Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00083031|
Recruitment Status : Completed
First Posted : May 17, 2004
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: bevacizumab Drug: cyclophosphamide Drug: methotrexate||Phase 2|
This study uses an investigational drug called Bevacizumab. Investigational means that this drug is not approved by the Federal Drug Administration and is still being studied. Bevacizumab is the common name for the commercial drug Avastin. The Bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing, and are expected to be very similar in safety and effectiveness.
The purpose of this study is to find out what effects (good and bad) low-dose continuous chemotherapy (referred to as metronomic chemotherapy) using drugs Cytoxan (also called cyclophosphamide) and methotrexate (CM), with or without bevacizumab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metronomic Chemotherapy With Bevacizumab for Advanced Breast Cancer|
|Actual Study Start Date :||July 2003|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2009|
Experimental: Arm A-Bevacizumab
Other Name: Avastin
Experimental: Arm B- Without Bevacizumab
- Objective Response Rate (ORR) [ Time Frame: Disease evaluations occurred every 8 weeks for the first 6 cycles and every 12 weeks thereafter until progression, death or lost-to-follow-up. Patients were followed for ORR up to approximately 1 year. ]ORR is the proportion of patients achieving Complete Response (CR) or Partial Response (PR) based on RECIST 1.0 criteria: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
- Progression-Free Survival (PFS) [ Time Frame: Disease evaluations occurred every 8 weeks for the first 6 cycles and every 12 weeks thereafter until progression, death or lost-to-follow-up. Patients were followed for PFS up to approximately 1 year. ]PFS based on the Kaplan-Meier method is defined as the time from study entry and documented disease progression (PD) per RECIST 1.0 criteria or death. Patients alive without progression are censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
- Overall Survival (OS) [ Time Frame: Patients were followed until death or lost-to-follow-up. Patients were followed for OS up to approximately 4 years. ]OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
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): NCT00083031
|United States, Massachusetts|
|Massachusetts General Hosptial|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Harold J. Burstein, MD, PhD||Dana-Farber Cancer Institute|