Phase 3 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 been diagnosed with triple-negative breast cancer (TNBC) that has either spread to other parts of the body or come back in a way that cannot be treated with surgery or with the aim of curing it.
• People who are generally well enough to carry out daily activities with little or no limitation (based on a standard health performance scale).
• People who are able to provide a tumour tissue sample — either a fresh sample taken from the current cancer site, or a stored sample collected within the last 3 years.
• People whose tumour tests positive for a protein called PD-L1 at a certain level (CPS of 10 or higher), confirmed through a specific test at a central laboratory designated by the trial sponsor.
• People who have not previously received chemotherapy or other systemic (whole-body) cancer treatments for their metastatic or returned inoperable breast cancer. People whose cancer has come back must have completed their earlier treatment at least 6 months before the cancer returned.
• People whose cancer can be treated with one of the chemotherapy options allowed in this trial (paclitaxel, nab-paclitaxel, or gemcitabine combined with carboplatin).
• People whose cancer can be measured on scans according to standard criteria (called RECIST 1.1).
• People with adequate blood counts and organ function (such as liver and kidneys) within acceptable ranges.
• People who are willing and able to use the contraception methods specified by the trial, if there is any possibility of pregnancy.

Who may not be able to join:

• People with serious or uncontrolled medical conditions — such as uncontrolled high blood pressure, severe bowel conditions, a history of organ transplant, active bleeding, active serious infections, significant heart conditions, substance use issues, or significant psychiatric or psychological conditions — that the trial doctor believes would make participation unsafe or difficult.
• People with a history of another cancer, unless it was treated with the intent to cure, has shown no signs of returning for at least 2 years before the trial starts, and carries a low risk of coming back.
• People with active cancer that has spread to the spinal cord (unless previously treated) or active brain metastases that are still causing symptoms, still require steroid or anti-seizure medication, or from which the person has not yet recovered in terms of side effects from radiotherapy.
• People with an active uncontrolled infection currently requiring intravenous (IV) antibiotics, antiviral, or antifungal medicines.
• People with active or uncontrolled hepatitis B or hepatitis C infection.
• People with HIV that is not well managed.
• People with uncontrolled or significant heart disease.
• People with a history of lung inflammation (a condition called ILD or pneumonitis, including from radiation) that required steroid treatment, or who currently have or are suspected to have this condition.
• People with severely reduced lung function.
• People with a significant eye (corneal) condition.
• People with active or previously diagnosed autoimmune or inflammatory conditions.
• People who have previously received certain targeted cancer treatments — specifically, treatments directed at a protein called TROP2, or a type of drug called an ADC that contains a topoisomerase I–targeting chemotherapy agent.
• People who are currently receiving any other cancer treatment.
• People with a known serious allergic reaction to the types of drugs used in this trial (PD-1/PD-L1 inhibitors or Dato-DXd).
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the trial period.

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