Phase 3 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:

• People aged 18 to 70 years old
• People whose overall health and ability to carry out daily activities meets a specific fitness standard used in cancer research (called ECOG performance status 0 or 1 — confirm with trial site if unsure what this means)
• People whose doctors expect them to live for more than 3 months
• People whose breast cancer has been confirmed by a laboratory test to be a specific type called triple-negative breast cancer (TNBC), and more specifically a subtype called LAR, with a particular gene change in the PAM pathway
• People whose breast cancer has come back after earlier treatment or has spread to other parts of the body; if the cancer has returned only in the original area, a doctor must confirm that surgery to fully remove it is not possible
• People who have not yet received any chemotherapy, targeted therapy, or similar treatments for their advanced or metastatic breast cancer
• People who have at least one area of cancer that can be measured or tracked by CT or MRI scan, and that has not previously been treated with radiation
• People whose blood test results and organ function meet specific minimum levels set by the trial (covering blood cell counts, liver function, and kidney function — confirm exact values with trial site)
• People who have not received radiotherapy, hormone therapy, targeted therapy, or surgery within the 3 weeks before starting the trial, and who have fully recovered from any side effects of past treatment; people must also have no nerve-related side effects, or only very mild ones
• Women who could become pregnant must agree to use a medically approved form of contraception during the trial and for at least 3 months after the last dose of the study drug
• People who are willing to sign a consent form, follow the trial requirements, and attend follow-up appointments

Who may not be able to join:

• People who have cancer that has spread to the brain or spinal cord, or who have a history of this
• People with a significant or uncontrolled heart condition, including heart failure, chest pain (angina), a heart attack in the past 6 months, or serious irregular heartbeat
• People who still have ongoing side effects (grade 1 or higher) from previous cancer treatment, with some exceptions such as hair loss (confirm with trial site)
• People who had major surgery within 3 weeks before starting the trial (minor procedures such as fitting a port or line for medication are generally excluded from this rule)
• People who are pregnant or breastfeeding
• People who have had another cancer in the past 5 years, except for certain cured skin cancers or early-stage cervical cancer that has been fully treated
• People who have difficulty swallowing, ongoing diarrhoea, or a bowel blockage that could affect how the body absorbs the study drug
• People with significant fluid build-up in body cavities (such as around the lungs or in the abdomen) that cannot be controlled by drainage
• People who have taken part in another clinical trial of an anti-cancer drug within the 4 weeks before starting this trial
• People with wounds that have not healed over a long period, or fractures that have not fully healed
• People with an active Hepatitis B or Hepatitis C infection, or Hepatitis B with abnormal liver function
• People with known allergies to any of the components of the study drugs, or a history of allergic reactions to similar antibody-based medicines
• People whom the trial doctors consider unsuitable for the trial for any other reason

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