A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Mod… (NCT07721259) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden
United States60 participantsStarted 2026-09-30
Plain-language summary
This phase II trial evaluates whether a multi-antigen vaccine called STEMVAC improves disease-free survival after surgery in patients with triple-negative breast cancer (TNBC) and moderate or extensive residual cancer burden. TNBC has an aggressive clinical course and poorer disease-free survival compared to other subtypes. While patients who have no remaining tumor in the breast or lymph nodes after surgery have excellent long-term outcomes, patients with moderate or extensive residual cancer burden remain at high risk for early disease return and poorer prognosis. STEMVAC is designed to target proteins that tumor cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Giving STEMVAC after surgery may improve disease-free survival rates in TNBC patients with moderate or extensive residual cancer burden.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2
* Triple-negative breast cancer as determined by the treating oncologist
* Completed standard of care neoadjuvant chemotherapy in the opinion of their treating oncologist
* Patients whose tumors progress on neoadjuvant therapy may be enrolled
* No clinical evidence of local or distant recurrence
* Plan to receive standard of care adjuvant directed therapy
* Completed standard of care locoregional treatment, including definitive breast and lymph node surgery followed by standard radiation therapy, if recommended
* Residual cancer burden (RCB) index 2 or 3 as calculated per routine anatomic pathology clinical standards
* Absolute neutrophil count (ANC) ≥ 800/μL (within 30 days of first study vaccine administration)
* Hemoglobin (Hgb) ≥ 8 g/dL (within 30 days of first study vaccine administration)
* Platelets ≥ 75,000/ μL (within 30 days of first study vaccine administration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome, in whom total bilirubin must be \< 3.0 mg/dL (within 30 days of first study vaccine administration)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (within 30 days of first study vaccine administration)
* Creatinine ≤ 1.5 x ULN mg/dL or creatinine clearance \> 60 mL/min (within 30 days of first study vaccine administration)
* At least…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Invasive breast cancer free survival (IBCFS)
Timeframe: Time from randomization to local or distant recurrence or death, assessed up to 3 years
2
Dynamics and characteristics of circulating tumor deoxyribonucleic acid (ctDNA)