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:

• Women between 18 and 70 years old
• People who have signed a consent form agreeing to take part in the study
• People who have already received at least 2 previous lines of treatment for their cancer
• People whose breast cancer has been confirmed by a tissue or cell sample test, and is HER2-negative, and has either spread to nearby areas or to other parts of the body
• People whose HER2-negative breast cancer has stopped responding to previous treatment with taxane or anthracycline chemotherapy, or — for those whose cancer is also hormone receptor-positive — people whose cancer has progressed after at least one hormone-based therapy
• People who are reasonably active and able to care for themselves, with a general health score of 0–2 on a standard scale used by doctors, and a life expectancy of at least 3 months
• People who have at least one measurable area of cancer that can be tracked during the trial
• People with adequate blood counts and liver and kidney function
• People whose side effects from previous cancer treatments have largely settled down to a mild level or better
• Women of childbearing potential who agree to use highly effective contraception during the study and for 6 months after the last dose, are not breastfeeding, and have a negative pregnancy test within 7 days before joining

Who may not be able to join:

• People whose cancer got worse while previously being treated with bevacizumab
• People who have previously used a drug called Utidelone within the last 6 months
• People who have had radiotherapy or chemotherapy within the last 3 weeks, or hormone therapy within the last 1 week
• People who have had significant coughing up of blood (more than 50 ml per day) in the 3 months before joining, or who have active or significant bleeding problems, gastrointestinal bleeding, bleeding stomach ulcers, or a condition called vasculitis
• People who have had a blood clot event in the 6 months before joining, such as a stroke, mini-stroke (TIA), deep vein thrombosis (with some exceptions at the investigator's discretion), or pulmonary embolism
• People with poorly controlled high blood pressure (above 140/90 mmHg), or who have had a heart attack, severe chest pain, significant heart rhythm problems, or heart failure within the 6 months before joining
• People with lung conditions such as interstitial lung disease, active inflammation of the lungs, or uncontrolled conditions such as diabetes or pulmonary fibrosis
• People whose urine or kidney tests show significant levels of protein in the urine, suggesting reduced kidney function
• People who have received a live attenuated vaccine (a type of weakened-virus vaccine) within 28 days before the first dose, or who expect to receive one during the trial
• People with HIV infection or AIDS, or active hepatitis B or C infection (confirm with trial site for specific test thresholds)
• People who have had a serious infection requiring hospitalisation within 4 weeks before joining, an active infection requiring antibiotics within 2 weeks before the first dose, an unexplained fever above 38.5°C during screening, or evidence of active tuberculosis within the past year
• People who have been diagnosed with another cancer within the past 3 years
• People who have had major surgery within 28 days, or minor surgery within 14 days, before joining
• People who have previously had, or are planned to have, a bone marrow transplant or solid organ transplant
• People with moderate or severe nerve damage in their hands or feet (peripheral neuropathy grade 2 or above), or active cancer spread to the brain or the lining of the brain or spinal cord (though people with previously treated and stable brain metastases may be considered — confirm with trial site)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with other serious physical or mental health conditions, or abnormal test results, that the trial doctor considers would make participation unsafe or affect the trial results

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