Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms, Neoplasm Metastasis

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)

Outcome 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

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001J2102

NCT ID:

NCT00426530

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • HER2-overexpressing metastatic breast cancer
  • Breast cancer
  • Cancer of the breast
  • Human mammary carcinoma
  • HER-2
  • metastatic
  • everolimus
  • trastuzumab
  • vinorelbine
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location