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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426530

Enrollment

Registered

2007-01-24

Start date

2007-02-28

Completion date

2010-06-30

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGeverolimus (RAD001)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Belgium, France, Italy, Poland, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026