Phase 2 Brain 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 breast cancer confirmed by laboratory testing of tissue samples
• People whose breast cancer is "triple-negative," meaning the cancer tests negative for oestrogen receptors, progesterone receptors, and HER2 protein (less than 10% of tumour cells show positive staining for hormone receptors)
• People who have newly diagnosed cancer that has spread to the brain and has not yet been treated, or whose brain metastases have continued to grow after previous local treatment
• People whose disease can be measured using standard brain tumour imaging criteria (RANO-BM)
• People for whom immediate local treatment of brain metastases is not required
• People who also have a related condition called type II leptomeningeal disease (cancer affecting the lining of the brain/spinal cord), confirmed by clinical findings and imaging
• People with a general health and function score of KPS 70% or higher, or ECOG score of 2 or lower
• People who have a medical need for systemic (whole-body) cancer treatment
• People who have previously received certain immunotherapy drugs (PD-1 or PD-L1 inhibitors) or TROP-2 targeted treatments
• People with a life expectancy of at least 3 months
• People aged 18 years or older
• People who are physically able to tolerate the study treatment
• People with adequate bone marrow, liver, and kidney function
• People who have completed an appropriate waiting period after their most recent treatment before enrolling, as follows: at least 3 weeks after major surgery; at least 4 weeks after radiation therapy to the chest; at least 2 weeks after palliative radiation to other areas; at least 3 weeks after chemotherapy or small-molecule targeted therapy; at least 4 weeks after antibody-based treatment (treatment with denosumab may continue)
• People who understand the purpose of the study and have provided written consent to participate

Who may not be able to join:

• People with a known allergic reaction to the study drug (Dato-DXd) or any of its ingredients
• People who have taken another experimental drug within 28 days before starting this trial
• People who have had another type of cancer within the last 3 years, other than certain skin cancers (squamous cell or basal cell carcinoma) or early-stage cervical cancer, including cancer in the other breast
• People currently receiving any other cancer treatment, such as chemotherapy, targeted therapy, immunotherapy, hormonal cancer treatment, or antibody therapy (bone-strengthening treatments like denosumab or bisphosphonates are allowed)
• People currently receiving radiotherapy at the same time as the trial
• People with a history of uncontrolled seizures, significant nervous system disorders, or psychiatric conditions that the trial doctor considers would interfere with safe participation
• People with serious heart conditions, including unstable angina, a heart attack within the past 6 months, severe heart failure, a heart pumping function below 50%, uncontrolled irregular heartbeat, or a specific abnormal heart rhythm measurement (QTc interval above 470 ms)
• People with inadequate bone marrow function at the start of the trial
• People with inadequate kidney function
• People with active liver or bile duct disease (some exceptions apply, including Gilbert's syndrome, symptom-free gallstones, liver metastases, or stable chronic liver disease — confirm with trial site)
• People with known hepatitis B or C infections may still be considered eligible under specific conditions relating to viral load, liver enzyme levels, vaccination history, and antiviral treatment — confirm exact requirements with the trial site
• People with serious lung problems caused by other illnesses
• People who have a history of non-infectious lung inflammation (ILD/pneumonitis) that required steroid treatment, or who currently have or are suspected to have this condition
• People with active opportunistic infections (serious infections that occur due to a weakened immune system)
• People with HIV infection that is not well managed
• People who are pregnant or breastfeeding
• Women who could become pregnant and are unwilling or unable to use adequate contraception from the start of the trial until one year after the last dose of treatment
• Men who are unwilling or unable to use adequate contraception during the trial
• People with known substance abuse or other medical or psychological conditions that the trial doctor believes would interfere with safe participation
• People requiring ongoing high-dose steroid treatment (more than 8 mg of dexamethasone per day by mouth or injection), or other immune-suppressing medications, except when used to manage side effects (inhaled steroids or steroid injections into joints are permitted)
• People with significant corneal disease affecting the eyes

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