NCT04914390: NeoATCT

A Phase Ⅱ Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer

Status unknown Phase 2 Last updated 22 January 2024

What this trial tests

Phase 2 trial testing AT regimen in Triple-negative Breast Cancer in 32 participants. Status unknown.

Timeline

15 September 2023

Primary endpoint
31 March 2025

30 September 2025

Quick facts

Lead sponsor	Sichuan Provincial People's Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	15 September 2023
Primary completion	31 March 2025
Estimated completion	30 September 2025
Sites	1 location across China

Drugs / interventions tested

• AT regimen — full drug profile →
• Tislelizumab (TISLELIZUMAB) — full drug profile →
• Anlotinib — full drug profile →

Conditions studied

• Triple-negative Breast Cancer — all drugs for Triple-negative Breast Cancer →

Sponsor

Sichuan Provincial People's Hospital

Who can join

Adults 18 to 75, female only, with Triple-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, single-arm and open-label phase II study, evaluating the efficacy and safety of anlotinib combined with tislelizumab and AT regimen as neoadjuvant treatment for triple-negative breast cancer. Participants will undergo/receive PDL1 testing after enrollment. All patients will be receive 6 cycles of low-dose anlotinib combined with tislelizumab and AT（Doxorubicin or Epirubicin+albumin-bound paclitaxel）regimen, followed by surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune evasion in cancer: mechanisms and cutting-edge therapeutic approaches.
   Tufail M, Jiang CH, Li N. · · 2025 · cited 82× · PMID 40739089 · DOI 10.1038/s41392-025-02280-1
2. Identification of Angiogenesis-Related Prognostic Biomarkers Associated With Immune Cell Infiltration in Breast Cancer.
   Tao D, Wang Y, Zhang X, Wang C, et al · · 2022 · cited 24× · PMID 35602610 · DOI 10.3389/fcell.2022.853324
3. The Combination of Immune Checkpoint Blockade with Tumor Vessel Normalization as a Promising Therapeutic Strategy for Breast Cancer: An Overview of Preclinical and Clinical Studies.
   Melaiu O, Vanni G, Portarena I, Pistolese CA, et al · · 2023 · cited 14× · PMID 36834641 · DOI 10.3390/ijms24043226
4. The Present and Future of Clinical Management in Metastatic Breast Cancer.
   Lin PH, Laliotis G. · · 2022 · cited 14× · PMID 36233758 · DOI 10.3390/jcm11195891
5. Evolving treatment landscape of immunotherapy in breast cancer: current issues and future perspectives.
   Valenza C, Rizzo G, Passalacqua MI, Boldrini L, et al · · 2023 · cited 10× · PMID 36743524 · DOI 10.1177/17588359221146129
6. Advances in the Management of Early-Stage Triple-Negative Breast Cancer.
   Bhardwaj PV, Wang Y, Brunk E, Spanheimer PM, et al · · 2023 · cited 7× · PMID 37569851 · DOI 10.3390/ijms241512478
7. 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
8. 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