Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00426556 |
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.
Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: everolimus |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer |
Estimated Enrollment: | 52 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: everolimus
10 mg daily
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis U.S. | 862 778 8300 | |
Contact: Novartis Basel | 41 61 324 1111 |
United States, Arkansas | |
Highlands Oncology Group | Withdrawn |
Fayetteville, Arkansas, United States, 72703 | |
United States, California | |
UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Nathalie Chorn 310-825-4493 | |
Principal Investigator: Sarah Hurvitz, M.D. | |
Wilshire Oncology Medical Group | Not yet recruiting |
La Verne, California, United States, 91750 | |
Loma Linda University Medical center | Not yet recruiting |
Loma Linda, California, United States, 92354 | |
Compassionate Cancer CareMedical Group | Not yet recruiting |
Corona, California, United States, 92879 | |
Compassionate Cancer Care medical Group | Not yet recruiting |
Fountain Valley, California, United States, 92708 | |
United States, Florida | |
Florida Cancer care | Not yet recruiting |
Davie, Florida, United States, 33328 | |
United States, Georgia | |
Emory University | Not yet recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Tiffani Pierce 888-946-7447 | |
Principal Investigator: O'Regan, M.D. | |
United States, Illinois | |
Evanston Northwestern Healthcare | Recruiting |
Evanston, Illinois, United States, 60201 | |
United States, Missouri | |
Washington University School of Medicine - Siteman Cancer Center | Recruiting |
St. Louis, Missouri, United States, 63101 | |
Contact: Nicholas Fisher 314-454-5102 nfisher@im.wustl.edu | |
Principal Investigator: Naughton, M.D. | |
United States, South Carolina | |
Cancer Center of the Carolinas | Not yet recruiting |
Greenville, South Carolina, United States, 29615 | |
United States, Texas | |
Sammons Cancer Center | Withdrawn |
Dallas, Texas, United States, 78246 | |
Belgium | |
Novartis Investigative Site | Not yet recruiting |
Liege, Belgium | |
Novartis Investigative Site | Not yet recruiting |
Charleroi, Belgium | |
Novartis Investigative Site | Not yet recruiting |
Turnhout, Belgium | |
France | |
Novartis Investigative Site | Not yet recruiting |
Nantes, France | |
Novartis Investigative Site | Not yet recruiting |
Villejuif, France | |
Netherlands | |
Novartis Investigative Site | Not yet recruiting |
Maastricht, Netherlands | |
Spain | |
Novartis Investigative Site | Not yet recruiting |
Lerida, Spain | |
Novartis Investigative Site | Not yet recruiting |
Barcelona, Spain | |
Novartis Investigative Site | Not yet recruiting |
Valencia, Spain |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CRAD001J2101 |
Study First Received: | January 23, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00426556 |
Health Authority: | United States: Food and Drug Administration; Belgium: Directoraat Generaal Geneesmiddelen; France: Agence Française de Sécurité Sanitaire des Produits de Santé; Netherlands: Staatstoezicht op de volksgezondheid; Spain: Agencia española del medicamento |
Breast cancer Cancer of the breast Human mammary carcinoma HER-2 |
Metastatic everolimus trastuzumab paclitaxel |
Everolimus Skin Diseases Paclitaxel Trastuzumab |
Breast Neoplasms Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site Immunologic Factors |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |