Low -Dose-bevacizumab and Pemetrexed Versus TPC in Metastatic HER2-negative Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02829008|
Recruitment Status : Unknown
Verified July 2016 by Li Qiao, Chinese Academy of Medical Sciences.
Recruitment status was: Active, not recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: low-dose-bevacizumab/pemetrexed Drug: Treatment of physician's choice||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Clinical Trial:Low -Dose-bevacizumab and Pemetrexed Versus Treatment of Physician's Choice in Metastatic HER2-negative Breast Cancer Patients After Failure of Taxanes and Anthracycline-containing Regimens|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2020|
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.
Bevacizumab is administrated at a dose of 2 mg/kg once weekly by intravenous transfusion, which is on day 1, 8 and 15, and pemetrexed is given at a dose of 500mg/m2 once on the first day by intravenous transfusion, and repeated every three weeks, too.
Other Name: Avastin/ALIMTA
Active Comparator: Treatment of physician' choice
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.
Drug: Treatment of physician's choice
The clinicians can select any drug or regimen that has been approved in metastatic cancer at present, including monotherapy, combination therapy, target therapy and palliative therapy. Specific agents include taxanes, capecitabine, gemcitabine, vinorelbine, cisplatin,carboplatin, nutrient solutions, and so on. These agents can be administered as monotherapy or in combination.
Other Name: any drug or regimen approved in metastatic cancer
- Objective response rare (ORR) [ Time Frame: up to 24 months ]Evaluated as complete remission(CR) and partial remission(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1
- progression free survival(PFS) [ Time Frame: up to 48 months ]
- Overall survival(OS) [ Time Frame: up to 48 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829008
|Cancer Hospital, ChineseAMS|
|Beijing, Beijing, China, 100021|
|Principal Investigator:||Binghe Xu, MD.||Chinese Academy of Medical Sciences|