Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

Korábbi kezelés

• Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
• Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;

Más betegség

• Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
• Patients with severe systemic infection or other serious diseases;
• Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
• Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;

Életkor

• Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;

Egyéb

• The researchers considered the patients who were not suitable for enrollment.

• Females with age between 18 to 70 years old;
• Histologically confirmed primary invasive breast cancer;
• Histologically confirmed triple negative breast cancer;
• Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
• Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
• Have at least one measurable lesion as per the RECIST criteria (version 1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
• LVEF≥55%；
• Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
• Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
• Patients had good compliance with the planned treatment, understood the research process and written informed consent.