Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjentki w wieku 18-70 lat
- •Potwierdzony histologicznie zaawansowany nowotwór piersi, stadium II-III, typ trójujemny (TNBC)
- •Co najmniej jeden zmierzalny guz
- •Brak wcześniejszej chemioterapii, immunoterapii lub radioterapii z powodu raka piersi
- •Dobra sprawność fizyczna (ECOG 0-1)
- •Prawidłowe funkcje wątroby, nerek i składniki krwi
- •Prawidłowe funkcje serca (bez zawału, ejection fraction ≥55%)
- •Prawidłowa funkcja tarczycy i pisemna zgoda na udział
✗ Disqualifies
- •Mężczyźni lub rak zapalny piersi
- •Zaawansowany rak piersi z przerzutami (stadium IV)
- •Aktywne choroby autoimmunologiczne wymagające leczenia w ostatnich 2 latach
- •Inne nowotwory lub historia innych nowotworów w ostatnich 5 latach
- •Poważne choroby niezwiązane z nowotworem mogące wpłynąć na uczestnictwo
- •Duża operacja w ciągu 4 tygodni przed badaniem lub planowana podczas badania
- •Wcześniejsza radioterapia, chemioterapia lub operacja z powodu raka piersi
- •Uczulenie na składniki leku badanego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- May 15, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Trial contact
Wenbin Zhou, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.