- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978977
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer
October 6, 2015 updated by: Hellenic Oncology Research Group
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.
Study Overview
Status
Completed
Conditions
Detailed Description
Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival.
There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandroupolis, Greece
- University General Hospital of Alexandroupolis, Dept. of Medical Oncology
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Athens, Greece
- Air Forces Military Hospital of Athens
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Athens, Greece
- "IASO" General Hospital of Athens
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Piraeus, Greece
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Thessaloniki, Greece
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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Crete
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Heraklion, Crete, Greece
- University Hospital of Crete, Dep of Medical Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Clinics for cancer prevention
Description
Inclusion Criteria:
- Written informed consent
- Age ≥18 years
- Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
- No prior first line treatment for metastatic Breast Cancer
- Previous hormonotherapy for metastatic Breast Cancer is allowed
- One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
- ECOG performance status ≤2
- Adequate haematological, renal and hepatic function
- Urine protein <2+ (dipstick)
- Life expectancy of ≥12 weeks
Exclusion Criteria:
- Previous first line treatment for metastatic colorectal cancer(progression >12 months after the end of adjuvant treatment)
- Previous radiotherapy to target lesions
- Patients with brain metastases and/or cancerous meningitis
- Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
- Patients participating in interventional clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Avastin regimens
Patients who are going to receive chemotherapy plus Avastin (bevacizumab)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events
Time Frame: Every 2 or 3 weeks up to 12 or 18 weeks
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In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks
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Every 2 or 3 weeks up to 12 or 18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients with Progression Free Survival
Time Frame: 1 year
|
1 year
|
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Patients Overall Survival
Time Frame: 1 year
|
1 year
|
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Number of Participants with Response Rate
Time Frame: Disease evaluation at Week 3 or at week 6
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In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 or 6 weeks
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Disease evaluation at Week 3 or at week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vassilis Georgoulias, MD, Hellenic Oncology Research Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
November 3, 2013
First Submitted That Met QC Criteria
November 3, 2013
First Posted (Estimate)
November 8, 2013
Study Record Updates
Last Update Posted (Estimate)
October 7, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT/10.17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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