Phase 2 Breast Cancer Trial, By Invitation
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
- People who are 18 years of age or older at the time of signing the consent form.
- People who are able to follow the study plan, as assessed by the trial doctor.
- People who have a tumour tissue sample available to confirm a HER2-positive diagnosis.
- People whose cancer has been tested and confirmed as HER2-positive — either scored 3+ on an IHC test, or scored 2+ on an IHC test with a positive FISH test result — based on previous tissue samples or a new biopsy taken before joining the study.
- People whose cancer can be measured by CT or MRI scan, with at least one detectable area of disease (confirm with trial site for full details).
- People with metastatic or recurrent breast cancer that cannot currently be fully removed by surgery.
- People with metastatic or recurrent breast cancer who have already received at least one round of treatment, which must have included trastuzumab and taxanes.
- People with a physical performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity.
- People with blood and organ function results that meet the required levels, tested within 14 days before starting the study treatment.
- Women who are able to become pregnant must either abstain from heterosexual intercourse or use an approved method of contraception.
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 an antibody-drug conjugate (ADC) medication or a CDK4/6 inhibitor as part of cancer treatment.
- People who have previously been treated with anti-HER2 medications other than trastuzumab, pertuzumab, or tyrosine kinase inhibitors (TKIs).
- People whose breast cancer has spread to the central nervous system (brain or spinal cord).
- People who have been diagnosed with another cancer in the 5 years before screening, with some exceptions such as certain early-stage or non-invasive cancers (confirm with trial site for full details).
- People who have serious problems with the functioning of a major organ before joining the study (confirm with trial site for full details).
- People who have taken part in another clinical trial and received an experimental drug within 28 days before starting this study.
- People who are known to have a sensitivity or allergic reaction to CDK4/6 inhibitors.
- People whose pregnancy blood test result is positive.
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
Primary endpoints
Objective Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.