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 have signed a consent form before taking part in any study-related activities.
• People aged 19 years or older at the time of signing the consent form.
• People whose general health and ability to carry out daily activities meets a specific standard (rated 0 or 1 on a medical scale called ECOG — confirm with trial site what this means for a specific situation).
• People with a life expectancy of at least 12 weeks.
• People whose breast cancer has been confirmed by a tissue sample (biopsy) to be triple-negative breast cancer (TNBC), meaning the cancer does not have significant levels of oestrogen receptors, progesterone receptors, or HER2 protein.
• People whose cancer has spread to other parts of the body (metastatic disease), confirmed by CT scan or MRI, and cannot be removed by surgery with the aim of a cure.
• People whose cancer has stopped responding to at least one, but no more than two, prior standard chemotherapy treatments for advanced or metastatic breast cancer (a type of targeted drug called a PARP inhibitor may count as one of these prior treatments).
• People who have previously been treated with a type of chemotherapy called taxanes at some point during their cancer treatment (unless taxanes were not medically appropriate for them).
• People who have measurable or assessable disease as determined by standard imaging guidelines, including those with cancer that has spread only to the bones.
• People with stable brain metastases (cancer that has spread to the brain) that have been treated, with no neurological symptoms, and who have been off certain medications (anti-seizure drugs and steroids above a low threshold) for at least 2 weeks before starting the study drug — a brain MRI is required if brain metastases are suspected.
• People whose blood test results for organ function fall within acceptable ranges set by the trial, including measures of blood cell counts, liver function, kidney function, and blood clotting (confirm with trial site for specific values).
• People who have recovered from side effects of previous cancer treatments to a mild level (Grade 1 or better), except for hair loss or other side effects the doctor considers low risk.
• People who agree to use specified contraception methods during treatment and for 6 months after the last dose — specific methods are required for both women of childbearing potential and men (confirm with trial site for details).
• People who have finished all prior cancer treatments at least 2 weeks before the first study drug infusion (or at least 4 weeks for prior biological cancer therapies), including chemotherapy, hormone therapy, radiotherapy, and major surgery.

Who may not be able to join:

• People who have previously been treated with a type of drug called a topoisomerase 1 inhibitor, in any form.
• People who have previously received a treatment called a Trop-2-directed antibody-drug conjugate (ADC).
• People whose cancer has spread to the membranes surrounding the brain and spinal cord (carcinomatous meningitis).
• People with a known serious allergic reaction to any of the study drugs or their ingredients.
• People who are HIV-positive and have a history of certain HIV-related conditions (Kaposi sarcoma or Multicentric Castleman Disease).
• People with active hepatitis B (HBV) or hepatitis C (HCV) infection, or a history of these infections with detectable virus levels in the blood — some people with a past hepatitis B infection but no active virus may still be considered eligible under certain monitoring or treatment conditions (confirm with trial site).
• People who have planned surgery during the study, except for minor procedures that would not delay the study drug (such as short procedures under local or sedation anaesthesia).
• People who currently have a second active cancer — people whose previous cancer has been fully treated with no signs of active cancer for at least 3 years, or people with certain low-risk surgically treated cancers, may still be considered eligible.
• People with a known history of significant bleeding, bowel obstruction, or a hole in the gastrointestinal tract within the past 6 months.
• People with active or previously documented inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, or any pre-existing condition that causes ongoing diarrhoea.
• People who needed antibiotic treatment for an infection within 1 week before the first study drug infusion.
• People with other medical or mental health conditions that, in the doctor's opinion, could interfere with the study or make it unsafe to participate.
• People who are pregnant or breastfeeding.
• People currently taking part in another clinical trial that involves a treatment intervention (participation in observational studies is acceptable).
• People with any medical condition that, in the opinion of the investigator or study sponsor, poses an unacceptable risk.
• People who have taken other experimental drugs (not approved for any use) within 28 days or 5 half-lives of the first study dose, whichever is longer.

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