Evidence map›Paper›PMID 35321427›Full record

ArticleFrontiers in oncology2022

Dalpiciclib Combined With Pyrotinib and Letrozole in Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer (LORDSHIPS): A Phase Ib Study.

Jian Zhang, Yanchun Meng, Biyun Wang, Leiping Wang, Jun Cao, Zhonghua Tao, Ting Li, Wenqing Yao, Xichun Hu

2 registry-linked trialsAbstract read
In one paragraph

Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

NCT03772353 phase1 / phase2unknown statusnot on this map

Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer: a Multi-center Phase Ib/II Study

TypeinterventionalSponsorFudan UniversityRan2019 to 2025Enrolled59ConditionsBreast CancerArmsDalpiciclib, Pyrotinib, Letrozole, Fulvestrant
NCT06235931 narecruitingnot on this mapstarted 2024, after this paper: background citation

Prospective, Single-arm, Single-center Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of Elderly Advanced Triple-positive Breast Cancer.

TypeinterventionalSponsorSecond Affiliated Hospital of Soochow UniversityRan2024 to 2026Enrolled34ConditionsBreast NeoplasmsArmsDarcilide +AI (letrozole/anastrozole/Exemestane) + pyrrotinib
3 · Its place in the literature

Who cites it

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

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  8. Chinese expert consensus on endocrine therapy for breast cancer (2026 edition).Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
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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

9 authors.

Jian ZhangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Yanchun MengDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Biyun WangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Leiping WangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Jun CaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Zhonghua TaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Ting LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Wenqing YaoDepartment of Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Xichun HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The LORDSHIPS study aimed to explore the safety and efficacy of a novel fully oral triplet combination of dalpiciclib (a potent cyclin-dependent kinase 4/6 inhibitor), pyrotinib (a HER2 tyrosine kinase inhibitor) and endocrine therapy letrozole in patients with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer (MBC) in the front-line setting. Patients and Methods: Postmenopausal women with HER2-positive, HR-positive MBC were recruited in the dose-finding phase Ib trial. A standard 3 + 3 design was used to determine safety, tolerability, and recommended phase II dose (RP2D) for the combination. Results: A total of 15 patients were enrolled to three dose combination cohorts (letrozole/pyrotinib/dalpiciclib, level/I: 2.5/400/125 mg, n=5; level/L1: 2.5/400/100 mg, n=6; level/L2: 2.5/320/125 mg, n=4). Three patients experienced dose-limiting toxicities (level/I, n=2; level/L1, n=1) and level/L2 was identified as RP2D. The most frequent grade 3-4 adverse events were neutropenia (46.7%), leukopenia (40.0%), oral mucositis (26.7%) and diarrhea (20.0%). The confirmed objective response rate (ORR) was 66.7% (95% CI: 38.4% to 88.2%). The confirmed ORR of study treatment as first line (1L) and second line (2L) HER2-targeted therapy was 85.7% (6/7) and 50.0% (4/8), respectively. Median progression-free survival (PFS) was 11.3 months (95% CI: 5.3 months to not reached). PFS in 1L setting was not reached yet, while PFS in 2L setting was 10.9 months (95% CI: 1.8 to 13.7 months). Conclusions: The fully oral combination of dalpiciclib, pyrotinib and letrozole is a promising chemotherapy-sparing treatment option for HER2-positive, HR-positive MBC patients. The planned dose-expansion phase II study is ongoing. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT03772353.

Indexed as

CDK4/6 inhibitorendocrine therapyHER2-positivehormone receptor-positivemetastatic breast cancerpyrotinib

Identifiers

PMID35321427
PMCPMC8936075

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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.