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:

• You must be 18 years of age or older
• You must be well enough to carry out basic daily activities (your doctor will assess this using a standard scale)
• You must have been diagnosed with triple-negative breast cancer (a type of breast cancer that lacks certain hormone receptors), confirmed by a lab test
• Your tumor must test negative for a protein called PD-L1, measured by a specific standard test
• Your cancer must have spread to other parts of the body (metastatic) and be measurable on scans
• You must have at least one area of cancer that a doctor could safely take a small tissue sample (biopsy) from during the study
• You must not have received any prior immunotherapy treatments for your metastatic cancer
• You may have received certain approved antibody-based cancer drugs (antibody drug conjugates) previously
• Your doctor must consider you a suitable candidate for standard chemotherapy
• You may have had chemotherapy before your cancer spread (before or after surgery)
• At least 14 days must have passed since your last cancer treatment or radiation therapy aimed at relieving symptoms
• You may continue taking bone-strengthening medications (such as bisphosphonates or denosumab) during the study
• You must not have taken steroid medications (other than those given alongside chemotherapy or to prevent reactions to contrast dye) for at least 28 days before joining
• You must have recovered from any recent major infections or surgeries, and not have any serious active illnesses that would prevent participation
• You must be willing to have up to two tissue biopsies taken during the study
• Your blood test results must meet specific minimum levels for white blood cells, infection-fighting cells, red blood cells, and platelets (taken within 28 days before your first study vaccine)
• Your liver function test results must be within acceptable ranges (taken within 28 days before your first study vaccine)
• Your kidney function must be within an acceptable range (taken within 28 days before your first study vaccine)
• If you could become pregnant, you must use two forms of contraception and have a negative pregnancy test before starting; male participants who could father a child must use effective barrier contraception throughout the study

Who may not be able to join:

• You have already received more than one round of treatment for your metastatic cancer
• Your tumor tests positive for the PD-L1 protein using the standard test
• You are currently enrolled in another clinical trial that involves a treatment intervention (non-treatment studies such as tissue or biomarker collection are allowed)
• You have certain serious heart conditions, including specific types of heart muscle disease, unstable chest pain within the last 4 months, severe heart failure currently being treated, or fluid around the heart causing symptoms
• You have an autoimmune disease or other condition that requires you to regularly take steroid tablets or medications that suppress your immune system (inhaled, nasal spray, or skin-applied steroids are allowed)
• You have had a known allergic reaction to a substance called GM-CSF (an immune-boosting ingredient used in the study vaccine), or have any medical reason not to receive it
• You have had another type of cancer (not breast cancer) that needed radiation or systemic treatment within the last 5 years, or you have a type of blood cancer currently being monitored
• You are pregnant or breastfeeding
• You have a known history of HIV, hepatitis B, or hepatitis C infection
• You have had major surgery within 4 weeks before starting the study vaccine
• You have received any other vaccine (including live or non-live vaccines) within 14 days before a study vaccine dose — note: this rule does not apply to the tetanus and diphtheria (Td) vaccine
• You have any condition that your doctor believes would interfere with your ability to participate in the study

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