Evidence map›Paper›PMID 42116119›Full record

ArticleBMC complementary medicine and therapies2026

Cardioprotective effects of platycodon grandiflorum granules in HER2-positive early breast cancer patients receiving trastuzumab plus pertuzumab: study protocol for a double blind randomized controlled trial.

Wei Hao, Chenping Sun, Chunyu Wu, Youyang Shi, Yuenong Qin, Sheng Liu

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Wei HaoDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, 725 South Wan Ping Road, Shanghai, 200032, China.
Chenping SunDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, 725 South Wan Ping Road, Shanghai, 200032, China.
Chunyu WuDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, 725 South Wan Ping Road, Shanghai, 200032, China.
Youyang ShiDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, 725 South Wan Ping Road, Shanghai, 200032, China.
Yuenong Qin *Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, 725 South Wan Ping Road, Shanghai, 200032, China. frank_yching@aliyun.com.
Sheng Liu *Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, 725 South Wan Ping Road, Shanghai, 200032, China. lsstcm@163.com.

Funding

Aijian Endowment Fund AJ005
6 · The paper itself

Abstract

backgroundHuman epidermal growth factor receptor 2 (HER2)-positive breast cancer is an aggressive subtype. While trastuzumab plus pertuzumab significantly improves outcomes, cardiotoxicity remains a major limitation. Traditional Chinese Medicine (TCM) posits that Platycodon grandiflorus A. DC. (PG) may offer cardioprotection by addressing "Qi deficiency" and "blood stasis". This study aims to investigate the efficacy and safety of PG granules (PGG) in preventing anti-HER2 therapy-associated cardiotoxicity.

methodIn this double-blind, randomized, placebo-controlled trial, approximately 120 patients with HER2-positive early breast cancer initiating trastuzumab and pertuzumab will be randomly assigned (1:1) to receive either PGG or placebo granules for 18 weeks (6 cycles of 3 weeks). The primary outcome is left ventricular ejection fraction (LVEF) measured within 3 days after completing anti-HER2 therapy. Secondary outcomes include: (1) incidence of cardiotoxicity (LVEF decline to < 55% or > 10% drop from baseline), (2) changes in left ventricular global longitudinal strain (GLS), (3) levels of B-type natriuretic peptide (BNP) and troponin I (TnI), (4) incidence of trastuzumab plus pertuzumab interruption due to cardiotoxicity, and (5) event-free survival (EFS) and overall survival (OS). Safety will be monitored according to NCI-CTCAE v4.03. DISCUSSION: This is the first clinical trial evaluating PG for preventing cardiotoxicity induced by trastuzumab plus pertuzumab in HER2-positive early breast cancer. Results will provide essential pilot data for future larger studies on integrative cardioprotective strategies.

trial registrationChinese Clinical Trial Registry (ChiCTR2200061011).

Indexed as

Antibodies, Monoclonal, HumanizedBreast NeoplasmsCardiotonic AgentsCardiotoxicityDrugs, Chinese HerbalPlatycodonTrastuzumabAdultAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedCardiotonic AgentsDrugs, Chinese HerbalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumab

Identifiers

PMID42116119
PMCPMC13334901

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Registered trials

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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.