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 who have been diagnosed with breast cancer that cannot be surgically removed, has spread locally, or has spread to other parts of the body (metastatic), confirmed by a tissue test.
• Men and premenopausal women who have been on hormone-suppressing injections (LHRH agonist) for at least four weeks before starting the trial, and who agree to continue these injections throughout the trial.
• People whose breast cancer tests positive for estrogen receptors (ER+) and negative for HER2, as determined by standard medical guidelines.
• People whose cancer has gotten worse after at least one previous hormone-based treatment used together with a CDK 4/6 inhibitor. Previous treatment with fulvestrant is also permitted.
• People who have received no more than two rounds of chemotherapy for their metastatic cancer.
• People who have brain metastases that were previously treated and have been stable (no signs of growth on scans) for at least four weeks, are not causing symptoms requiring steroid medication, and are confirmed stable by repeat imaging during screening.
• People who are expected to live for at least 12 weeks.
• People who can provide a fresh tumour biopsy before the first dose; those whose tumour cannot be safely biopsied may be considered if tumour tissue from within the past 6–12 months is available (confirm with trial site).
• People who provide written consent to participate in the trial.
• People who have at least one area of cancer that can be measured on scans, according to standard criteria (RECIST 1.1).
• People with a general health and activity level rated 0 or 1 on a standard medical scale (ECOG), assessed within seven days before the first dose.
• People whose blood pressure is adequately controlled at or below 150/90 mmHg, with no change in blood pressure medication in the week before joining.
• People whose blood counts, kidney, liver, and clotting function are within acceptable ranges, confirmed by blood tests taken within 14 days before starting.
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or who are using a highly effective contraceptive method (or are consistently and long-term abstinent), throughout the treatment period and for at least 120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, whichever is later.
• Women who could potentially become pregnant must have a negative pregnancy test within 72 hours before the first dose.
• Men who agree to use a condom (plus their partner using an additional contraceptive method) or who are consistently and long-term abstinent, during treatment and for at least 7 days after the last dose of lenvatinib.
• People with a history of Hepatitis B who have been on antiviral treatment for at least four weeks and have an undetectable viral load before joining, and who agree to remain on antiviral therapy during the trial.
• People with a history of Hepatitis C who have completed curative antiviral treatment at least four weeks before joining and have an undetectable viral load at screening.

Who may not be able to join:

• People who have previously received certain immunotherapy drugs that work on the PD-1, PD-L1, PD-L2, CTLA-4, or related immune pathways.
• People who have previously received lenvatinib or any other drug that targets tumour blood vessel growth (anti-angiogenic therapy).
• People who have received any systemic cancer treatment within two weeks before joining, unless all significant side effects from that treatment have resolved.
• People who have received radiotherapy within two weeks before joining (one week for limited palliative radiation to non-brain areas), or who still have significant side effects from radiation.
• People who have received a live or live-attenuated vaccine within 30 days before the first dose.
• People currently participating in, or who have recently participated in, another clinical trial or used an investigational device within two weeks before the first dose.
• People with immune system deficiency, or who are taking steroid medication at doses above 10 mg of prednisone (or equivalent) per day, or other immune-suppressing medications, within seven days before the first dose. Inhaled, nasal, joint-injected, or topical steroids are permitted.
• People who have another cancer that is currently active or has required treatment within the past three years (certain skin cancers that have been successfully treated are exceptions).
• People with active, untreated cancer spread to the brain or the lining of the brain, unless previously treated brain metastases meet the stability criteria described above.
• People with a history or current evidence of active lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People who currently have an active infection requiring antibiotic treatment.
• People with a known history of HIV infection.
• People who are unable to swallow capsules.
• People with significant psychiatric conditions or substance use disorders that would interfere with trial participation.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period or within 120 days after the last dose.
• People who have had an organ or tissue transplant from another person.
• People with conditions affecting how the gut absorbs medication, which could affect how lenvatinib works in the body.
• People who have had clinically significant coughing up of blood or tumour bleeding within two weeks before the first dose.
• People who have had significant heart problems within the past 12 months, such as serious heart failure, unstable chest pain, heart attack, stroke, or an irregular heart rhythm causing instability (medically controlled arrhythmia is permitted).
• People whose heart pumping function (left ventricular ejection fraction) is below the normal institutional threshold of 50%, as measured by heart scan.
• People with a significantly prolonged heart electrical interval (QTcF above 480 ms) on an ECG (confirm with trial site if a pacemaker is present).
• People with significant blood vessel problems such as a large artery aneurysm requiring surgery, or arterial blood clots (a history of deep vein thrombosis in veins is permitted).
• People with an active autoimmune disease (other than psoriasis) that has needed systemic medical treatment in the past two years. Hormone replacement therapies for conditions such as thyroid or adrenal deficiency are not considered systemic treatment for this purpose.
• People with a known intolerance or allergy to any of the study drugs or their ingredients.
• People who have had major surgery within three weeks before the first dose, or whose surgical wounds have not adequately healed.
• People with a pre-existing severe fistula (an abnormal connection or opening in tissue) rated Grade 3 or higher.
• People with high levels of protein in their urine (1 gram or more per 24 hours).
• People whose scans show that a major blood vessel is surrounded or invaded by tumour, or that there are cavities forming inside the tumour.

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