Printed from Voxsanity (voxsanity.com.au) — NCT05519670 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT05519670
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Adults (men or women) aged 18 or older.
- People who have been diagnosed with advanced breast cancer (either spread to other parts of the body, or locally advanced), confirmed by a tissue sample.
- People whose tumor does not have high levels of a protein called HER2, as confirmed by specific lab tests on the tumor tissue.
- People whose hormone receptor status (whether the cancer is driven by hormones) has been tested and is known.
- People whose cancer is not responding to hormone-based treatments — either because the cancer is hormone receptor-negative, or because it has stopped responding to a type of hormone therapy called an aromatase inhibitor (with specific prior treatment requirements that the trial site can clarify).
- People whose cancer has continued to grow and who are considered suitable for treatment with a medicine called capecitabine, after having previously received chemotherapy drugs known as taxanes and anthracyclines (unless those treatments were not suitable for them).
- People who have a tumor tissue sample available for testing — either a stored sample from within the last 6 months, or a new biopsy if no stored sample is available.
- People who have measurable disease, meaning at least one tumor that can be measured using standard imaging guidelines.
- People who have a history of brain or central nervous system (CNS) metastases that have already been treated, provided all of the following conditions are met:
- There is still measurable or detectable disease outside the brain or spinal cord.
- There is no history of bleeding inside the brain or spinal cord.
- The brain metastases are only in certain areas of the brain (the cerebellum or upper brain regions), and not in the brainstem or spinal cord.
- There is no sign that the cancer in the brain grew or changed between finishing brain-directed treatment and the scan done at screening.
- No stereotactic (targeted) radiation to the brain within 7 days before starting the study treatment, and no whole-brain radiation within 14 days before starting.
- No ongoing need for steroid medications to manage brain metastases (seizure medications at a stable dose are allowed).
- People with newly found brain metastases detected at screening, who receive radiation or surgery for them before joining, may still be eligible (confirm with trial site).
- People with an estimated life expectancy of at least 3 months.
- People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
- People whose blood counts and clotting function meet specific minimum levels, as tested by blood tests (confirm with trial site for exact values).
- People whose liver is functioning adequately, as shown by blood test results within acceptable ranges (including a specific exception for a condition called Gilbert's Syndrome).
- People whose kidneys are functioning adequately, as shown by blood test results within acceptable ranges.
- People whose levels of certain minerals in the blood (such as potassium, calcium, magnesium, sodium, and phosphorus) are within normal ranges.
- People who have normal blood pressure, or whose blood pressure is well managed with treatment.
- Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or agree to use a highly effective form of contraception during the trial and for at least 180 days after stopping the study treatment.
- Women who are able to become pregnant must have a negative pregnancy test within 72 hours before the first dose of study treatment.
- Men who agree to avoid donating sperm and to use a condom during the trial and for at least 90 days after the last dose of study treatment.
- People who are enrolled in a social security or health insurance system (as required in the country where the trial is running).
- People who have read the study information and signed a written consent form agreeing to participate.
- People who are able to swallow tablets or capsules.
- For a specific part of the trial called the expansion cohort: eligibility will also depend on the results of a test related to a DNA repair process in the tumor (confirm with trial site).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have previously been treated with both a PARP inhibitor and capecitabine for metastatic disease (people who received these in an earlier, non-metastatic setting may still be eligible if it has been at least 2 years since finishing that treatment and the cancer has since spread).
- People who have a deficiency in an enzyme called Dihydropyrimidine dehydrogenase (DPD), which affects how the body breaks down certain chemotherapy drugs.
- People who have received cancer chemotherapy or targeted therapy within 2 weeks before starting the study, hormone therapy within 7 days before starting, or an experimental treatment within 4 weeks (or within a time based on how long that drug stays in the body, whichever is longer).
- People who have not completed palliative radiation therapy at least 14 days before the first day of the study treatment (bone-protecting treatments such as bisphosphonates or denosumab are allowed).
- People who have had major surgery within 3 weeks before joining, or who have not yet fully recovered from earlier major surgery.
- People who still have significant side effects (rated grade 2 or higher on a standard medical scale) from previous cancer treatment, except for hair loss or a specific level of nerve-related side effects.
- People with weakened immune systems (for example, due to HIV) — though people with well-controlled HIV and undetectable virus levels may be eligible for part of the trial (confirm with trial site).
- People who have serious, uncontrolled medical conditions, including uncontrolled infections, heart failure, uncontrolled high blood pressure, unstable chest pain, irregular heartbeat, active stomach ulcers or gastritis, active bleeding disorders, or a rare brain condition called Posterior Reversible Encephalopathy Syndrome (PRES).
- People with a heart rhythm measurement (called QTc interval) of 470 milliseconds or more, based on an average of three consecutive heart tracing tests.
- People with active or previously diagnosed inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
- People who are unable to swallow medications, who have digestive conditions that may prevent proper absorption of one of the study drugs (niraparib), or who are on long-term oral blood-thinning medication.
- Women who are pregnant or breastfeeding, or who plan to breastfeed during the study or within 30 days after the last dose of study treatment.
- People with a known allergy or sensitivity to niraparib, capecitabine, or any of the ingredients in these medicines.
- People who are currently taking, or have taken within the past 4 weeks, antiviral medicines called sorivudine or brivudine.
- People who have received a blood transfusion (red blood cells or platelets) within 4 weeks before starting the study.
- People who have received blood cell-stimulating injections (such as G-CSF or erythropoietin) within 4 weeks before starting the study.
- People who experienced severe and prolonged low blood counts (grade 3 or 4 anaemia, low white blood cells, or low platelets lasting more than 4 weeks) caused by previous chemotherapy.
- People who have a history of certain blood-related conditions called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
- People who have been diagnosed with or treated for another type of cancer within the past 2 years — with exceptions for certain skin cancers, cervical cancer in situ that has been fully treated, and a non-invasive breast condition called ductal carcinoma in situ (DCIS).
- People with known active hepatitis B or hepatitis C infection.
- People who have received a live vaccine within 30 days before the planned start of the study.
- People who currently have, or have recently had, inflammation of the lungs (pneumonitis) requiring steroid or immune-modifying treatment within 90 days before the planned start of the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Institut Paoli-Calmettes
Registry
ClinicalTrials.gov
Start date
1 March 2023
Est. completion
1 September 2027
Primary endpoints
Dose-Limiting Toxicities (DLT); efficacy with objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 1 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.