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:

• You are between 18 and 75 years old at the time of signing the consent form
• You have been diagnosed with a specific type of breast cancer (hormone receptor-positive, HER2-negative) confirmed by a biopsy or tissue sample
• Your breast cancer cannot be surgically removed, has come back, or has spread, and at least one previous chemotherapy treatment has not worked
• You have at least one area of cancer that can be measured on a scan (skin-only or bone-only disease does not qualify)
• You are generally able to carry out daily activities with little to no limitation (confirm with trial site)
• You are expected to live for at least 12 weeks
• Your organs (such as liver, kidneys) and bone marrow are working well enough (confirm with trial site)
• You are eligible to receive the chemotherapy used in the comparison group of this trial (confirm with trial site)
• If you are a woman who could become pregnant, or a man whose partner could become pregnant, you agree to use effective contraception from signing the consent form until 6 months after your last dose
• You are willing to take part in the study and able to attend all required visits and follow the study procedures

Who may not be able to join:

• You have had cancer spread to your brain or central nervous system, or currently have it
• You have had another cancer (other than certain cured skin cancers or early-stage cervical cancer) within the past 3 years
• You have heart or blood vessel disease, or risk factors for it, that could be affected by the study treatment
• You have a serious ongoing illness that is not well controlled
• You have had or currently have a non-infectious lung condition called interstitial lung disease or pneumonitis that required steroid treatment, or this cannot be ruled out by scans
• You have serious lung damage caused by a lung disease
• You have active inflammatory bowel disease, a blockage in your gut, severe ulcers, a hole in your gut, an abdominal abscess, or serious active gut bleeding
• You still have significant side effects (above a mild level) from a previous cancer treatment
• You have active hepatitis B or hepatitis C
• You have HIV, AIDS, or an active syphilis infection
• You have a known allergy or sensitivity to the study drug (SKB264) or its ingredients
• You have previously been treated with a therapy targeting TROP2, or with a topoisomerase I inhibitor (including certain antibody-drug combination treatments)
• You had major surgery within 4 weeks before starting the study, or are planned to have major surgery during the study
• You had an infection requiring antibiotic treatment within 2 weeks before starting the study
• You received a live vaccine within 30 days before starting the study, or plan to receive one during the study
• You are currently pregnant or breastfeeding

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