ec-thp versus tcbhp in her2-positive lymph node positive early breast cancer

Conditions: HER2 Positive Early Breast Cancer

Summary: compare the efficacy and safety of tcbhp and ec-thp regimen in her2-positive breast cancer patients

the objective of this study is to conduct a randomized controlled clinical study to compare the efficacy and safety of tcbhp and ec-thp regimen in her2-positive breast cancer patients, so as to further optimize adjuvant chemotherapy regimen for breast cancer.

Eligibility criteria:
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。