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
- People who have been diagnosed with breast cancer (confirmed by a tissue or cell sample) that has come back or spread to other parts of the body, and where surgery or radiation treatment is not recommended.
- People whose breast cancer has been tested and confirmed to be hormone receptor-positive (HR+) and HER2-negative or HER2-low, based on the most recent tumour sample (not including bone lesions), according to specific Chinese oncology guidelines (CSCO 2024).
- People who meet at least one of the following conditions related to menopause: have had both ovaries surgically removed; are aged 60 or older; are under 60 and have had no periods for 12 months or more without medication or illness causing it, with hormone levels in the postmenopausal range; or are under 60 and are currently receiving ovarian suppression treatment (such as LHRH agonist injections), with hormone levels in the postmenopausal range.
- People whose cancer has stopped responding to 1 or 2 previous hormone-based treatments for their recurrent or metastatic disease (such as aromatase inhibitors, SERDs, or SERMs) — noting that people whose tumour showed only very weak hormone receptor activity (1–10% of cells staining positive) are not eligible under this criterion.
- People whose cancer progressed during or after treatment with at least one CDK4/6 inhibitor drug, whether that was given before surgery, after surgery, or as a general systemic treatment.
- People who have had 0 to 2 previous rounds of chemotherapy (cytotoxic drug treatment) for their recurrent or metastatic disease — noting that antibody-drug conjugates (ADCs) do not count as chemotherapy for this purpose.
- People with a good general health and activity level, rated 0 or 1 on the ECOG performance scale (meaning fully active or able to carry out light activity).
- People who have at least one measurable area of disease visible on scans, as defined by standard measurement criteria (RECIST v1.1) — or, if bone lesions are the only areas of disease, those lesions must be of a specific type (lytic or mixed, not purely blastic/hardening).
- People whose blood tests show that their organs (such as liver, kidneys, and bone marrow) are functioning adequately.
- People who are receiving ovarian suppression therapy and agree to use effective contraception during the trial and for at least 3 months after treatment ends.
- People who are willing and able to give informed consent and follow the study requirements.
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 are currently pregnant or breastfeeding.
- People the trial doctor considers unsuitable for the study drug, including those with a serious allergy to the drug's ingredients, those who have previously received this study drug, or those with a potentially life-threatening condition such as uncontrolled fluid build-up around the lungs, heart, or abdomen.
- People with uncontrolled high blood pressure (above 150/100 mmHg, even after repeat measurements).
- People whose cancer has spread to the brain or central nervous system and has shown signs of getting worse in the 28 days before starting the trial (such as new or growing lesions on scans, or new neurological symptoms).
- People who currently have another active or progressing cancer (excluding certain low-risk skin cancers or previously cured cancers) — note that hormone replacement therapy (such as thyroid replacement after thyroid removal) is permitted.
- People who have taken corticosteroid medications at higher doses (more than 10 mg/day of prednisone or equivalent) or other immune-suppressing medications within the 14 days before starting the study drug.
- People who have received other anti-cancer treatments or experimental drugs too recently before starting the study drug (a washout period of approximately 5 half-lives or 14 days, whichever is shorter, is required).
- People who have had extensive radiation therapy or major surgery within the past 4 weeks, or localised palliative radiation within the past 2 weeks (confirm with trial site, as exceptions may be possible with sponsor agreement).
- People who have not yet recovered from significant side effects of previous cancer treatments (minor, low-grade side effects may be acceptable — confirm with trial site).
- People with a history of serious heart or stroke-related conditions.
- People with serious stomach or bowel conditions that could affect how the study drug is absorbed or processed by the body (such as complete stomach removal or short bowel syndrome) — the trial doctor will assess eligibility on a case-by-case basis.
- People who have bleeding disorders, clotting disorders, or who require anticoagulant therapy that needs INR monitoring.
- People who have recently taken certain medications that strongly affect how a specific liver enzyme (CYP3A) works, within 2 weeks or 5 half-lives before starting the study drug (whichever is shorter).
- People who have tested positive for HIV.
- People with active hepatitis B (HBV) or hepatitis C (HCV) infection.
- People who are unable to swallow or tolerate oral (tablet/capsule) medication.
- People whom the trial doctor considers unsuitable for any other reason.
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.
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.
Contact this trial
Phone: 025-58216298
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
Part A: safety evaluation parameters; Part B: Objective Response Rate (ORR) (RECIST v1.1)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.