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

Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193089

Enrollment

Registered

2005-09-19

Start date

2001-04-30

Completion date

2009-09-30

Last updated

2015-12-10

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

Conditions

Breast Cancer

Brief summary

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

Detailed description

Upon determination of eligibility, all patients will be receive: Trastuzumab + Vinorelbine + Docetaxel

Interventions

DRUGDocetaxel

Docetaxel

DRUGVinorelbine

Vinorelbine

DRUGTrastuzumab

Trastuzumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.	18 Months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026