Last reviewed · How we verify
NCT05491694: HIFU
To Evaluate the Efficacy of Toripalimab Combined With Chemotherapy After HIFU Induction in the Treatment of Early Triple-negative Breast Cancer
Phase 2 trial testing Toripalimab in Breast Cancer in 20 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 September 2022 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2024 |
Drugs / interventions tested
- Toripalimab (TORIPALIMAB) — full drug profile →
- Epirubicin (EPIRUBICIN) — full drug profile →
- High Intensity Focused Ultrasoun
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- TNBC - Triple-Negative Breast Cancer — all drugs for TNBC - Triple-Negative Breast Cancer →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
18 and older, female only, with Breast Cancer or TNBC - Triple-Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunotherapy and its racial specificity for breast cancer treatment in Asia: a narrative review.
Xu RC, Zhang YW, Liu CC, Xu YY, et al · · 2025 · cited 3× · PMID 40443538 · DOI 10.1016/j.lanwpc.2024.101180 -
Therapeutic Ultrasound for Multimodal Cancer Treatment: A Spotlight on Breast Cancer.
Demir ZEF, Sheybani ND. · · 2025 · cited 3× · PMID 39971377 · DOI 10.1146/annurev-bioeng-103023-111151 -
Revisiting the standard of care for immune checkpoint inhibitors in early-stage triple-negative breast cancer: timing, duration, dose, combination, and patient selection.
Guo X, Li P, Wu W, Wang Y, et al · · 2026 · PMID 42079589 · DOI 10.3389/fimmu.2026.1795426
Verify or expand the search:
- PubMed search for NCT05491694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
- NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
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- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other The First Affiliated Hospital with Nanjing Medical University trials
Trials by the same sponsor.
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
- NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
- NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05491694 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 8 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05491694.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing