OncoMatch/Clinical Trials/NCT07394387
Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.
Is NCT07394387 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Abraxane for triple negative breast cancer (tnbc).
Treatment: Sintilimab · Abraxane · Carboplatin — Background: Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and/or PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment effectiveness. This study aims to investigate this new approach. Objective: To evaluate the effectiveness and safety of using HIFU, with or without a PD-1 inhibitor (Sintilimab), before and during combination chemotherapy in patients with early-stage TNBC. The primary goal is to determine if this strategy can increase the rate of pathological complete response (pCR). Study Design: This is a single-center, Phase II clinical study. Approximately 40 participants with Stage II-III TNBC will be enrolled and assigned to one of two groups (cohorts) without randomization: Cohort A: Receives HIFU treatment. Two weeks later, begins standard chemotherapy (Abraxane and carboplatin) combined with the PD-1 inhibitor Sintilimab for 6 cycles. Cohort B: Receives HIFU treatment combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, begins the same 6 cycles of chemotherapy (Abraxane and carboplatin) combined with Sintilimab. Main Measures: The primary measure is the rate of pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes after surgery following the completion of neoadjuvant therapy. Other important measures include: The ability of the treatment to activate the immune system (measured by changes in CD8+ T cells or IFN-γ). The percentage of patients whose tumors shrink significantly (Objective Response Rate). How long patients live without their cancer getting worse (Event-Free Survival). The rate of patients who can undergo breast-conserving surgery. The frequency and severity of side effects.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Required: Stage II, III
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status of 0 or 1
Demographics
Prior therapy
Cannot have received: radiotherapy for breast cancer
No prior radiotherapy for breast cancer
Cannot have received: chemotherapy for breast cancer
No prior chemotherapy for breast cancer
Cannot have received: immunotherapy for breast cancer
No prior immunotherapy for breast cancer
Cannot have received: endocrine therapy for breast cancer
No prior endocrine therapy for breast cancer
Cannot have received: targeted therapy for breast cancer
No prior targeted therapy for breast cancer
Cannot have received: major surgery for breast cancer
No prior major surgery for breast cancer
Lab requirements
Blood counts
Hemoglobin 90 g/L; white blood cell count 3.5D7 10^9/L; platelet count 100D7 10^9/L; absolute neutrophil count 1.5D7 10^9/L
Kidney function
Serum creatinine 1.5D7 ULN
Liver function
AST and ALT 3D7 upper limit of normal (ULN); total bilirubin 1.5D7 ULN
Cardiac function
No myocardial ischemia on ECG; NYHA class I; LVEF 55% on echocardiogram; normal cardiac markers (cTnI and BNP)
Adequate organ function, defined as: Hemoglobin 90 g/L; white blood cell count 3.5D7 10^9/L; platelet count 100D7 10^9/L; absolute neutrophil count 1.5D7 10^9/L; AST and ALT 3D7 upper limit of normal (ULN); total bilirubin 1.5D7 ULN; serum creatinine 1.5D7 ULN; no evidence of pneumonia on chest CT. Adequate cardiac function, defined as: No myocardial ischemia on ECG; NYHA class I; LVEF 55% on echocardiogram; normal cardiac markers (cTnI and BNP)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07394387 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage II or III is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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