May 29, 2008 |
April 13, 2009 |
April 2008 |
Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00691379 on ClinicalTrials.gov Archive Site |
- Toxicity profile [ Time Frame: Toxicity assessment of each chemotherapy cycle ] [ Designated as safety issue: Yes ]
- Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|
Same as current |
|
Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer |
Weekly Paclitaxel-Carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study |
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 |
Phase I, Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Breast Cancer |
- Drug: Carboplatin
- Drug: Bevacizumab
- Drug: Paclitaxel
|
Experimental: Paclitaxel/Carboplatin/Bevacizumab |
|
|
Recruiting |
46 |
April 2010 |
April 2010 (final data collection date for primary outcome measure) |
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
|
Female |
18 Years to 75 Years |
No |
|
Greece |
|
|
NCT00691379 |
D.Mavrudis, University Hospital of Crete |
|
Hellenic Oncology Research Group |
University Hospital of Crete |
Principal Investigator: |
Dimitris Mavrudis, MD |
University Hospital of Crete |
|
|
Hellenic Oncology Research Group |
April 2009 |