Evidence map›Paper›PMID 39948624›Full record

Trial reportBreast cancer research : BCR2025

Clinical efficacy and therapy response prediction of neoadjuvant dalpiciclib plus letrozole in postmenopausal patients with HR+/HER2- stage II-III breast cancer (DARLING 01): a single-arm, open-label, exploratory study.

Lina Zhang, Yueping Liu, Chao Yang, Jie Ma, Yuntao Li, Ruizhen Luo, Jianjun Han, Xiaochun Wang, Zhisheng Zhang, Li Ma and 9 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research : BCR, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05512780 (An Exploratory Clinical Study of CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT05512780 phase2unknown statusnot on this map

An Exploratory Clinical Study of CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

TypeinterventionalSponsorHebei Medical University Fourth HospitalRan2022 to 2024Enrolled30ConditionsSolid TumorArmsDalpiciclib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
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

19 authors.

Lina ZhangDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Yueping LiuDepartment of Pathology, The Fourth Hospital of Hebei Medical University, Hebei, China.
Chao YangDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Jie MaDepartment of Breast Surgery, TangShan People's Hospital, Tangshan, China.
Yuntao LiDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Ruizhen LuoDepartment of Breast Surgery, Hebei Province CangZhou Hospital of Integrated Traditional and Western Medicine, Hebei, China.
Jianjun HanDepartment of Breast Surgery, Affiliated Hospital of Hebei University of Engineering, Hebei, China.
Xiaochun WangDepartment of Breast Surgery, Affiliated Hospital of Hebei University, Hebei, China.
Zhisheng ZhangDepartment of Breast Surgery, The First Affiliated Hospital of Hebei North University, Hebei, China.
Li MaDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Haifeng CaiDepartment of Breast Surgery, TangShan People's Hospital, Tangshan, China.
Xiangshun KongDepartment of Breast Surgery, Xingtai People's Hospital, Hebei, China.
Zunyi WangDepartment of Breast Surgery, Cangzhou Central Hospital, Hebei, China.
Xinping ZhouDepartment of General surgery, HanDan Central Hospital, Hebei, China.
Jiajie ShiDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Yanshou ZhangDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Meiqi WangDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Jiaxing WangDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China.
Cuizhi GengDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Hebei, 050011, China. 46300349@hebmu.edu.cn.

Funding

Beijing Xisike Clinical Oncology Research Foundation Y-HR2022ZD-0772
6 · The paper itself

Abstract

backgroundHormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common subtype of breast cancer, yet its response to traditional chemotherapy remains limited, posing a challenge in achieving optimal therapeutic outcomes. In this study, we aimed to evaluate the clinical efficacy and safety of dalpiciclib, a novel CDK4/6 inhibitor, combined with letrozole as neoadjuvant therapy (NAT) in postmenopausal patients with HR+/HER2- stage II-III breast cancer. Additionally, we explored potential predictive biomarkers for treatment response using gene analysis.

methodsThis single-arm, open-label, exploratory phase II trial involved 35 postmenopausal women with HR+/HER2- breast cancer (ClinicalTrials.gov identifier NCT05512780). Patients received four cycles of dalpiciclib (125 mg/day for 3 weeks, followed by 1 week off) plus continuous letrozole (2.5 mg/day). The primary endpoint was objective response rate (ORR), and secondary endpoints included changes in Ki-67 expression, complete cell cycle arrest (CCCA) rate, residual cancer burden (RCB), and safety profiles. Gene expression profiling and least absolute shrinkage and selection operator (LASSO) regression were conducted to identify biomarkers predictive of response to NAT.

resultsAmong the 35 enrolled patients, 31 completed the full treatment course. Of the 29 patients with evaluable response data after 4 cycles, 16 achieved partial response (PR), resulting in an ORR of 55.2%. Following two weeks of treatment, the mean Ki-67 expression significantly decreased from a baseline of 17.5-1.8%, and CCCA was observed in 75% of patients. Grade ≥ 3 treatment-emergent adverse events (TEAEs) were mainly decreased neutrophil count (45.7%), with a median duration of 3 days. The NAT predictive model, developed using gene expression analysis and clinicopathological factors, achieved an area under the curve (AUC) of 0.928, indicating that TFRC, SCUBE2, and MMP11A could serve as novel predictive biomarkers for response to NAT.

conclusionsDalpiciclib combined with letrozole demonstrated promising antitumor activity and an acceptable safety profile in postmenopausal patients with HR+/HER2- breast cancer. The identification of TFRC, SCUBE2, and MMP11A as predictive biomarkers provides insights into the potential for personalized neoadjuvant treatment strategies.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsAgedBiomarkers, TumorErb-b2 Receptor Tyrosine KinasesFemaleHumansLetrozoleMiddle AgedNeoadjuvant TherapyNeoplasm StagingPiperidinesPostmenopausePyridinesPyrimidinesReceptors, EstrogenBiomarkers, TumordalpiciclibERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozolePiperidinesPyridinesPyrimidinesReceptors, EstrogenReceptors, ProgesteroneDalpiciclibHR+/HER2- breast cancerNeoadjuvant endocrine therapyPredictive biomarkers

Identifiers

PMID39948624
PMCPMC11827216

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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.