Printed from Voxsanity (voxsanity.com.au) — NCT05770531 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Breast Cancer
Phase 2 Breast Cancer Trial, Recruiting
NCT05770531
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 stage IV (metastatic) triple-negative breast cancer (ER-negative, PR-negative, and HER2-negative), confirmed by a tissue biopsy.
- People whose cancer tests show HER2-negative results, defined by specific laboratory testing methods (confirm with trial site for exact test result requirements).
- People whose cancer tests show that fewer than 10% of cancer cells are responding to hormone receptors (ER and PR).
- People whose cancer tests show a low PD-L1 score (called a combined positive score below 10), or who are otherwise not suitable for a type of treatment called checkpoint inhibitors.
- People who have at least one area of cancer that can be measured on a scan, with that scan completed within 28 days before starting the study treatment.
- People aged 18 or older — both male and female.
- People who are considered well enough to carry out basic daily activities, based on a standard medical scale (ECOG performance score of 0, 1, or 2).
- People who are willing and able to read and sign a consent form before joining the study.
- People who have not previously received chemotherapy for their metastatic disease.
- People with adequate blood counts (sufficient white blood cells and platelets), confirmed by a blood test taken within 28 days before starting the study drug.
- People with liver function test results within acceptable ranges (specific thresholds depend on whether liver spread is present — confirm with trial site), tested within 28 days before starting the study drug.
- People with a specific liver condition called Gilbert's disease must have a bilirubin level below a certain threshold (confirm with trial site).
- People who are not post-menopausal or surgically sterile must agree to use two reliable non-hormonal methods of contraception during treatment and for at least 30 days after the last dose. Hormone-based contraceptives (such as the pill) are not permitted during the study.
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 whose cancer has spread to the membranes surrounding the brain or spinal cord (called leptomeningeal disease).
- People with cancer-related pain that is not well controlled, unless they are on a stable pain medication regimen at the time of registration. Painful areas suitable for radiation treatment should ideally be treated before joining the study.
- People with high calcium levels in the blood that are uncontrolled or causing symptoms requiring ongoing bisphosphonate medication.
- People who have had another cancer (other than triple-negative breast cancer) within the past 5 years, with exceptions for certain low-risk, successfully treated cancers such as early-stage skin cancer or cervical carcinoma in situ (confirm with trial site).
- People who are currently receiving other cancer treatments such as chemotherapy, radiation, surgery, immunotherapy, or biological therapy outside of what the study specifies.
- Women who are pregnant or breastfeeding.
- People with significant uncontrolled medical conditions that, in the treating doctor's opinion, could affect their ability to participate in the study — for example, severe liver disease, uncontrolled seizures, or a condition affecting blood flow through major veins.
- People with significant heart problems, such as moderate-to-severe heart failure, a heart attack within the past 3 months, unstable heart rhythm, or unstable chest pain. People with a known significantly reduced heart pumping function (ejection fraction below 35%) will also be excluded.
- People who have had a major surgical procedure within 4 weeks before joining the study, or who expect to need major surgery during the study. Placement of a port or central line for treatment is not considered a major procedure and is generally permitted.
- People with psychiatric illness or personal circumstances that could affect their safety or their ability to follow the study requirements.
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
Principal Investigator: Vandana Abramson, MD, Vanderbilt University/Ingram Cancer Center
Phone: 800-811-8480
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
Recruiting
Phase
Phase 2
Sponsor
Vanderbilt-Ingram Cancer Center
Registry
ClinicalTrials.gov
Start date
3 October 2023
Est. completion
1 August 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Progression-free survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.