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:

• Adults aged 18 or older, of any gender.
• People who have been diagnosed with invasive breast cancer (confirmed through a tissue sample) that has not yet been treated.
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or agree to use highly effective contraception (less than 1% chance of failure per year) starting from the first treatment dose through at least 6 months after the last dose. Accepted methods include complete abstinence, a non-hormonal or hormonal IUD (hormonal IUD must be used with a barrier method), surgical sterilisation, or a male partner who has had a confirmed vasectomy.
• Male participants with female partners who could become pregnant must either abstain completely from intercourse, have had a confirmed vasectomy, or use condoms together with their partner using a highly effective contraceptive method — during treatment and for at least 3 months after the last dose.
• People who are generally well enough to carry out daily activities with little or no limitation (assessed using a standard medical scale called ECOG, scored 0 or 1).
• People who are able to understand the study and are willing to sign a consent form before any screening begins, and who are able to follow the study requirements, including a research biopsy.
• People whose blood test results at screening show that bone marrow and organ function are within the required ranges — including adequate levels of white blood cells, platelets, haemoglobin, kidney function, liver function, and blood clotting (confirm specific values with the trial site).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the 6 months before enrolment.
• People with a history of hepatitis B who have been on antiviral treatment for at least 4 weeks and have an undetectable viral load before registering.
• People with a history of hepatitis C who have been treated and cured, or who are currently on treatment with an undetectable viral load.

Who may not be able to join:

• People who are currently receiving, or have received within the past 3 years, systemic (whole-body) treatment for any cancer. (Note: certain hormonal therapies and GnRH medications may be allowed in some settings — confirm with the trial site.)
• People with serious uncontrolled illnesses, such as an active infection, uncontrolled heart failure, unstable chest pain, irregular heart rhythm, or a mental health or personal situation that would make it difficult to follow the study requirements.
• People with significant uncontrolled heart conditions, including a heart attack, chest pain, heart bypass surgery, or inflammation around the heart within the 6 months before joining; or ongoing heart problems such as heart failure, certain abnormal heart rhythms, a very slow heart rate, or abnormal electrical activity in the heart detected on a heart tracing (ECG).
• People with blood pressure that is too high (above 160 mmHg systolic) or too low (below 90 mmHg systolic), though the treating doctor may have some discretion regarding high blood pressure (confirm with trial site).
• Women who are pregnant or breastfeeding, because the safety of the study medications in these situations has not been established.
• People who the study investigator considers are not suitable candidates for the trial for any reason.
• People who have previously had a serious allergic reaction to a drug that is chemically or biologically similar to sacituzumab govitecan (one of the study drugs).

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