Printed from Voxsanity (voxsanity.com.au) — NCT06393374 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Breast Cancer Trial, Recruiting
NCT06393374
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 confirmed (by a central laboratory) to have triple-negative breast cancer (TNBC), as defined by the latest standard medical guidelines
- People who show no signs of the cancer returning or spreading, as assessed by their treating doctor
- People who received a specific pre-surgery chemotherapy and immunotherapy treatment plan (pembrolizumab combined with carboplatin/taxanes, then pembrolizumab combined with anthracycline-based chemotherapy), followed by surgery in line with standard TNBC treatment guidelines
- People whose surgery successfully removed all visible cancer from the breast and/or lymph nodes, and who have sufficiently recovered from that surgery
- People whose surgical results showed that cancer cells were still present after pre-surgery treatment (meaning the cancer did not fully disappear, known as a non-pathologic complete response)
- People who are able to continue receiving pembrolizumab as post-surgery treatment
- People for whom the process of being entered into the trial can be completed within 16 weeks of their surgery
- People who have completed post-surgery radiation therapy (if it was required) and have recovered from it before entering the trial
- People who have provided a tissue sample from their surgery for laboratory testing of a protein called TROP2
- People who are capable of producing sperm and who agree not to donate sperm, and to either abstain from sex or use highly effective contraception for specified periods after the last dose of each study treatment (120 days for sacituzumab tirumotecan; 95 days for capecitabine; no restriction for pembrolizumab)
- People assigned female at birth who are not pregnant or breastfeeding, and who either are not of childbearing potential, or who are of childbearing potential and agree to use highly effective contraception for specified periods after the last dose of each study treatment (210 days for sacituzumab tirumotecan; 120 days for pembrolizumab; 185 days for capecitabine), and who agree to avoid breastfeeding during the study and for at least 120 days after the last dose
- People whose side effects from previous cancer treatments have mostly resolved to a mild level or returned to their normal baseline (hair loss is an exception)
- People living with HIV, provided their HIV is well controlled with antiviral medication
- People with a general health and activity level rated as 0 or 1 on a standard scale (meaning fully active or able to carry out light activity), assessed within 7 days before the first dose of study treatment
- People who test positive for hepatitis B surface antigen, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and have an undetectable hepatitis B viral level before entering the trial
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 known to carry a harmful BRCA gene mutation and for whom adjuvant treatment with olaparib is approved and available
- People who have moderate-to-severe nerve damage (peripheral neuropathy graded above 2)
- People with a history of severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that interferes with corneal healing
- People with active inflammatory bowel disease requiring immune-suppressing medication, or a past history of conditions such as Crohn's disease, ulcerative colitis, or chronic diarrhoea
- People with serious, uncontrolled heart or blood vessel conditions — including severe heart failure, unstable chest pain, recent heart attack, uncontrolled irregular heartbeat, a specific abnormal heart rhythm reading, or other serious heart or stroke-related conditions occurring within the 6 months before starting the study treatment
- People who have previously received a treatment that targets the TROP2 protein delivered via an antibody drug conjugate (ADC), or an ADC containing a topoisomerase I inhibitor
- People who have already received any post-surgery cancer treatment (other than radiation therapy), such as chemotherapy, targeted drugs, PARP inhibitors, ADCs, or immunotherapy
- People currently taking strong CYP3A4 enzyme-affecting medications (either boosters or blockers) that cannot be stopped for the duration of the study (a 2-week washout period before starting sacituzumab tirumotecan is required)
- People who have previously received certain types of immunotherapy drugs (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar immune checkpoint treatments), except for pembrolizumab used as pre-surgery treatment for early-stage TNBC
- People who have received prior systemic cancer treatment (including experimental treatments) within 4 weeks before entering the trial, except for chemotherapy used as pre-surgery treatment for early-stage TNBC
- People who received radiation therapy within 3 weeks before starting the study, or who still require steroid medication for radiation-related side effects that cannot be stopped before the first dose
- People who received a live or live-attenuated vaccine within 30 days before the first study dose (vaccines using inactivated agents are permitted)
- People who have taken part in another experimental treatment study or used an experimental medical device within 4 weeks before starting the study
- People with another cancer that is currently active or has required treatment within the past 5 years
- People with a known immune system deficiency, or who are taking steroid medication at a dose above 10 mg of prednisone (or equivalent) per day, or any other immune-suppressing treatment within 7 days before the first study dose
- People with an active autoimmune disease that has needed systemic treatment within the past 2 years (standard hormone or replacement therapies such as thyroid medication, insulin, or low-dose steroids are permitted)
- People with a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease) that previously required steroid treatment, or who currently have either condition
- People with an active infection currently requiring systemic treatment
- People living with HIV who also have a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- People with both hepatitis B and hepatitis C infections active at the same time
- People who have received a transplant of donor tissue or a solid organ
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: Medical Director, Merck Sharp & Dohme LLC
Phone: 1-888-577-8839
Australian sites
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703), Macquarie University, New South Wales
+61298122979
+61298122979
Westmead Hospital ( Site 2700), Westmead, New South Wales
+61288906728
+61288906728
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701), Brisbane, Queensland
+610736470209
+610736470209
Frankston Hospital-Oncology and Haematology ( Site 2704), Frankston, Victoria
+61397847777
+61397847777
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
24 June 2024
Est. completion
16 December 2030
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇨🇦 Canada
🇨🇴 Colombia
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇮 Finland
🇫🇷 France
🇩🇪 Germany
🇬🇷 Greece
Hong Kong
🇮🇪 Ireland
🇮🇱 Israel
🇮🇹 Italy
🇯🇵 Japan
🇲🇾 Malaysia
🇲🇽 Mexico
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇸🇬 Singapore
🇰🇷 South Korea
🇪🇸 Spain
🇸🇪 Sweden
🇨🇭 Switzerland
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
4 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?
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.