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 metastatic breast cancer that has been confirmed by a pathologist to be HER2-negative, based on 2018 testing guidelines.
• People whose metastatic disease has been confirmed by imaging (such as a scan).
• For Groups A and B: People who have either newly diagnosed cancer spread to the brain, or brain metastases that have grown or returned after previous treatment.
• For Groups A and B: People who have had a brain MRI (with and without contrast dye) showing at least one measurable brain tumour spot that is 1.0 cm or larger, which has either not been treated with radiation or has grown despite prior radiation or other treatment. A CT scan with contrast may be used instead of MRI if MRI is not possible and the brain tumours can still be clearly measured.
• For Group C: People who have evidence of cancer spread to the fluid and lining around the brain and spinal cord (called leptomeningeal disease), confirmed by the treating doctor through imaging and clinical assessment — a positive spinal fluid test is not required.
• For Group A: People who have previously received at least one hormonal (endocrine) therapy (with or without a CDK4/6 inhibitor) for metastatic breast cancer, or who experienced cancer returning while on adjuvant (post-surgery) hormonal therapy. There is no limit on the number of prior treatments.
• For Groups B and C: People who have not received any prior treatment, as well as those who have had previous treatments — there is no limit on the number of prior treatments.
• People who may or may not have cancer spread outside the brain, but must have imaging done to check on disease status at the start of the trial.
• People aged 18 or older.
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2).
• People who have waited an appropriate amount of time since their last treatment before joining — for example, more than 4 weeks after major surgery, more than 2 weeks after radiation, and varying waiting periods depending on the type of chemotherapy or other therapy received (confirm specific timeframes with the trial site). No waiting period is needed for hormonal therapies, though these should be stopped before starting the trial.
• People whose heart is pumping well enough, with a heart function measurement (LVEF) of at least 50% on a heart scan.
• People whose blood test results meet required levels, including sufficient red blood cells, white blood cells, and platelets, as well as acceptable liver and kidney function values (confirm specific numbers with the trial site). Blood or platelet transfusions must not have been given within 1 week before these tests.
• People with a history of HIV, Hepatitis B, or Hepatitis C may be considered on a case-by-case basis; testing for these conditions is not required at the start of the trial.
• Women who could become pregnant must have a negative pregnancy test within 14 days of starting the trial.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People experiencing a serious, life-threatening organ crisis, or one that is about to occur.
• People who urgently need brain surgery, such as tumour removal or placement of a fluid-draining device.
• People who need immediate local treatment (such as radiation or surgery) to a brain tumour, based on local medical standards.
• People who show signs of significant bleeding in the brain causing symptoms.
• People who have had more than 2 seizures in the 4 weeks before joining the trial.
• People who still have ongoing side effects from previous cancer treatment (other than hair loss) that have not improved to a mild level or returned to their pre-treatment state.
• People who cannot have an MRI for medical reasons (such as having a pacemaker, certain metal implants, severe claustrophobia, or an allergy to contrast dye) — though for Groups A and B, a CT scan with contrast may be accepted instead if the brain tumours can be clearly measured that way.
• People who are receiving other cancer treatments at the same time as this trial (supportive care medications are allowed).
• People with serious uncontrolled health conditions, including but not limited to: active serious infection, severely reduced lung function, unstable chest pain (angina), uncontrolled irregular heart rhythm, active heart disease, a heart attack in the past 6 months, a stomach or small intestinal ulcer diagnosed in the past 6 months, chronic liver or kidney disease, or severe malnutrition. People with diabetes who are unable to monitor their own blood sugar levels at home are also not eligible.
• People who require ongoing high-dose steroid medication (more than 4 mg of dexamethasone per day, or an equivalent dose of another steroid) or other immune-suppressing medications within 7 days before the baseline brain scan. Steroid doses must be stable and planned to remain at or below this level throughout the trial. However, steroids for managing symptoms may be permitted at the treating doctor's discretion.
• People who have a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, currently have this condition, or have possible lung inflammation that cannot be ruled out by scans at the start of the trial.
• People with a history of uncontrolled seizures, nervous system disorders, or significant mental health conditions that the trial doctor believes would affect safe participation.
• People with a history of a different cancer, except: adequately treated non-melanoma skin cancer, cancer confined to one area that was fully treated (in situ disease), or another solid tumour that was fully treated with no evidence of disease for 3 or more years.
• People who have had major surgery, a significant biopsy, or a serious injury within 28 days before starting the trial, or who are expected to need major surgery during the trial.
• People with significant corneal (eye surface) disease.
• People who have had a serious allergic reaction to the study drug (datopotamab deruxtecan) or any of its ingredients, including polysorbate 80.
• People who have had a serious allergic reaction to other similar antibody-based medicines.
• Women who are pregnant or breastfeeding, as the study drug may harm an unborn baby or infant.
• Women who could become pregnant must agree to use highly effective contraception throughout the entire treatment period and for at least 7 months after the last dose of the study drug, and must not donate or retrieve eggs during this time or for 7 months after the last dose.
• Women must not breastfeed while on the study or for at least 7 months after the last dose of the study drug.
• Men who may father a child must use an effective method of contraception from the time of screening throughout the study and for at least 4 months after the last dose of the study drug, and must not donate or bank sperm during this same period.

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