NCT06140576 is a Phase 1, PHASE2 clinical trial of Sindilimab in Breast Neoplasms, sponsored by Zhejiang Cancer Hospital.

Who is sponsoring NCT06140576?

NCT06140576 is sponsored by Zhejiang Cancer Hospital.

What drugs are being tested in NCT06140576?

Interventions in NCT06140576: Sindilimab, Nab-paclitaxel, Lenvatinib.

What condition does NCT06140576 study?

NCT06140576 studies Breast Neoplasms.

Is NCT06140576 still recruiting?

NCT06140576 is currently not yet recruiting. Last updated 20 November 2023.

Last reviewed 2023-11-20 · How we verify

NCT06140576

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.

Not yet recruiting Phase 1, PHASE2 Last updated 20 November 2023

What this trial tests

Phase 1, PHASE2 trial testing Sindilimab in Breast Neoplasms in 58 participants. Not yet recruiting.

Timeline

30 November 2023

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	Zhejiang Cancer Hospital
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	30 November 2023
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

Sindilimab — full drug profile →
Nab-paclitaxel (nab-paclitaxel) — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →

Conditions studied

Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Zhejiang Cancer Hospital

Who can join

Adults 18 to 70, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The treatment regimen of lenvatinib combined with PD1 antibody has brought earth shaking changes to the immunotherapy of various "cold tumors". This is a phase Ib/IIa clinical trial to investigate the efficacy and safety of Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for recurrent and metastatic triple negative breast cancer.

Publications & conference data

4 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
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
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
Cytokine Networks in Triple-Negative Breast Cancer: Mechanisms, Therapeutic Targets, and Emerging Strategies.
Rosado-Sanz M, Martínez-Alarcón N, Abellán-Soriano A, Golfe R, et al · · 2025 · cited 2× · PMID 40868199 · DOI 10.3390/biomedicines13081945

Verify or expand the search:

Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · recruiting

Other Zhejiang Cancer Hospital trials

Trials by the same sponsor.

NCT07343479 — Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases · Phase 2 · not yet recruiting
NCT07441720 — Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT) · Phase 2 · recruiting
NCT07416890 — Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Ref · Phase 2 · recruiting
NCT07326150 — Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Canc · active not recruiting
NCT07330544 — A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Rec · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06140576 (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 Zhejiang Cancer Hospital
Last refreshed: 20 November 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/NCT06140576.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing