Cardiotoxicity Induced by Drug Therapy for Breast Cancer
Investigational drug(s) / intervention(s)
Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The incidence of cardiotoxicity in the treatment group and control group — From 1 week before enrollment to 1.5 years after the start of trastuzumab treatment. Calculate the incidence of cardiotoxicity associated with anthracycline sequential trastuzumab treatment of two groups.Cardiotoxicity is defined as the occurrence of symptomatic congestive heart failure, or a decrease in left ventricular ejection fraction (LVEF) without clinical symptoms that meets one of the following conditions: ① a decrease of ≥ 15% in LVEF from baseline after anti-cancer treatment; ② After anti-cancer treatment, LVEF decreased by ≥ 10% from baseline and the monitoring value was\<50%; ③ LVEF monitoring value after anti-cancer treatment is less than 45%. The definition of symptomatic congestive heart failure includes but is not limited to any one or more of the following: moist rales in the lungs, anterior tibial edema in both lower limbs, and cyanosis of the lips.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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