Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Vinorelbine

Drug: Trastuzumab

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193089

SCRI BRE 46

H2369n

GIA 11180

Details and patient eligibility

About

In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

Full description

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria:

Metastatic breast cancer confirmed by biopsy
Overexpression of the Her-2 oncogene
Age > 18 years
Measurable disease
Able to perform activities of daily living with minimal assistance
No previous chemotherapy for metastatic disease
One or more previous hormonal therapies for metastatic disease.
Adequate bone marrow, liver and kidney function
Patients with < grade 1 peripheral neuropathy are eligible.
Must give written informed consent prior to entering this study.

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

Abnormal heart function
Previous treatment with trastuzumab
Brain metastases untreated
Pre-existing symptomatic peripheral neuropathy
Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.