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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06849492
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 older than 18 years of age.
- People with a good general performance level, able to carry out normal daily activities with little or no restriction (ECOG performance score of 0 or 1).
- People with a life expectancy of at least 3 months.
- People who have been confirmed by tissue testing to have triple-negative breast cancer that has come back or spread to other parts of the body (a specific type that tests negative for HER2, estrogen receptors, and progesterone receptors, based on laboratory results).
- People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines (RECIST 1.1).
- People who have not yet received any systemic (whole-body) cancer treatments since their cancer returned or spread.
- People who are able to provide enough tissue samples for a specific type of analysis — at least 15 unstained tissue slides from a recent biopsy of a spread lesion, or from the original tumour if no prior treatment has been given.
- People with adequate bone marrow, liver, kidney, and other organ function as assessed by the trial site.
- People who are willing to participate, able to sign a consent form, willing to follow the study schedule, and willing to attend follow-up visits.
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 cancer that has spread to the lining around the brain or spinal cord, or who have cyst-like spread lesions, as confirmed by MRI or spinal fluid testing.
- People who have a build-up of fluid in body cavities (such as the abdomen, around the lungs, or around the heart) that is not being well controlled.
- People who have received any systemic cancer treatment within 14 days before enrolling in the trial.
- People whose scans show that the tumour has grown into major blood vessels, or where the treating doctor believes the tumour is very likely to do so during the study, creating a risk of serious bleeding.
- People with uncontrolled or symptomatic high calcium levels in the blood, or people who need ongoing bone-strengthening medication (bisphosphonates) to manage high calcium levels.
- People who have previously been treated with certain types of immune therapy other than PD-1/PD-L1 drugs (such as CTLA-4 antibodies), or with anti-blood-vessel-growth treatments (including certain antibody or targeted therapies).
- People who have had another cancer in the past 5 years and received treatment for it (surgery, radiotherapy, or systemic treatment), with certain exceptions such as fully cured in-situ cancers, cervical, basal cell, squamous cell, thyroid, or certain other cancers.
- People who have had major surgery unrelated to breast cancer within 4 weeks before enrolling, or who have not fully recovered from such surgery (note: diagnostic biopsies and central line insertions are generally allowed).
- People with a known or suspected autoimmune disease, except for those with autoimmune thyroid disease managed only with hormone replacement, or stable, well-controlled type 1 diabetes.
- People with interstitial lung disease, non-infectious lung inflammation, or other uncontrolled conditions affecting the whole body (such as uncontrolled diabetes or lung fibrosis).
- People who have received a live or weakened-live vaccine within 28 days before the first dose, or who plan to receive one during the study.
- People with HIV infection or AIDS; people with active hepatitis B or C, or both; or people with autoimmune hepatitis.
- People who have had a serious infection (such as a blood infection or severe pneumonia requiring hospitalisation) within 4 weeks before the first dose; people with an active infection needing antibiotic treatment within 2 weeks before the first dose; people with an unexplained fever above 38.5°C at the time of screening; or people with evidence of active tuberculosis within the past year.
- People who have had, or are planned to have, a bone marrow or solid organ transplant from another person.
- People with moderate or severe nerve damage affecting the hands or feet (peripheral neuropathy of grade 2 or higher).
- People with serious heart disease or significant heart-related conditions (confirm with trial site for specific details).
- People who have received treatments that stimulate the immune system (such as interferon or interleukin-2) within 4 weeks before the first dose.
- People who have received treatments that suppress the immune system (such as steroids at higher than low physiological doses, azathioprine, methotrexate, thalidomide, or anti-inflammatory biologics) within 2 weeks before the first dose (note: low-dose steroids, or inhaled or nasal sprays containing steroids, may still be acceptable).
- People with a known allergy to the study drug or its ingredients, or a history of severe allergic reactions to other antibody-based medicines.
- Women who are pregnant or breastfeeding, women of childbearing potential who test positive for pregnancy, or women who are unwilling to use effective contraception throughout the study.
- People with a documented history of neurological or psychiatric conditions such as epilepsy or dementia, or a known history of substance misuse, alcohol dependence, or drug addiction.
- People whom the treating doctor considers unsuitable for the trial 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.
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.
Contact this trial
Phone: +86 13661940232
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
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 April 2025
Est. completion
31 December 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.