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EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer

RecruitingPhase 3Ages 18 Years - 70 YearsFemaleFudan University
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In plain words

What the trial is, and whether it could suit you

compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Women aged 18-70; * 0-1 for ECOG; * Unilateral invasive carcinoma confirmed by histology (regardless of pathological type); * No gross or microscopic tumor remains after surgical resection; * Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive; * Postoperative pathological stage pT1-4N1-3M0; * Did not receive neoadjuvant chemotherapy in the past; * The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery; * No peripheral neuropathy; * Good postoperative recovery, at least 1 week interval between operation; * The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN; * Contraception during treatment for women of reproductive age; * Cardiac function: LVEF\>50% for ultrasound examination; * The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。 Exclusion Criteria: * Bilateral breast cancer or carcinoma in situ DCIS/LCIS; * Have received chemotherapy for advanced disease; * Transfer of any part; * If any tumor \>T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer); * Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy; * Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy; * Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years; * The patient has been enrolled in other clinical trials; * Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study; * LVEF\<50% (cardiac ultrasound); * Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization; * Known allergy to related drugs; * Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment; * Pregnant and lactating women; * Those who tested positive for pregnancy before taking the drug after joining the trial; * Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ;(systematic evaluation is required before trial enrollment); * Persons without personal freedom and independent capacity for civil conduct。
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What it tests

  • Docetaxel
  • carboplatin
  • Trastuzumab
  • Pertuzumab
  • Epirubicin
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Where

1 site
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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