Phase 3 Breast Cancer Trial, RecruitingNCT05633654Sponsor: Gilead SciencesCondition: Breast Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT05633654 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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 might be able to join this trial:
Adults over 18 years old who have triple-negative breast cancer (a specific type of breast cancer that tests negative for three particular markers) and still had cancer remaining in the breast or lymph nodes after completing pre-surgery treatment (chemotherapy given before surgery)
People whose surgeon was able to remove all visible cancer from the breast and/or lymph nodes, and who have sufficiently recovered from that surgery
People who are able to provide tissue samples from both their original biopsy (before pre-surgery treatment) and from the cancer tissue removed during surgery
People who are in generally good physical health and able to carry out daily activities, as measured by a standard medical scoring system (ECOG score of 0 or 1 — confirm with trial site)
People who have already completed any required radiotherapy and have recovered from it before starting the trial treatment
People whose major organs (such as liver, kidneys, and blood cells) are functioning at an adequate level
Who may not be able to join:
People whose breast cancer has spread to other parts of the body (Stage IV/metastatic), or who have a history of invasive breast cancer in either breast
People who have previously received certain types of immune-based therapies (including treatments targeting CTLA-4, OX-40, or CD137), any HER2-targeted treatment, or hormone (endocrine) therapy lasting more than 4 weeks — or who plan to receive hormone therapy at the same time as the trial treatment
People who have signs that their cancer has come back after pre-surgery treatment and surgery
People who have previously received a specific class of chemotherapy drugs called topoisomerase 1 inhibitors, or certain targeted drug-delivery treatments (antibody-drug conjugates) that contain this type of drug
People who carry an inherited gene change (mutation) in the BRCA gene
People who have had a heart attack or severe chest pain (unstable angina) within the past 6 months, have a history of serious irregular heart rhythms, significant heart conduction problems, or have a weakened heart pumping function (below 50% — confirm with trial site)
People who currently have a serious active infection that requires antimicrobial treatment
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.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Gilead Study Director, Gilead Sciences
Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown, New South Wales
Kinghorn Cancer Centre, Darlinghurst, New South Wales
Lake Macquarie Private Hospital, Gateshead, New South Wales
Port Macquarie Base Hospital, Port Macquarie, New South Wales
Cairns Hospital, Cairns, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland
Cancer Research SA, Adelaide, South Australia
Bendigo Health, Bendigo, Victoria
Monash Medical Centre, Clayton, Victoria
Fiona Stanley Hospital, Murdoch, Western Australia
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.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT05633654
Sponsor: Gilead Sciences
Phase: Phase 3
Status: Recruiting
Condition: Breast Cancer
Trial contact: 1-833-445-3230 (GILEAD-0)
More information: https://clinicaltrials.gov/study/NCT05633654
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
Adults over 18 years old who have triple-negative breast cancer (a specific type of breast cancer that tests negative for three particular markers) and still had cancer remaining in the breast or lymph nodes after completing pre-surgery treatment (chemotherapy given before surgery)
People whose surgeon was able to remove all visible cancer from the breast and/or lymph nodes, and who have sufficiently recovered from that surgery
People who are able to provide tissue samples from both their original biopsy (before pre-surgery treatment) and from the cancer tissue removed during surgery
People who are in generally good physical health and able to carry out daily activities, as measured by a standard medical scoring system (ECOG score of 0 or 1 — confirm with trial site)
People who have already completed any required radiotherapy and have recovered from it before starting the trial treatment
People whose major organs (such as liver, kidneys, and blood cells) are functioning at an adequate level
Who may not be able to join:
People whose breast cancer has spread to other parts of the body (Stage IV/metastatic), or who have a history of invasive breast cancer in either breast
People who have previously received certain types of immune-based therapies (including treatments targeting CTLA-4, OX-40, or CD137), any HER2-targeted treatment, or hormone (endocrine) therapy lasting more than 4 weeks — or who plan to receive hormone therapy at the same time as the trial treatment
People who have signs that their cancer has come back after pre-surgery treatment and surgery
People who have previously received a specific class of chemotherapy drugs called topoisomerase 1 inhibitors, or certain targeted drug-delivery treatments (antibody-drug conjugates) that contain this type of drug
People who carry an inherited gene change (mutation) in the BRCA gene
People who have had a heart attack or severe chest pain (unstable angina) within the past 6 months, have a history of serious irregular heart rhythms, significant heart conduction problems, or have a weakened heart pumping function (below 50% — confirm with trial site)
People who currently have a serious active infection that requires antimicrobial treatment
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇺 Australia
🇧🇪 Belgium
🇧🇷 Brazil
🇫🇷 France
🇩🇪 Germany
🇮🇪 Ireland
🇮🇹 Italy
🇰🇷 South Korea
🇪🇸 Spain
🇬🇧 United Kingdom
🇺🇸 United States
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Invasive Disease-free Survival (iDFS)
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 27 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.