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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)

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

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

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

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

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

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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