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

Breast Neoplasms Clinical Trial

Official title:

A Phase Ib Study Investigating the Combination of Everolimus With Trastuzumab and Vinorelbine in Patients With HER2-overexpressing Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426530
• Other study ID #: CRAD001J2102
• Secondary ID: 2006-001595-20
• Status: Completed
• Phase: Phase 1
• Start date: February 2007
• Est. completion date: June 2010

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• everolimus (RAD001)

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Liege
France	Novartis Investigative Site	Paris
Italy	Novartis Investigative Site	Milano	MI
Poland	Novartis Investigative Site	Warszawa
Sweden	Novartis Investigative Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)		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	To assess the ability to deliver the trastuzumab and vinorelbine therapy		After LPLV
Secondary	To assess everolimus, trastuzumab and vinorelbine blood levels in this combination		After LPLV
Secondary	To evaluate the overall tumor response		every 9 weeks/minus 1 week

External Links

•   Results for CRAD001J2102 can be found on the Novartis Clinical Trial Results Website