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 aged 18 or older, of any gender, who have signed and dated a consent form before any study procedures begin.
• People who are generally well enough to carry out daily activities with little or no limitation (based on a standard performance scale used by doctors).
• People who have been confirmed by tissue or cell testing to have breast cancer that has either spread to other parts of the body (metastatic) or is locally advanced and cannot be removed by surgery or treated with curative radiation.
• People whose breast cancer is hormone receptor-positive (HR+) and HER2-negative, based on local laboratory testing.
• People whose cancer has stopped responding to a class of targeted drugs called CDK4/6 inhibitors — meaning the cancer came back during or within 12 months of finishing that treatment (if used early), or progressed during or within 6 months of finishing it (if used for advanced disease).
• People who have received no more than one prior chemotherapy or antibody-drug conjugate (ADC) treatment for metastatic disease.
• People whose cancer has shown signs of getting worse on scans or other tests after their most recent treatment.
• People whose cancer can be measured or assessed on medical imaging according to standard criteria.
• People who have a tumour site that a doctor considers safe to take a biopsy from, and who are able to have three biopsies taken — one before treatment starts, one after about two weeks, and one at the end of treatment.
• People whose blood tests show that their organs (including liver, kidneys, and bone marrow) are functioning within acceptable ranges within 35 days before starting treatment.
• People with an expected survival of at least 16 weeks.
• People who agree to use the contraception methods specified in the study protocol, if applicable.
• People who are able and willing to follow all the requirements of the study.

Who may not be able to join:

• People whose breast cancer is HER2-positive or triple-negative (TNBC).
• People who have had another cancer in the past, unless it was fully treated with no signs of disease for at least 3 years — with some exceptions such as certain low-risk skin cancers, early-stage cervical changes, or certain early-stage uterine cancers (confirm with trial site).
• People who still have unresolved side effects from previous cancer treatments, unless those effects are considered stable and low-risk by the treating doctor (some exceptions may apply — confirm with trial site).
• People who are currently taking part in another clinical trial involving an experimental treatment or device, unless it is an observational study only.
• People who have brain metastases that are causing symptoms and are not under control. People with previously treated brain metastases may still be considered if they meet specific conditions set out in the study protocol (confirm with trial site).
• People with a significant heart condition, such as severe heart failure, a recent heart attack or unstable chest pain within the past 6 months, serious heart rhythm problems, or a history of a prolonged QT interval on a heart tracing.
• People with active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or who have had a bowel perforation within the past 6 months.
• People with a serious active infection that currently requires intravenous antibiotics, antivirals, or antifungal medicines.
• People with a known history of HIV.
• People with active hepatitis B or hepatitis C infection (some people with prior hepatitis B or C history may still be considered depending on test results — confirm with trial site).
• 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 have received a live vaccine within 30 days before joining the study.
• People who have previously been treated with the drug sacituzumab govitecan.
• People with a known severe allergic reaction (grade 3 or higher) to sacituzumab govitecan or any of its components.
• People who need to take, or have previously taken, any medications listed as prohibited in the study guidelines.
• People who are pregnant (confirmed by a blood test) or currently breastfeeding.

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