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Sponsors and Collaborators: |
Hellenic Oncology Research Group University Hospital of Crete |
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Information provided by: | Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00691379 |
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
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Carboplatin Drug: Bevacizumab Drug: Paclitaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 46 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Paclitaxel/Carboplatin/Bevacizumab
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Drug: Carboplatin
Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
Drug: Bevacizumab
Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
Drug: Paclitaxel
Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
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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
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Eva Maragkoudaki | +302810392857 | dorachat@med.uoc.gr |
Greece | |
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106442666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302810392857 secretary@horg.gr | |
Principal Investigator: Nikos Malamos, MD | |
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302810392857 secretary@horg.gr | |
Principal Investigator: Aris Polyzos, MD | |
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302810392857 secretary@horg.gr | |
Principal Investigator: Nikos Ziras, MD | |
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Giassas, MD | |
401 Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Charalampos Christophillakis, MD | |
University Hospital of Crete | Recruiting |
Heraklion, Greece | |
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr | |
Sub-Investigator: Manolis Saloustros, MD | |
State General Hospital of Larissa, Dep of Medical Oncology | Recruiting |
Larissa, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Athanasios Athanasiadis, MD | |
University General Hospital of Alexandroupolis | Recruiting |
Alexandroupolis, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Kakolyris, MD | |
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Recruiting |
Thessaloniki, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Ioannis Boukovinas, MD | |
"Diabalkaniko" hospital, Thessaloniki | Recruiting |
Thessaloniki, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Christos Emmanouilidis, MD | |
Air Forces Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +30281392857 secretary@horg.gr | |
Principal Investigator: Nikos Kentepozidis, MD |
Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete |
Responsible Party: | University Hospital of Crete ( D.Mavrudis ) |
Study ID Numbers: | CT/08.02 |
Study First Received: | May 29, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00691379 |
Health Authority: | Greece: National Organization of Medicines |
Breast cancer Triple negative Chemotherapy Anti-angiogenesis therapy |
Skin Diseases Paclitaxel Breast Neoplasms |
Carboplatin Bevacizumab Breast Diseases |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |