The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity

Trial Title: The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity

NCT ID: NCT06214195

Condition: Cardiotoxicity Induced by Drug Therapy for Breast Cancer

Conditions: Official terms:
Cardiotoxicity

Conditions: Keywords:
prevent
cardiotoxicity
trastuzumab
chemotherapy
anthracycline

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: The risk exposure factors for the experimental group and the control group are the same

Primary purpose: Prevention

Masking: None (Open Label)

Masking description: Open Label

Intervention:

Intervention type: Drug
Intervention name: Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)
Description: Ginseng 6g , Ophiopogon japonicus 12g ,Schisandra chinensis 5g , other secondary Chinese medicines can be added according to the doctor's judgment and the patient's condition，decoction in water, one dose and two decoctions, taken twice a day, continuously for 7 days from the start of each chemotherapy cycle (± 3 days), including anthracyclines and taxanes (the frequency and dosage of medication can be adjusted according to adverse reactions in the later stage); The total duration of medication interventionis 7 days per cycle, with a total of 8 cycles. If the chemotherapy is less than 8 cycles, continue taking for 7 consecutive days from the start of each subsequent trastuzumab cycle (the frequency and dosage can be adjusted based on adverse reactions) until a total of 8 cycles are reached.
Arm group label: treatment group

Summary: To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.

Detailed description: This study is a randomized, controlled, open-label prospective clinical study. This study adopts an optimal design, with the main evaluation indicator being the incidence of cardiac toxicity. Patients who passed the inclusion and exclusion criteria through clinical research were randomly assigned to the experimental group and control group. Experimental(treatment)group: received preventive treatment with Shengmai Powder，and may also receive additional Chinese medicines based on the doctor's judgment and the patient's condition.Control group: during chemotherapy and trastuzumab administration, no Chinese medicine with ginseng, ophiopogon japonicus and schisandra chinensis as ingredients or western medicine with heart strengthening or heart protection function were used. During the treatment process, cardiac function related indicators such as symptomatic congestive heart failure or asymptomatic but decreased left ventricular ejection fraction (LVEF) are evaluated to determine the occurrence of cardiac toxicity.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Non metastatic primary invasive HER2 positive breast cancer stage I-III invasive HER2 positive breast cancer is defined as the tumor invasive component HER2 immunohistochemical IHC+++or IHC++confirmed to be HER2 positive by fluorescence in situ hybridization 2. Plan to use AC sequential TH (P) adjuvant or neoadjuvant chemotherapy with anthracycline containing chemotherapy regimens (A is doxorubicin or epirubicin, C is cyclophosphamide, T is paclitaxel, liposome paclitaxel, albumin bound paclitaxel or docetaxel, H is trastuzumab, which can be combined with pertuzumab (P))，and before using anthracycline drugs, the left ventricular ejection fraction (LVEF) should be ≥ 50% 3. Plan to use trastuzumab or trastuzumab combined with pertuzumab for one year of treatment； 4. ECOG PS: 0-1 points； 5. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study, and sign a written informed consent form. Exclusion Criteria: 1. The New York Heart Association (NYHA) classifies patients with heart disease at or above Level II (including Level II) 2. Severe heart disease or discomfort, including high-risk uncontrolled arrhythmia, etc 3. There are contraindications or intolerance to treatment with trastuzumab, including allergies to trastuzumab, and the presence of underlying heart diseases that cannot be treated with trastuzumab as determined by a specialist 4. Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis 5. Unable to cooperate with treatment and follow-up.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Ping Huang

Phone: +86-13685766632
Email: zlyyhp@163.com

Contact backup:
Last name: Zhanhong Chen

Phone: +86-13606505124
Email: czred@sina.com

Investigator:
Last name: Ping Huang
Email: Principal Investigator

Start date: January 20, 2024

Completion date: December 1, 2030

Lead sponsor:
Agency: Zhejiang Cancer Hospital
Agency class: Other

Source: Zhejiang Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06214195