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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06229067
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
- Women aged 18 or older who have signed a consent form and are expected to live for at least 3 more months.
- People whose general physical health and ability to carry out daily activities meets a certain level, as measured by a standard medical scoring system, within 21 days before the first dose (confirm with trial site).
- People with confirmed metastatic triple-negative breast cancer, documented according to established medical guidelines.
- People with metastatic breast cancer who have received no more than one prior course of chemotherapy for the metastatic disease.
- People who have at least one tumour that can be measured using standard imaging criteria.
- People who have previously been treated with chemotherapy drugs called anthracyclines and/or taxanes, either before their cancer came back, or whose cancer did not respond to those treatments.
- People who the treating doctor considers unsuitable for first-line treatment with anthracycline and/or taxane-based chemotherapy.
- People who have finished radiotherapy at least 4 weeks before the first dose of the study medication.
- People who have had surgery at least 30 days before the first dose and have fully recovered from it.
- People whose bone marrow is functioning normally, based on blood test results showing adequate levels of neutrophils, platelets, and haemoglobin.
- People whose liver is functioning normally, based on blood test results for bilirubin, liver enzymes, and alkaline phosphatase within acceptable ranges.
- People whose kidneys are functioning normally, based on a calculated kidney filtration rate above a set level.
- Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose and must agree to use contraception throughout the trial.
- People who are able to understand and voluntarily sign the consent form before any study procedures begin.
- People who are willing and able to attend all required study visits and follow the trial's 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 have had, or currently have, a cancer other than breast cancer, unless it was a skin cancer (non-melanoma), cervical carcinoma in situ, or another solid tumour that was fully treated with no signs of disease activity in the past 3 years.
- People whose only signs of disease are pleural effusion (fluid around the lungs), ascites (fluid in the abdomen), bone metastases, or other lesions that cannot be measured using standard imaging criteria.
- People with conditions that affect how the gut absorbs food or medication, including certain prior stomach or small intestine surgeries.
- People who have difficulty swallowing or are unable to swallow tablets.
- People with active or symptomatic spread of cancer to the brain or the lining of the brain and spinal cord.
- People found to have other serious medical conditions during the screening process, including significant heart disease, unstable diabetes, uncontrolled high calcium levels, or a significant active infection within the past 2 weeks.
- People who have had an organ transplant.
- People with nerve damage (peripheral neuropathy) rated at grade 2 or higher on a standard medical scale.
- People currently receiving any other cancer treatment for metastatic breast cancer.
- People who require blood-thinning (anticoagulant) medication at the same time as the study treatment.
- People who are pregnant, breastfeeding, or unwilling to use effective contraception for the entire study period and for at least one month after the last dose.
- People with a known history of neurological or psychiatric conditions that could affect their ability to follow the treatment plan.
- People whose last chemotherapy ended less than 3 weeks before the first dose of the study medication.
- People whose cancer got worse during or after treatment with an oral investigational drug.
- People who have taken part in another clinical trial or used an investigational drug or device within 30 days before starting this study.
- People with a known allergy to any ingredient in the study drug.
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.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
19 January 2024
Est. completion
19 January 2025
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Progression-free Survival
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.
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.