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Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00426530
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Neoplasm Metastasis Drug: everolimus (RAD001) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study Investigating the Combination of Everolimus With Trastuzumab and Vinorelbine in Patients With HER2-overexpressing Metastatic Breast Cancer
Study Start Date : February 2007
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: RAD001 Daily Schedule
5mg or 10mg
Drug: everolimus (RAD001)
Experimental: RAD001 Weekly Schedule
Drug: everolimus (RAD001)

Primary Outcome Measures :
  1. To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT) [ Time Frame: after ever DLT within the first cycle, at least 21 days on treatment, every 2 months from first date of enrollment in a particular regimen ]

Secondary Outcome Measures :
  1. To assess the ability to deliver the trastuzumab and vinorelbine therapy [ Time Frame: After LPLV ]
  2. To assess everolimus, trastuzumab and vinorelbine blood levels in this combination [ Time Frame: After LPLV ]
  3. To evaluate the overall tumor response [ Time Frame: every 9 weeks/minus 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Female or male patients ≥18 years with WHO performance status ≤ 1
  • HER-2 overexpressing 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
  • 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 vinorelbine or mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

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): NCT00426530

Novartis Investigative Site
Bruxelles, Belgium, 1000
Novartis Investigative Site
Liege, Belgium, 4000
Novartis Investigative Site
Paris, France, 75231
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Warszawa, Poland, 02-781
Novartis Investigative Site
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00426530     History of Changes
Other Study ID Numbers: CRAD001J2102
2006-001595-20 ( EudraCT Number )
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HER2-overexpressing metastatic breast cancer
Breast cancer
Cancer of the breast
Human mammary carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents, Phytogenic