Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
Primary Purpose
Breast Neoplasms, Neoplasm Metastasis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
everolimus (RAD001)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring HER2-overexpressing metastatic breast cancer, Breast cancer, Cancer of the breast, Human mammary carcinoma, HER-2, metastatic, everolimus, trastuzumab, vinorelbine
Eligibility 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RAD001 Daily Schedule
RAD001 Weekly Schedule
Arm Description
5mg or 10mg
30mg
Outcomes
Primary Outcome Measures
To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)
Secondary Outcome Measures
To assess the ability to deliver the trastuzumab and vinorelbine therapy
To assess everolimus, trastuzumab and vinorelbine blood levels in this combination
To evaluate the overall tumor response
Full Information
NCT ID
NCT00426530
First Posted
January 23, 2007
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00426530
Brief Title
Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
Official Title
A Phase Ib Study Investigating the Combination of Everolimus With Trastuzumab and Vinorelbine in Patients With HER2-overexpressing Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Neoplasm Metastasis
Keywords
HER2-overexpressing metastatic breast cancer, Breast cancer, Cancer of the breast, Human mammary carcinoma, HER-2, metastatic, everolimus, trastuzumab, vinorelbine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RAD001 Daily Schedule
Arm Type
Experimental
Arm Description
5mg or 10mg
Arm Title
RAD001 Weekly Schedule
Arm Type
Experimental
Arm Description
30mg
Intervention Type
Drug
Intervention Name(s)
everolimus (RAD001)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess the ability to deliver the trastuzumab and vinorelbine therapy
Time Frame
After LPLV
Title
To assess everolimus, trastuzumab and vinorelbine blood levels in this combination
Time Frame
After LPLV
Title
To evaluate the overall tumor response
Time Frame
every 9 weeks/minus 1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21107682
Citation
Jerusalem G, Fasolo A, Dieras V, Cardoso F, Bergh J, Vittori L, Zhang Y, Massacesi C, Sahmoud T, Gianni L. Phase I trial of oral mTOR inhibitor everolimus in combination with trastuzumab and vinorelbine in pre-treated patients with HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2011 Jan;125(2):447-55. doi: 10.1007/s10549-010-1260-x. Epub 2010 Nov 25.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5725
Description
Results for CRAD001J2102 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
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