Phase 3 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:

• Women aged 18 or older
• People diagnosed with breast cancer that has spread to nearby tissue or to other parts of the body, confirmed by a tissue or cell sample
• People whose breast cancer has tested negative for HER2 (a specific protein) in both the original tumour and any re-tested spread sites
• People who are generally well enough to carry out daily activities with little or no limitation (based on a standard fitness scale scored 0 or 1)
• People whose cancer can be tracked on scans — either with at least one measurable area of disease, or with bone-only spread that can be assessed by bone scan, PET, or MRI
• People who previously received a chemotherapy type called a taxane for early-stage breast cancer, as long as that treatment finished at least 12 months before joining the trial
• People who have not yet received chemotherapy for advanced or metastatic breast cancer
• People with hormone receptor-positive (HR+) breast cancer whose disease came back or worsened within 2 years of hormonal therapy after surgery, OR who have already received at least one hormonal therapy since the cancer spread
• People whose side effects from any previous cancer treatment have largely resolved to a mild level or better (hair loss is an exception and does not disqualify someone)
• People with brain metastases that are not causing symptoms, under specific conditions regarding whether other measurable disease exists outside the brain (confirm with trial site)
• People with adequate blood counts and liver and kidney function
• Women who could become pregnant must agree to use contraception throughout treatment and for at least 90 days after the last dose
• People with a life expectancy of at least 12 weeks
• People who are able to attend appointments and follow the study schedule

Who may not be able to join:

• People whose breast cancer tests HER2-positive
• People who have had another cancer in the past 5 years, with the exception of certain cured skin cancers or early-stage cervical changes
• People who have received any anti-cancer treatment — including chemotherapy, radiation, biological therapy, immunotherapy, or certain traditional medicines — within 4 weeks before starting the study
• People who have had major surgery or a serious injury within 4 weeks before the first dose, or who are expected to need major surgery during the study
• People who previously experienced severe (grade 3 or higher) nervous system side effects from a type of chemotherapy that works on cell structure (anti-microtubule drugs)
• People with brain metastases that are causing symptoms
• People who are pregnant or breastfeeding
• People with a known or suspected allergy to any of the study medications or their ingredients
• People with significant non-cancer health conditions affecting the heart, kidneys, liver, or other organs that would make treatment or follow-up unsafe
• People currently using corticosteroid medications (a type of steroid)
• People whom the trial doctor considers unsuitable for any other reason

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