willing to provide stored tumour tissue samples for research connected to this trial
• People who have already received at least one round of chemotherapy for metastatic triple-negative breast cancer, and/or whose treating doctor has determined them eligible for a medicine called sacituzumab govitecan as a standard treatment option
• People whose cancer can be measured on a CT or MRI scan using standard medical assessment methods
• People with adequately functioning organs such as kidneys, liver, and bone marrow (confirm specific requirements with trial site)

Who may not be able to join:

• People who are pregnant (confirmed by a blood test) or who are currently breastfeeding
• People with a known severe allergic reaction (Grade 3 or higher) to either of the study medicines — naxitamab or sacituzumab govitecan — or their ingredients
• People with moderate to severe nerve damage in their hands or feet (Grade 3 or higher peripheral neuropathy)
• People who have previously been treated with a type of antibody therapy that targets a substance called GD2
• People who have previously received a type of targeted therapy called a TROP2-targeting antibody drug conjugate for metastatic disease — though people who received this type of treatment before surgery or after surgery may still be considered, provided at least 6 months have passed since their last dose
• People who currently have another active cancer — though people with certain low-risk or fully removed cancers (such as some skin cancers or fully excised early-stage cancers) may still be considered
• People with active cancer that has spread to the brain or the lining of the brain and spinal cord
• People who have had an organ or tissue transplant from another person
• People with persistently high blood pressure (above 160 mmHg) that has not been controlled despite medical treatment
• People with significant heart disease (confirm specific details with trial site)
• People with poor lung function (confirm specific details with trial site)
• People with active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), or who have had a hole or tear in their digestive tract within the past 6 months
• People who have had a seizure within the past 3 months despite taking anti-seizure medication
• People with a serious active infection currently requiring antibiotic or antiviral treatment
• People living with HIV who also have a history of certain HIV-related conditions called Kaposi sarcoma or Multicentric Castleman Disease
• People with an active hepatitis B or C infection
• People with a condition affecting the immune system, or who are currently taking immune-suppressing medicines (including corticosteroids above a certain dose) within 14 days before the start of the trial
• People who have received radiation therapy within 1 week before starting the trial

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