Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Triple Negative Breast Cancer, Nab-paclitaxel
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Nab-paclitaxel, Carboplatin, Capecitabine, Triple Negative Breast Cancer, Maintenance therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- Brain metastasis;
- Recurrence or metastasis within 6 months after capecitabine withdrawal;
- Recurrence or metastasis within 6 months after platinum withdrawal;
- Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
- Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
- Patients who had Grade 2 or above Peripheral neuropathy;
- 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;
- Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
- Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
- The researchers considered the patients who were not suitable for enrollment.
Sites / Locations
- The Fourth Hospital of Hebei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Nab-paclitaxel + Carboplatin
Nab-paclitaxel + Capecitabine
Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles; Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;
Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles; Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;