NCT04877821: NeoSACT

The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC

Completed Phase 2 Last updated 2 April 2026

What this trial tests

Phase 2 trial testing Sintilimab in Triple Negative Breast Cancer in 29 participants. Completed in 10 March 2026.

Timeline

15 September 2021

Primary endpoint
31 August 2023

10 March 2026

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	15 September 2021
Primary completion	31 August 2023
Estimated completion	10 March 2026
Sites	1 location across China

Drugs / interventions tested

• Sintilimab — full drug profile →
• Anlotinib
• Nab paclitaxel
• Carboplatin (Carboplatin) — full drug profile →
• Epirubicin (EPIRUBICIN) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

Guangdong Provincial People's Hospital

Who can join

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

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of Sintilimab plus anlotinib combined with chemotherapy as neoadjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Sintilimab + anlotinib + chemotherapy) based on schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 4-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary outcome measure is pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0.

Publications & conference data

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

1. Recent advances in therapeutic strategies for triple-negative breast cancer.
   Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
2. Normalization of the tumor microenvironment by harnessing vascular and immune modulation to achieve enhanced cancer therapy.
   Choi Y, Jung K. · · 2023 · cited 100× · PMID 37907742 · DOI 10.1038/s12276-023-01114-w
3. Endothelial cells in tumor microenvironment: insights and perspectives.
   Leone P, Malerba E, Susca N, Favoino E, et al · · 2024 · cited 90× · PMID 38426109 · DOI 10.3389/fimmu.2024.1367875
4. 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
5. Research progress on immunotherapy in triple‑negative breast cancer (Review).
   Zhang X, Ge X, Jiang T, Yang R, et al · · 2022 · cited 20× · PMID 35762339 · DOI 10.3892/ijo.2022.5385
6. Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
   Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234
7. Improving efficacy of TNBC immunotherapy: based on analysis and subtyping of immune microenvironment.
   Yang Y, Li H, Yang W, Shi Y. · · 2024 · cited 11× · PMID 39430759 · DOI 10.3389/fimmu.2024.1441667
8. 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