Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer
- Registration Number
- NCT01120158
- Lead Sponsor
- Hellenic Oncology Research Group
- Brief Summary
This study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.
- Detailed Description
Elderly individuals make up a large part of the breast cancer population. Older women are more likely than younger women to be diagnosed at a more advanced stage of breast cancer. However, when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Preference should be given to chemotherapeutic drugs with safer profiles regimens, such as weekly taxane, according to the SIOG recommendations. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 46
- Histologically or cytologically confirmed metastatic breast adenocarcinoma
- No previous therapy (other than hormonal therapy) for metastatic disease is accepted
- 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
- 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 non-melanoma skin cancer
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Bevacizumab Paclitaxel/Bevacizumab 1 Paclitaxel Paclitaxel/Bevacizumab
- Primary Outcome Measures
Name Time Method Overall Response Rate Objective responses confirmed by CT or MRI every 3 months
- Secondary Outcome Measures
Name Time Method Overall Survival 1 year Toxicity profile Toxicity assessment every month Time to Tumor Progression 1-year
Trial Locations
- Locations (11)
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
🇬🇷Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
🇬🇷Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
🇬🇷Larissa, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
🇬🇷Athens, Greece
Air Forces Military Hospital of Athens
🇬🇷Athens, Greece
University General Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
🇬🇷Athens, Greece
401 Military Hospital of Athens
🇬🇷Athens, Greece
University Hospital of Crete
🇬🇷Heraklion, Greece
"Diabalkaniko" hospital, Thessaloniki
🇬🇷Thessaloniki, Greece
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
🇬🇷Thessaloniki, Greece