Low -Dose-bevacizumab and Pemetrexed Versus TPC in Metastatic HER2-negative Breast Cancer Patients
Metastatic Breast Cancer
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring HER2 negative breast cancer, low-dose bevacizumab, pemetrexed
Eligibility Criteria
Inclusion Criteria:
- Metastatic breast cancer females confirmed by pathological and/or cytological examination;
- Breast cancer patients who received taxanes and anthracycline-containing regimens previously;
- HER2-negative breast cancer patients confirmed by immunohistochemical test or fluorescent in situ hybridization(FISH);
- Patients aged from 18-70 years old, and patients with Eastern Cooperative Oncology Group(ECOG) performance status scored 0-2;
- One or more measurable lesions in imaging examination,with a diameter no less than 20mm in ordinary computed tomography (CT) or magnetic resonance imaging (MRI), or a scanning diameter no less than 10mm in spiral CT;
- Any other kind of concomitant chemotherapy is not allowed during the research. If the patients had accepted other chemotherapy before recruitment, he can enter into the study until the drug is eliminated 30 days later;
- Patients without any kind of major organ dysfunction: normal blood test results, normal function of heart, liver, kidney, marrow and so on.
Exclusion Criteria:
- Patients who had received any chemotherapy, radiotherapy, biotherapy, or drugs and physical treatment in other clinical trials four weeks within the enrollment;
- Patients who has no measurable or assessable lesions ;
- Patients with moderate or severe liver dysfunction
- Pregnant or lactational patients;
- Patients with severe complications, including severe heart disease, cerebrovascular disease, uncontrolled diabet and hypertension, severe infection , active peptic ulcer and so on;
- Patient who had previously received pemetrexed-containing regimens in metastatic setting.
Sites / Locations
- Cancer Hospital, ChineseAMS
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
low-dose-bevacizumab/Pemetrexed
Treatment of physician' choice
Low-dose-bevacizumab is given at a dose of 2 mg/kg once weekly by intravenous transfusion, which is on day 1, 8 and 15, and every three weeks are a treatment cycle .Pemetrexed is given at a dose of 500mg/m2 once on the first day by intravenous transfusion, and repeated every three weeks, too. The pretreatment of pemetrexed should be conducted within the study.
Treatment of physician's choice can be any drug or regimen that has been approved in metastatic cancer at present, including monotherapy, combination therapy, target therapy and palliative therapy. It can be drugs like taxanes,capecitabine, gemcitabine, cisplatin, everolimus or even nutrient solution,et al.