Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-Overexpressing Metastatic Breast Cancer - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00426556

Purpose

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Everolimus Trastuzumab

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Phase l: To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity rate. [ Time Frame: at every critical DLT, after 6 patients have completed cycle 1 or every 2 months ] [ Designated as safety issue: Yes ]
Phase II: To evaluate the efficacy of the dose/level regimen of RAD001 recommended from the phase I with trastuzumab and paclitaxel therapy. This will be based on the overall response rate. [ Time Frame: every 8 - 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phase I : Assess ability to deliver trastuzumab and paclitaxel therapy based on the relative dose intensity of paclitaxel & on the discontinuation rate of trastuzumab, assess everolimus, trastuzumab & paclitaxel PK in a subset of patients [ Time Frame: every 8 - 9 weeks ] [ Designated as safety issue: No ]
To evaluate progression free survival, time to progression, overall survival and to describe the safety profile of the phase II part combination. [ Time Frame: every 8 - 9 weeks ] [ Designated as safety issue: Yes ]

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female or male patients ≥ 18 years old with WHO performance status ≤ 1
HER-2 over-expressing metastatic breast cancer cells confirmed by histology
Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l)
Patient resistance to trastuzumab and taxanes (Phase ll)
Measurable disease according to RECIST (Phase ll)
Patients neurologically stable with adequate bone marrow, liver and renal function

Exclusion Criteria:

Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
Patients who have previously received mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426556

Contacts

Contact: Novartis U.S.	862 778 8300
Contact: Novartis Basel	41 61 324 1111

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Breast Cancer This link exits the ClinicalTrials.gov site

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

Keywords provided by Novartis:

Breast cancer
Cancer of the breast
Human mammary carcinoma
HER-2

Metastatic
everolimus
trastuzumab
paclitaxel

Study placed in the following topic categories:

Everolimus
Skin Diseases
Paclitaxel
Trastuzumab

Breast Neoplasms
Breast Diseases
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009