Phase 2 Breast Cancer Trial, Recruiting
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 aged 18 or older (any gender)
- People who are fairly active and able to care for themselves, as measured by a standard medical fitness scale (ECOG score of 0 or 1)
- People who have been diagnosed with invasive breast cancer that is confirmed by tissue or cell testing, and falls into one of these categories: triple-negative breast cancer (where the cancer cells lack oestrogen receptors, progesterone receptors, and HER2); HER2-positive breast cancer; or hormone receptor-positive breast cancer that has continued to grow after at least two hormonal treatments, or that the treating doctor considers to be resistant to hormonal therapy (confirm with trial site, as this category requires advance approval from the study leadership)
- People who have confirmed spread of cancer to the lining of the brain and spinal cord (leptomeningeal metastasis), shown through spinal fluid testing and/or medical imaging, with or without known brain metastases
- People whose kidneys, blood counts, and liver are functioning at adequate levels as determined by blood tests (confirm specific values with trial site)
- People who are able to give informed consent
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 had an allergic reaction or serious side effect from methotrexate
- People with severe heart failure (New York Heart Association Class greater than 3)
- People with an active condition called diabetes insipidus (a condition affecting fluid balance in the body)
- People who currently have active mucositis (painful inflammation and sores in the mouth or digestive tract)
- People who have received chemotherapy or targeted radiotherapy to a small area of the brain within the past 2 weeks
- People who have received partial brain radiotherapy (covering less than 40% of the total brain) within the past 2 weeks
- People who have received whole brain radiotherapy within the past 6 months, or partial brain radiotherapy covering more than 40% of the brain within the past 6 months
- People who have received any treatment containing methotrexate given through the bloodstream (not via spinal injection) within the past year
- People who are currently receiving or planning to receive chemotherapy, radiotherapy, new hormonal therapy, or new anti-HER2 therapy for their breast cancer during the trial (note: continuing an existing anti-HER2 therapy may be permitted — confirm with trial site)
- People whose cancer or other health conditions are not well controlled, or where the treating doctor considers the study treatment to be unsuitable or unsafe
- People who are unable to have an MRI scan
- People who have used aspirin-type medications, anti-inflammatory drugs (such as ibuprofen), or sulfonamide antibiotics within one week before starting methotrexate
- People who are pregnant or breastfeeding
- People with significant fluid build-up in body cavities — such as large amounts of fluid in the abdomen, around the heart, or in the lungs — may be excluded, as this can affect how the body processes methotrexate; specific fluid thresholds apply and the study leadership must be consulted (confirm with trial site)
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.
Contact this trial
Principal Investigator: Roy Strowd, MD, Wake Forest University Health Sciences
Phone: 336-713-7748
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Overall Survival (at 12 weeks)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.