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NCT05386524
Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC
Phase 2 trial testing sintilimab in Breast Cancer in 41 participants. Status unknown.
15 March 2025
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 15 June 2022 |
| Primary completion | 15 March 2025 |
| Estimated completion | 15 March 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- sintilimab — full drug profile →
- bevacizumab biosimilar — full drug profile →
- pegylated liposomal doxorubicin
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Divide and Conquer-Targeted Therapy for Triple-Negative Breast Cancer.
Nedeljković M, Vuletić A, Mirjačić Martinović K. · · 2025 · cited 10× · PMID 40003864 · DOI 10.3390/ijms26041396 -
Targeting Breast Cancer: The Familiar, the Emerging, and the Uncharted Territories.
Montazeri Aliabadi H, Manda A, Sidgal R, Chung C. · · 2023 · cited 6× · PMID 37759706 · DOI 10.3390/biom13091306 -
Triple-Negative Breast Cancer Systemic Treatment: Disruptive Early-Stage Developments for Overcoming Stagnation in the Advanced Pipeline.
Alonso-Ron C, Vethencourt A, González-Suárez E, Oruezabal RI. · · 2025 · cited 4× · PMID 40002228 · DOI 10.3390/cancers17040633 -
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 -
Narrative review on efficacy and safety of anti-angiogenesis in combination with immunotherapy in the treatment of breast cancer.
Deng X, Liu J. · · 2024 · cited 3× · PMID 39534580 · DOI 10.21037/tbcr-24-21
Verify or expand the search:
- PubMed search for NCT05386524
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
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- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet 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 NCT05386524 (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 Fudan University
- Last refreshed: 16 February 2023
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/NCT05386524.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing