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Triple Negative Breast Cancer (TNBC) / Ipilimumab 2.5 mg / BreakVax · Phase 1/2 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1/2 trial evaluating a personalized multicomponent immunotherapy strategy (BreakVax plus ipilimumab, pembrolizumab, chemotherapy, losartan, and aspirin) in PD-L1 negative, gBRCA negative, triple-negative breast cancer. No results are yet reported in this registry record; the study is designed to assess safety, feasibility, and preliminary antitumor activity in an estimated 10 participants.
Phase 1/2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Triple-Negative Breast Cancer (TNBC); age from 18 Years; to 72 Years. Intervention: BreakVax Arm. Compared with: Delayed BreakVax Arm — Active Comparator. n = 10. 1 site: United States.
This is a planned Phase 1/2 trial evaluating a personalized multicomponent immunotherapy strategy (BreakVax plus ipilimumab, pembrolizumab, chemotherapy, losartan, and aspirin) in PD-L1 negative, gBRCA negative, triple-negative breast cancer. No results are yet reported in this registry record; the study is designed to assess safety, feasibility, and preliminary antitumor activity in an estimated 10 participants.
Study includes both safety lead-in and randomized phases; allocation and blinding status not fully detailed.
This registry record documents a planned early-stage trial; no efficacy or safety data are available to inform clinical decision-making. The study design includes crossover to the investigational combination for patients who progress on standard chemotherapy, which may provide preliminary signals of activity in this treatment-resistant population if results are eventually reported.
This is a Phase 1/2 registry record for a planned study with no reported results; enrollment is estimated at only 10 participants across a safety lead-in and randomized cohort, making it an early-stage feasibility and safety assessment.
As stated by the source record.
Quoted from the source exactly as published.
This registry record documents a planned early-stage trial; no efficacy or safety data are available to inform clinical decision-making. The study design includes crossover to the investigational combination for patients who progress on standard chemotherapy, which may provide preliminary signals of activity in this treatment-resistant population if results are eventually reported.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07762703). This is a study registration, not published results. Lead sponsor: BreakBio Corp. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 10 participants (ESTIMATED). Conditions: Triple-Negative Breast Cancer (TNBC). Interventions: DRUG: BreakVax; DRUG: Ipilimumab 2.5 mg; DRUG: Pembrolizumab; DRUG: Standard-of-care chemotherapy; DRUG: Losartan and aspirin. Primary outcome measures: Immune-related Objective Response Rate (irORR) per iRECIST Assessed by Independent Review Committee , From start of assigned treatment through disease progression; for the Delayed BreakVax Arm, through progression on chemotherapy before crossover to BreakVax, up to 2 years; Disease Control Rate (DCR) Following Crossover to BreakVax Combination Treatment , From initiation of BreakVax combination treatment after crossover through subsequent disease progression, up to 2 years; Percentage of patients for whom BreakVax is successfully manufactured , up to 24 Months; Adverse events , up to 24 Months. Brief summary: The objective of this study is to evaluate the safety, feasibility, and preliminary antitumor activity of this multi-component immunotherapy strategy in patients with advanced solid tumors. The study is designed to assess whether coordinated enhancement of antigen-specific T-cell priming and tumor microenvironment modulation can improve immune-mediated tumor control. In this study, BreakVax with adjuvants (Montanide and Poly-ICLC) is administered in combination with: 1. Low-dose subcutaneous ipilimumab at the injection site as a dendritic cell adjuvant to enhance local dendritic cell-mediated T-cell priming; 2. Pembrolizumab to mitigate PD-1-mediated T-cell exhaustion and sustain effector function; 3. Standard-of-care chemotherapy, which may promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment; and 4. Losartan and aspirin, which have been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling. The study consists of two components: a Safety Lead-in Cohort and a randomized combination therapy cohort. The Safety Lead-in Cohort is designed to evaluate safety and tolerability of the study combination and to characterize dose-limiting toxicities (DLTs). The randomized combination therapy cohort portion is designed to evaluate the antitumor activity of the study combination compared with standard-of-care (SOC) chemotherapy of physician's choice, as measured by objective response rate (ORR), and to evaluate disease control rate (DCR) in patients who receive the study combination following progression on SOC chemotherapy.
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