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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193089
• Other study ID #: SCRI BRE 46
• Secondary ID: GIA 11180H2369n
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 9, 2015
• Start date: April 2001
• Est. completion date: September 2009

Study information

• Verified date: December 2015
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel
• Vinorelbine
Vinorelbine
• Trastuzumab
Trastuzumab

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, GlaxoSmithKline

References & Publications (1)

Infante JR, Yardley DA, Burris HA 3rd, Greco FA, Farley CP, Webb C, Spigel DR, Hainsworth JD. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.		18 Months	No