Evidence map›Paper›PMID 40504550›Full record

Trial reportThe oncologist2025

Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial.

Lichen Tang, Min He, Cuizhi Geng, Zhimin Fan, Rui Ling, Guangdong Qiao, Li Cai, Ting Luo, Feng Jin, Haibo Wang and 7 more

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

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03949634 (Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin（PLD）：an Dynamic Randomized, Positive Control, Open, Multicenter Clinical Study), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03949634 phase3unknown statusnot on this map

Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin（PLD）：an Dynamic Randomized, Positive Control, Open, Multicenter Clinical Study

TypeinterventionalSponsorFudan UniversityRan2017 to 2020Enrolled272ConditionsEarly Breast CancerArmsPLD, CTX, Docetaxel, Paclitaxel, Doxorubicin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Liposomal nanotherapeutics for cancer treatment: Targeted delivery and immunotherapy.International journal of immunopathology and pharmacology
    Review
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

17 authors.

Lichen TangDepartment of Breast Surgery, Fudan University Shanghai Cancer Center and Key Laboratory of Breast Cancer in Shanghai, Shanghai, People's Republic of China.
Min HeDepartment of Breast Surgery, Fudan University Shanghai Cancer Center and Key Laboratory of Breast Cancer in Shanghai, Shanghai, People's Republic of China.
Cuizhi GengDepartment of Breast Center, the Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China.
Zhimin FanDepartment of Breast Surgery, Bethune First Hospital of Jilin University, Changchun, People's Republic of China.
Rui LingDepartment of Thyroid and Breast surgery, Xijing Hospital of Air Force Military Medical University, Xi'an, People's Republic of China.
Guangdong QiaoDepartment of Breast Surgery, Yantai Yuhuangding Hospital, Yantai, People's Republic of China.ORCID 0000-0002-5298-3411
Li CaiDepartment of Breast Medicine, Harbin Medical University Cancer Hospital, Harbin, People's Republic of China.
Ting LuoDepartment of Breast Center, West China Hospital of Sichuan University, Chengdu, People's Republic of China.
Feng JinDepartment of Breast Surgery, The First Hospital of China Medical University, Shenyang, People's Republic of China.
Haibo WangBreast Disease Diagnosis and Treatment Center, The Affiliated Hospital of Qingdao University, Qingdao, People's Republic of China.
Anqin ZhangBreast Disease Prevention and Treatment Center, Guangdong Women and Children Hospital, Guangzhou, People's Republic of China.
Hongwei ZhangDepartment of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Xiaohua ZengBreast Cancer Center, Chongqing University Cancer Hospital, Chongqing, People's Republic of China.
Xiaojia WangDepartment of Breast Medicine, Cancer Hospital of The University of Chinese Academy of Sciences Zhejiang Cancer Hospital, Hangzhou, People's Republic of China.
Ming JiangDepartment of Thyroid and Breast Surgery, The Central Hospital of Wuhan, Wuhan, People's Republic of China.
Zhonghua WangDepartment of Breast Surgery, Fudan University Shanghai Cancer Center and Key Laboratory of Breast Cancer in Shanghai, Shanghai, People's Republic of China.ORCID 0000-0001-8792-3753
Zhimin ShaoDepartment of Breast Surgery, Fudan University Shanghai Cancer Center and Key Laboratory of Breast Cancer in Shanghai, Shanghai, People's Republic of China.

Funding

Shanghai Cancer Hospital, Fudan University
6 · The paper itself

Abstract

backgroundPegylated liposomal doxorubicin (PLD) was shown to have comparable efficacy to doxorubicin, with significantly reduced cardiotoxicity. This study evaluated the cardiotoxicity and efficacy of the PLD-based regimen compared with those of the doxorubicin-based regimen as adjuvant therapy for early-stage breast cancer (BC).

methodsIn this open-label, randomized controlled trial, patients with early-stage BC were assigned to receive either 4 cycles of PLD (study group) or doxorubicin (control group) plus cyclophosphamide followed by 4 cycles of docetaxel/paclitaxel. The primary endpoint was cardiotoxicity.

resultsBetween November 2017 and September 2019, 247 patients (study group, n = 131; control group, n = 116) were enrolled. Incidence rates of abnormal left ventricular ejection fraction (LVEF, 0 vs. 1.7%) and congestive heart failure (0.0% vs. 0.9%) were similar between the two groups (all P > 0.05). A lower proportion of elevated high-sensitivity cardiac troponin T (3.8% vs. 30.2%, P < 0.001) was observed in the study group. The 5-year disease-free survival (82.7% vs. 83.8%) and overall survival (90.4% vs. 91.6%) rates were comparable (all P > 0.05). Grade 3-4 adverse events in the study group were significantly less than in the control group (43.5% vs. 61.2%, P = 0.005).

conclusionThe PLD-based regimen for early-stage BC showed significantly lower rates of elevated hs-cTnT and grade 3-4 AEs with comparable efficacy to the doxorubicin-based regimen. (ClinicalTrials.gov Identifier: NCT03949634; IRB Approved: Ethics committee institutional review board of Shanghai Cancer Hospital, Fudan University's (No. 1706173-19-1904B) and other center).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDoxorubicinTaxoidsAdultAgedBridged-Ring CompoundsCardiotoxicityChemotherapy, AdjuvantFemaleHumansMiddle AgedNeoplasm StagingPolyethylene GlycolsBridged-Ring CompoundsCyclophosphamideDoxorubicinliposomal doxorubicinPolyethylene GlycolstaxaneTaxoidsadjuvant therapycardiotoxicityearly-stage breast cancerefficacypegylated liposomal doxorubicin

Identifiers

PMID40504550
PMCPMC12160816

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.