Evidence map›Paper›PMID 40541191›Full record

Trial reportCell reports. Medicine2025

Neoadjuvant anlotinib/sintilimab plus chemotherapy in triple-negative breast cancer (NeoSACT): Phase 2 trial.

Liulu Zhang, Lu Yang, Yan Ge, Zhaowen Zhu, Bo Chen, Ciqiu Yang, Hongfei Gao, Mei Yang, Teng Zhu, Kun Wang

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cell reports. Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04877821 (An Open-label Phase II Trial Evaluating the Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer(NeoSACT)), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04877821 phase2completednot on this map

An Open-label Phase II Trial Evaluating the Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer(NeoSACT)

TypeinterventionalSponsorGuangdong Provincial People's HospitalRan2021 to 2026Enrolled29ConditionsTriple Negative Breast CancerArmsSintilimab, Anlotinib, Nab paclitaxel, Carboplatin, Epirubicin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
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  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Liulu ZhangDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Lu YangDepartment of Radiotherapy, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Yan GeDepartment of Pathology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Zhaowen ZhuDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Bo ChenDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Ciqiu YangDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Hongfei GaoDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Mei YangDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Teng ZhuDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Kun WangDepartment of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China. Electronic address: wangkun@gdph.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tumor angiogenesis contributes to immune evasion, and vascular normalization enhances immunotherapy response by reshaping the tumor microenvironment. This phase 2 trial evaluates neoadjuvant anlotinib (antiangiogenic), sintilimab (programmed cell death protein 1 [PD-1] inhibitor), and chemotherapy in 29 patients with stage II-III triple-negative breast cancer (TNBC). The primary endpoint, pathological complete response (pCR), is achieved in 69.0% (95% confidence interval [CI]: 49.0%-85.0%), with an 86.2% minimal residual disease (residual cancer burden [RCB] 0 + 1) rate. Notably, programmed death-ligand 1 (PD-L1)-negative patients achieve a 75.0% pCR rate, comparable to PD-L1-positive patients (64.7%). The 2-year event-free survival (EFS) is 92.4%, with 100% EFS in pCR patients. Grade 3/4 adverse events occur in 31.0% of patients, primarily rash and hematologic toxicities. These results demonstrate that combining antiangiogenic therapy with immunotherapy and chemotherapy enhances treatment efficacy, potentially overcoming PD-L1 limitations, and supports further investigation in high-risk TNBC. This trial was registered at ClinicalTrials.gov (NCT04877821).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsIndolesNeoadjuvant TherapyQuinolinesTriple Negative Breast NeoplasmsAdultAgedB7-H1 AntigenFemaleHumansMiddle AgedTreatment OutcomeanlotinibAntibodies, Monoclonal, HumanizedB7-H1 AntigenIndolesQuinolinessintilimabantiangiogenesisimmune checkpoint inhibitorneoadjuvant therapypathological complete responsetriple-negative breast cancer

Identifiers

PMID40541191
PMCPMC12281363

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.