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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00426530

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Feb 1, 2007

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RAD001 Daily Schedule 5mg or 10mg	Drug: everolimus (RAD001)
Experimental: RAD001 Weekly Schedule 30mg	Drug: everolimus (RAD001)

Arm

Intervention/Treatment

Experimental: RAD001 Daily Schedule

5mg or 10mg

Drug: everolimus (RAD001)

Experimental: RAD001 Weekly Schedule

30mg

Drug: everolimus (RAD001)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

To assess the ability to deliver the trastuzumab and vinorelbine therapy [After LPLV]
To assess everolimus, trastuzumab and vinorelbine blood levels in this combination [After LPLV]
To evaluate the overall tumor response [every 9 weeks/minus 1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Bruxelles		Belgium	1000
2	Novartis Investigative Site	Liege		Belgium	4000
3	Novartis Investigative Site	Paris		France	75231
4	Novartis Investigative Site	Milano	MI	Italy	20133
5	Novartis Investigative Site	Warszawa		Poland	02-781
6	Novartis Investigative Site	Stockholm		Sweden	SE-171 76