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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00426530
First received: January 23, 2007
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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: 60
Study Start Date: February 2007
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
30mg
Drug: everolimus (RAD001)

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426530

Locations
Belgium
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Liege, Belgium
France
Novartis Investigative Site
Paris, France
Italy
Novartis Investigative Site
Milan, Italy
Poland
Novartis Investigative Site
Warsaw, Poland
Sweden
Novartis Investigative Site
Stockholm, Sweden
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00426530     History of Changes
Other Study ID Numbers: CRAD001J2102
Study First Received: January 23, 2007
Last Updated: October 6, 2011
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
HER-2
metastatic
everolimus
trastuzumab
vinorelbine

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

ClinicalTrials.gov processed this record on July 31, 2014