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 are able to understand and voluntarily sign a consent form agreeing to take part in the study.
• People with a good general health and activity level, scored as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People with a life expectancy of more than 3 months.
• People who have been confirmed by tissue or cell testing to have metastatic breast cancer that is triple-negative (meaning the cancer tests negative for hormone receptors and a protein called HER2), based on specific laboratory results.
• People whose cancer has stopped responding to at least two previous standard treatments for metastatic disease. For triple-negative breast cancer (TNBC) with a specific immune marker (PD-L1 positive with a score of 10 or above), prior treatment must have included chemotherapy combined with a type of immunotherapy (PD-1 treatment). TNBC patients with a known inherited BRCA gene mutation who the treating doctor has determined cannot receive a specific type of targeted therapy (PARP inhibitors) may also be eligible. Cancer that comes back within 12 months of completing TNBC adjuvant (post-surgery) treatment counts as a first-line treatment for this purpose.
• People who the treating doctor considers suitable for one of the following chemotherapy medicines: Eribulin, Gemcitabine, Utidelone, or Vinorelbine.
• People who have at least one tumour that can be measured by CT or MRI scan, following standard measurement guidelines. At least one tumour area must not have previously been treated with radiotherapy and must meet minimum size requirements. People with bone-only spread or stable brain spread may also be eligible.
• People with adequate blood counts and organ function, including sufficient red blood cells, white blood cells, and platelets, as well as liver and other organ function within acceptable ranges based on blood test results.
• Women who are pre-menopausal and willing to use medically accepted contraception during the study.
• People who are likely to follow the study schedule and requirements consistently.

Who may not be able to join:

• People with uncontrolled high blood pressure or ongoing active infections.
• People still experiencing significant side effects from previous cancer treatments (other than hair loss) that have not improved to a mild level or returned to their normal baseline — for example, hearing loss, nerve problems, or immune-related conditions such as thyroid problems, high blood sugar, or adrenal gland issues.
• People with spinal cord compression caused by the tumour, or brain metastases that are currently active and unstable.
• People with significant fluid build-up in body cavities, such as in the abdomen or around the lungs, that the treating doctor considers unsuitable for study participation.
• People with uncontrolled infections currently requiring intravenous antibiotics, antiviral, or antifungal treatment.
• People who are known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• People with serious or uncontrolled heart conditions, including a heart attack or unstable chest pain within the last six months, heart failure, severe irregular heart rhythms, or very high blood pressure that cannot be controlled.
• People with suspected lung inflammation (a condition called interstitial lung disease or non-infectious pneumonia) that cannot be ruled out and requires steroid treatment.
• People with active autoimmune or inflammatory conditions, such as inflammatory bowel disease, lupus, rheumatoid arthritis, or autoimmune conditions affecting the lungs or heart, among others.
• People currently receiving any other cancer treatments at the same time.
• People who the treating doctor believes are unlikely to follow the study procedures and requirements.

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