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 efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population
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 are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
University General Hospital of Alexandroupolis
Alexandroupoli, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
Overall Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Toxicity profile
Time frame: Toxicity assessment of each chemotherapy cycle
Time to Tumor Progression
Time frame: 1-year
Overall Survival
Time frame: 1 year
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"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
University Hospital of Crete
Heraklion, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Diabalkaniko" hospital, Thessaloniki
Thessaloniki, Greece
...and 1 more locations