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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 23, 2007
Last updated: April 20, 2016
Last verified: April 2016
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 Intervention Phase
Breast Neoplasms
Neoplasm Metastasis
Drug: everolimus (RAD001)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the ability to deliver the trastuzumab and vinorelbine therapy [ Time Frame: After LPLV ] [ Designated as safety issue: No ]
  • To assess everolimus, trastuzumab and vinorelbine blood levels in this combination [ Time Frame: After LPLV ] [ Designated as safety issue: No ]
  • To evaluate the overall tumor response [ Time Frame: every 9 weeks/minus 1 week ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Daily Schedule
5mg or 10mg
Drug: everolimus (RAD001)
Experimental: RAD001 Weekly Schedule
Drug: everolimus (RAD001)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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

  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00426530     History of Changes
Other Study ID Numbers: CRAD001J2102  2006-001595-20 
Study First Received: January 23, 2007
Last Updated: April 20, 2016
Health Authority: United States: Food and Drug Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Poland: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by Novartis:
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 processed this record on October 21, 2016