RECRUITINGPhase 3INTERVENTIONAL

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

Clinical Study on the Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China