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 are willing and able to give written consent to participate.
• People who are able to follow the study procedures and requirements.
• Women aged 18 or older.
• People whose breast cancer is "triple-negative," meaning lab tests show the tumour does not respond to oestrogen, progesterone, or a protein called HER2 (based on specific test score thresholds).
• People whose tumour tests negative for a protein called PDL1, based on a specific lab score below 10.
• People who have at least one tumour that has not been treated with radiation and can be measured on a scan (CT or MRI done within 28 days before joining the trial), or who have certain types of bone lesions (lytic or mixed lytic/sclerotic) — people with only sclerotic/osteoblastic bone lesions and no other measurable disease are not eligible (confirm with trial site).
• People who have tumour tissue samples available from a previous biopsy or surgery, or who have a tumour that can be biopsied.
• People whose general health and ability to perform daily activities is rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People with a life expectancy of at least 12 weeks.
• People whose blood counts and organ function (including liver, kidney, and blood clotting) meet specific minimum levels measured within 28 days before starting treatment (confirm exact values with trial site).
• People of childbearing potential who have a negative pregnancy test within 72 hours before starting treatment, and who agree to use highly effective contraception from 14 days before the first dose until 7 months after the last dose, and who agree not to donate or retrieve eggs during the study or for 7 months after the last dose.
• People who weigh more than 30 kg.

Who may not be able to join:

• People who have previously received chemotherapy, immunotherapy (including a drug called durvalumab), or PARP inhibitor drugs for advanced or metastatic breast cancer.
• People who have previously received certain immune checkpoint inhibitor drugs (such as atezolizumab or pembrolizumab), or certain targeted antibody-drug treatments (targeting TROP2 or HER2), in the earlier treatment setting within 6 months before joining this trial.
• People who have previously had a stem cell transplant from a donor or a solid organ transplant.
• People who have an immune system condition, or who are currently taking high-dose steroid tablets or injections (above a certain daily threshold), or who have taken oral or intravenous steroids in the 14 days before starting the trial (some forms of steroids such as inhaled, nasal, or topical steroids may be allowed — confirm with trial site).
• People who have received a live vaccine within 30 days before starting the trial (examples include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid vaccines; some flu vaccines that are injected are generally allowed, but the nasal spray flu vaccine is not).
• People with active or previously diagnosed autoimmune or inflammatory conditions such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions — though some exceptions may apply, such as for people with vitiligo, stable thyroid conditions on replacement therapy, skin conditions not requiring systemic treatment, conditions not active in the last 5 years, or coeliac disease controlled by diet alone (confirm with trial site).
• People with a history of certain lung conditions, including pulmonary fibrosis, drug-related or radiation-related lung inflammation, or active lung inflammation seen on a scan.
• People with an active infection requiring treatment with systemic medications.
• People with a history of HIV infection.
• People with an active hepatitis B or hepatitis C infection (some people with past or resolved hepatitis B or C may still be eligible — confirm with trial site).
• People with a known history of active tuberculosis.
• People with any other serious illness or condition that, in the doctor's judgement, would make participation unsafe or interfere with the study results.
• People whose personal, family, social, or geographic circumstances would make it difficult to follow the study protocol.
• People currently participating in another clinical trial or receiving another experimental drug within 28 days before joining this trial.
• People who are pregnant or breastfeeding.
• People who have had major surgery within 4 weeks before joining the trial, or who are expected to need major surgery during the study (other than for diagnosis).
• People who have had another cancer in the past 5 years, with the exception of certain low-risk cancers that have been treated with curative intent (such as some skin cancers or early-stage cervical conditions — confirm with trial site).
• People who have had a severe infection requiring hospitalisation within 28 days before joining the trial.
• People who still have significant side effects (graded 2 or higher on a standard scale) from previous cancer treatments, with some exceptions such as hair loss or certain stable lab values (confirm with trial site).
• People with poorly controlled ongoing illnesses such as active infection, heart failure, uncontrolled high blood pressure, unstable chest pain, irregular heartbeat, lung disease, or serious bowel conditions.
• People with a history of cancer spread to the membranes surrounding the brain or spinal cord.
• People with significant corneal eye disease.
• People with a history of severe allergic reactions to other monoclonal antibody treatments.
• People with a history of a primary immune deficiency condition.
• People with a known allergy or sensitivity to any of the drugs used in this trial or their ingredients.
• People with active brain metastases or cancer pressing on the spinal cord — people whose brain metastases have been treated and shown to be stable on scans for at least 4 weeks, with no ongoing neurological symptoms requiring high-dose steroids, may potentially be eligible (confirm with trial site).
• People with a specific heart rhythm measurement (QTcF) of 470 milliseconds or more, measured across three ECGs.
• People who have previously received certain immunotherapy drugs (anti-PD-1, anti-PD-L1, or anti-CTLA-4) and who experienced serious immune-related side effects, had to permanently stop those treatments due to side effects, required additional immune-suppressing medications, or still have unresolved side effects from those treatments (some exceptions may apply for mild hormonal side effects — confirm with trial site).

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