NCT00426530

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2007

Typical duration for phase_1

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 21, 2020

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

January 23, 2007

Last Update Submit

December 17, 2020

Conditions

Breast NeoplasmsNeoplasm Metastasis

Keywords

HER2-overexpressing metastatic breast cancerBreast cancerCancer of the breastHuman mammary carcinomaHER-2metastaticeverolimustrastuzumabvinorelbine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

RAD001 Daily Schedule

EXPERIMENTAL

5mg or 10mg

Drug: everolimus (RAD001)

RAD001 Weekly Schedule

EXPERIMENTAL

30mg

Drug: everolimus (RAD001)

Interventions

everolimus (RAD001)DRUG
RAD001 Daily ScheduleRAD001 Weekly Schedule

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

Brussels, 1000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Paris, 75231, France

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Warsaw, 02-781, Poland

Location

Novartis Investigative Site

Stockholm, SE-171 76, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21107682DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 21, 2020

Record last verified: 2016-04

Locations

BE(2)SE(1)FR(1)PL(1)IT(1)