Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

Korábbi kezelés

• 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 required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
• 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;

Laborértékek

• Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;

Életkor

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

Egyéb

• Brain metastasis;
• Recurrence or metastasis within 6 months after capecitabine withdrawal;
• Recurrence or metastasis within 6 months after platinum withdrawal;
• Patients who had Grade 2 or above Peripheral neuropathy;
• The researchers considered the patients who were not suitable for enrollment.

• Females with age between 18 to 70 years old;
• Histologically confirmed triple negative breast cancer;
• No more than one-line prior treatment for locally advanced or metastatic breast cancer;
• 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;
• Patients with life expectancy of at least 3 months;
• 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.