Phase 2 Liver 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 (cancer that has spread beyond the breast), confirmed by a tissue sample analysis.
• People whose breast cancer tests negative for a protein called HER2 (including a type called triple negative breast cancer).
• People with hormone receptor-positive breast cancer whose disease has continued to grow after treatment with hormone therapies and a specific class of targeted drugs called CDK 4/6 inhibitors, or who could not tolerate those treatments.
• People who have previously been treated with certain newer antibody-drug treatments (called ADCs, such as sacituzumab govitecan or trastuzumab deruxtecan), or whose disease progressed on them — or, in countries where those treatments are not routinely available, people who have tried at least two standard chemotherapy regimens.
• People whose treating doctor considers them suitable for a single chemotherapy drug.
• People whose treating doctor considers them suitable for treatment with one of three specific chemotherapy medicines: eribulin, vinorelbine, or capecitabine.
• People whose cancer has spread mainly to the liver, meaning the largest or most life-threatening portion of the cancer is located in the liver.
• People whose cancer involves no more than half of the liver.
• People who have cancer spread outside the liver only in limited areas such as the breast, lungs, other organs, lymph nodes, or skin, with the liver remaining the most life-threatening site.
• People whose liver tumours can be clearly measured using CT or MRI scans, following standard measurement guidelines.
• People who weigh at least 35 kg (approximately 77 pounds).
• People who have had the required body scans (CT of chest, abdomen and pelvis, and MRI of the liver) completed within 28 days before being enrolled in the trial.
• People who are generally well enough to carry out light activity and care for themselves, based on a standard medical fitness scale (ECOG performance status of 0 or 1).

Who may not be able to join:

• People who have previously had certain liver-directed treatments, including chemoembolization, radioembolization, or direct infusion of chemotherapy into the liver's blood supply.
• People with significant high blood pressure in the liver's blood vessels (portal hypertension), including a history of large swollen veins in the oesophagus or stomach.
• People with moderate or severe heart problems, including unstable chest pain, a recent heart attack, worsening heart failure, significant irregular heartbeat, or severe heart valve disease that would make general anaesthesia risky.
• People with significant lung disease that would make it unsafe to have general anaesthesia.
• People with a history of bleeding disorders, brain metastases, or other abnormalities in the brain that could increase the risk of bleeding while on blood-thinning medication.
• People with known swollen veins at risk of bleeding (in the oesophagus or stomach), an active stomach ulcer, or a recent history of coughing up blood.
• People currently being treated for another cancer, or who have had another invasive cancer treated within the past two years (with some exceptions such as certain well-controlled skin cancers or thyroid cancer).
• People showing signs of rapidly worsening disease, such as spinal cord compression, severe increasing pain, increasing need for oxygen, a bone fracture risk, swollen lymph nodes causing pressure, or fluid build-up around the lungs causing symptoms.
• People who are pregnant or breastfeeding.
• People who are capable of becoming pregnant and are unable to use hormonal suppression to prevent menstruation during treatment.
• People who need to take immune-suppressing medications on an ongoing basis (a low daily dose of prednisolone of 10 mg or less may be acceptable — confirm with trial site).
• People who cannot safely stop taking blood-thinning medication temporarily.
• People with an active bacterial infection causing symptoms such as fever or feeling generally unwell.
• People with an active infection, including active Hepatitis B or Hepatitis C (some exceptions may apply for people with certain Hepatitis B markers but no detectable virus — confirm with trial site).
• People with a known severe allergic reaction to iodine-based contrast dye that cannot be managed with antihistamines or steroids.
• People with a known allergy or serious sensitivity to the drug melphalan or the medical device system used to deliver it.
• People with a known latex allergy.
• People with a known serious allergy to heparin (a blood-thinning medication) or a condition called heparin-induced low platelet count.
• People with uncontrolled hormone-related conditions such as poorly controlled diabetes, underactive thyroid, or overactive thyroid.
• People who have received any anti-cancer treatment, radiotherapy, or an experimental treatment within 30 days before being enrolled.
• People who have not yet recovered from significant side effects of previous treatments (minor or stable side effects such as hair loss may be acceptable — confirm with trial site).
• People who have had surgery within 28 days before enrolment, or whose surgical wound has not fully healed.
• People currently being treated for any cancer other than metastatic breast cancer.
• People who are not considered suitable for any of the three chemotherapy options (eribulin, vinorelbine, or capecitabine).
• People whose blood albumin level (a measure of protein in the blood) is below 3.0 g/dL.

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