Breast Cancer
Conditions
Keywords
Breast cancer, Triple negative, Chemotherapy, Anti-angiogenesis therapy
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 efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population
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 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
Interventions
DRUGCarboplatin
Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
DRUGBevacizumab
Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
DRUGPaclitaxel
Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity profile | Toxicity assessment of each chemotherapy cycle |
| Time to Tumor Progression | 1-year |
| Overall Survival | 1 year |
Countries
Greece
Outcome results
None listed