Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00705315 |
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Recruitment Status :
Completed
First Posted : June 26, 2008
Last Update Posted : August 19, 2010
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Sponsor:
Hellenic Oncology Research Group
Information provided by:
Hellenic Oncology Research Group
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Brief Summary:
This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: Docetaxel Drug: Epirubicin Drug: Bevacizumab | Phase 1 Phase 2 |
A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. Recently initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 46 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Docetaxel-epirubicin Plus Bevacizumab as First Line Therapy for Patients With Metastatic and HER2 Negative Breast Cancer. A Multicenter Phase I-II Study |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | June 2010 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Bevacizumab->Epirubicin->Docetaxel
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Drug: Docetaxel
Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles
Other Name: Taxotere Drug: Epirubicin Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles
Other Name: Farmorubicine Drug: Bevacizumab Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles
Other Name: Avastin |
Primary Outcome Measures :
- Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]
Secondary Outcome Measures :
- Toxicity assessment [ Time Frame: Toxicity assessment on each cycle ]
- Time to Tumor Progression [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 1 year ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- No HER2 overexpression or gene amplification
- No previous therapy for metastatic breast cancer is allowed
- Age 18-75 years
- At least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines
- 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 UNL in the presence of liver metastases)
- Adequate renal function (serum creatinine <1.5 times the upper normal limit
- Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
- Written informed consent
Exclusion Criteria:
- Active infection
- Brain metastases
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705315
Locations
| Greece | |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | |
| Alexandroupolis, 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 | |
| "Marika Iliadis" Hospital of Athens, 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, Dep of Medical Oncology | |
| Heraklion, Greece | |
| State General Hospital of Larissa, Dep of Medical Oncology | |
| Larissa,, Greece | |
| "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | |
| Piraeus, Greece | |
| "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | |
| Thessaloniki, Greece | |
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
| Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete, Dep of Medical Oncology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dimitris Mavrudis, Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00705315 History of Changes |
| Other Study ID Numbers: |
CT/07.21 |
| First Posted: | June 26, 2008 Key Record Dates |
| Last Update Posted: | August 19, 2010 |
| Last Verified: | August 2010 |
Keywords provided by Hellenic Oncology Research Group:
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breast cancer chemotherapy biological therapy |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bevacizumab Docetaxel Epirubicin Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents |
Growth Substances Physiological Effects of Drugs Growth Inhibitors Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |