BMC complementary medicine and therapies · 2026
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.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Hao Wei, Sun Chenping, Wu Chunyu, Shi Youyang, Qin Yuenong, Liu Sheng
Аннотация
BACKGROUND: Human 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.
METHOD: In 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 REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2200061011).
METHOD: In 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 REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2200061011).