Phase 1 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
- You are a male or female aged 18 or older
- You are willing and able to follow all study requirements throughout the trial
- Your breast cancer has been confirmed by a lab test (biopsy or cell sample) and is advanced or has spread to other parts of the body
- Your breast cancer is ER-positive (hormone receptor-positive) and HER2-negative, based on your most recent tumor sample
- Your cancer can be tracked and evaluated through scans or imaging, either through measurable tumors or through bone disease visible on scans
- Your doctor estimates you have a life expectancy of at least 6 months
- You are in generally good physical health and able to carry out daily activities with little to no limitation (performance status 0 or 1)
- You have received a limited number of prior hormonal treatments for your advanced or metastatic breast cancer (the exact number allowed depends on which treatment group you are assigned to — confirm with trial site)
- You have received no more than 1 prior chemotherapy treatment (including certain antibody-drug treatments) for locally advanced or metastatic breast cancer
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.
- You have or have had another cancer that could interfere with the safety or results of this trial
- You have significant, uncontrolled heart disease or abnormal heart rhythm problems
- You have had a stroke or other brain blood vessel problem within the last 6 months
- You have had a blood clot in your lungs or legs within the last 6 months, or your doctor considers you at high risk of developing a blood clot
- You have a history of lung inflammation (pneumonitis) or scarring lung disease (interstitial lung disease)
- Cancer has spread to the fluid around your brain and spinal cord, or is pressing on your spinal cord
- You have a digestive condition that could affect how your body absorbs tablets or capsules taken by mouth
- You have a known HIV infection
- You have significant liver disease, active hepatitis B or C, current alcohol abuse, or cirrhosis (confirm with trial site for exact liver function requirements)
- You have a history of a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (confirm with trial site)
- You currently have an active infection or are considered at high risk of developing a serious infection (for example, due to a weakened immune system, uncontrolled diabetes, or poor general health)
- You have significant other health conditions, such as a psychiatric illness, that could affect your ability to participate or affect the study results
- You have previously been treated with the study drug OP-1250
- You have previously been treated with a PI3K inhibitor drug (for Treatment Group 2) or an mTOR inhibitor drug (for Treatment Group 3) — confirm with trial site which group applies to you
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Dose Limiting Toxicities (DLTs); Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of palazestrant when administered with ribociclib, alpelisib, everolimus, or atirmociclib.; Pharmacokinetics (PK) of palazestrant when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4) .
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.