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:

• People who have been diagnosed through a biopsy with triple negative breast cancer that has spread to other parts of the body (metastatic), with at least 2 measurable areas of spread visible on scans, and whose cancer tests negative for estrogen receptors, progesterone receptors, and HER2 protein by specific laboratory definitions
• People whose cancer tests positive for a protein called PD-L1, measured using a specific test (Dako 22c3 assay) with a score of 10 or higher
• People who have had a recent physical examination (within the past 60 days) and appropriate scans confirming the spread of cancer, completed within 4 weeks before starting radiotherapy on this trial
• People whose treating doctor has determined them suitable for radiotherapy
• People whose treating doctor has determined them suitable for immunotherapy and a type of chemotherapy called taxane
• People who have at least one area of cancer spread that is able to receive high-dose radiotherapy
• People aged 18 years or older
• People with a general health and activity level within an acceptable range, as measured by standard medical scoring tools (ECOG performance status 0–2, or Karnofsky score of 60% or above)
• People who have measurable cancer according to standard medical imaging criteria (RECIST version 1.1)
• People whose recent blood test results (within 14 days before first treatment) show blood cell counts and organ function within the required ranges, including adequate white blood cells, platelets, haemoglobin, liver enzymes, bilirubin, and kidney function
• People with a known liver condition called Gilbert's disease may still be eligible if their bilirubin level meets a specified threshold (confirm with trial site)
• People who are willing and able to sign a written consent form agreeing to participate in the trial
• People who may or may not have previously received radiotherapy, or chemotherapy given before or after surgery, for early-stage (non-metastatic) breast cancer, provided side effects have resolved sufficiently and enough time has passed since those treatments
• People who previously received immunotherapy for early-stage breast cancer, provided the cancer came back at least 6 months after the last immunotherapy dose
• People who have had surgery and have no active wound healing problems, as assessed by their doctor
• People who have previously received bone-protecting medications called bisphosphonates or RANK-L inhibitors before joining the trial
• Women of childbearing potential who have a negative pregnancy test within 14 days before radiation planning

Who may not be able to join:

• People who have already received chemotherapy or targeted therapy specifically to treat their metastatic triple negative breast cancer (prior chemotherapy for early-stage curative treatment completed more than 6 months before joining may be acceptable — confirm with trial site)
• People who have previously had radiation treatment to the same cancer sites that would be treated under this trial
• People with untreated brain or central nervous system (CNS) cancer spread (people with stable, treated CNS disease that has been symptom-free for at least 28 days may be eligible — confirm with trial site)
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen (those with drainage tubes already in place may still be eligible — confirm with trial site)
• People with uncontrolled high calcium levels in the blood, or symptoms of high calcium requiring ongoing treatment with bisphosphonates or denosumab
• People with a history of an autoimmune disease that has required systemic medical treatment (replacement hormone therapies such as thyroid medication or insulin are not considered systemic treatment in this context)
• People who are currently taking long-term high-dose steroid or immune-suppressing medications at the time of joining (specifically, prednisone or equivalent at more than 10mg per day for more than 2 weeks)
• People who have previously had a stem cell transplant from a donor or a solid organ transplant
• People with serious active health conditions such as heart failure or unstable chest pain within the past 6 months, or a heart attack within the past 6 months
• People with an active bacterial or fungal infection requiring intravenous antibiotics at the time of joining
• People with a history of certain lung conditions including idiopathic pulmonary fibrosis, drug-induced lung inflammation, or organizing pneumonia, or who show active lung inflammation on a recent chest scan (a history of radiation-related lung scarring within the treated area is permitted)
• People with chronic lung disease (such as COPD) or other breathing problems that required a hospital stay at the time of joining
• People who are HIV positive with a CD4 immune cell count below 200 cells per microlitre
• People with another cancer that is currently growing or requires active treatment (certain exceptions apply for some low-risk or non-invasive skin cancers or slow-growing cancers not currently being treated — confirm with trial site)
• People who have had a major surgical procedure within 28 days before joining, or who are expected to need major surgery during the trial (other than for diagnostic purposes)
• People with a known serious allergy or sensitivity to nab-paclitaxel or any of its ingredients
• People with known psychiatric conditions or substance use disorders that would interfere with taking part in the trial
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 90 days after the last dose of trial treatment

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