Status:
COMPLETED
Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the ...
Detailed Description
Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic breast adenocarcinoma
- No HER2 overexpression or gene amplification
- Absent or low ER or PR expression
- No previous therapy for metastatic breast cancer is allowed
- Age 18-75 years
- Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
- Performance status (WHO) 0-2
- Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases)
- adequate renal function (serum creatinine \<1.5 times the upper normal limit)
- bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
- No radiation of measurable disease (except brain metastases)
- No progressive brain metastases according to clinical or radiological criteria
- No brain metastases without prior radiation therapy
- Written informed consent
Exclusion
- Active infection
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- History of stroke
- Anticoagulation therapy (except of low dose aspirin \<325mg)
- Other invasive malignancy except nonmelanoma skin cancer
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00691379
Start Date
April 1 2008
End Date
March 1 2016
Last Update
September 22 2016
Active Locations (11)
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1
University General Hospital of Alexandroupolis
Alexandroupoli, Greece
2
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece