Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer

Korábbi kezelés

• Has received previous chemotherapy for late stage disease.
• Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy).
• Has previous history of additional malignancy(with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer.
• Has suffered from severe cardiovascular and cerebrovascular diseases disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90 mmHg, myocardial infarction, or cerebrovascular accident.

Más betegség

• Has bilateral breast cancer or bilateral carcinoma in situ.
• Has metastatic (Stage 4) breast cancer.
• Has clinical T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer).
• Has severe systemic disease and/or uncontrolled infection.
• Has known allergy to chemotherapy drugs used in this study.
• Has a history of mental disorders, cognitive impairment, inability to understand the study protocol and side effects, inability to complete the study protocol and follow-up workers (systematic evaluation is required before the patient is enrolled into the study), or is without independent civil capacity.

Laborértékek

• Has insufficient cardiac function: echocardiography showed LVEF< 50%.

Életkor

• Is pregnant, is breast feeding, or is a woman of childbearing age who cannot practice effective contraceptives during treatment and until 8 weeks after the end of treatment.

Egyéb

• Is already participating in another clinical trial.
• Has entered the study, but pre-treatment examination showed a positive pregnancy test.
• The researchers judged patients to be unsuitable for the study.

• Female patients aged 18-70 years old;
• Histologically confirmed unilateral invasive breast cancer (regardless of pathological type)
• Operable breast cancer at first diagnosis, without any absolute surgical contraindication.
• No gross nor microscopic residual tumor after surgery.
• HER2-positive with ≥ 1 positive axillary lymph node; or estrogen receptor (ER) and/or progesterone receptor (PR)-positive and HER2-negative with ≥ 4 positive axillary lymph node. HER2-positive is defined as an immunohistochemistry (IHC) status of 3+, or a positive in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)) test. ER-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were ER positive. PR-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were PR positive.
• Preoperative examination found no evidence of metastasis in clinical examination nor imaging examination.
• No peripheral neuropathy.
• Karnofsky score > 70.
• Good postoperative recovery, at least 1 week has passed since most recent surgery.
• Has adequate bone marrow function: leukocyte count > 4x10ˆ9 / L, absolute neutrophil count > 2x10ˆ9 /L; platelet count > 100x10ˆ9 /L, hemoglobin > 9g/dL.
• Has adequate liver function: alanine aminotransferase (ALT) < 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) < 1.5×ULN, alkaline phosphatase (AKP) < 2.5×ULN, total bilirubin (TBIL) < 1.5×ULN.
• Has adequate kidney function: serum creatinine < 1.5×ULN.
• Contraception during treatment for women of childbearing age.
• Has adequate cardiac function: echocardiography showed left ventricular ejection fraction (LVEF) > 50%.
• Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.