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

NCT00193089 | Completed Phase 2 DMC

• 3 other identifiers: SCRI BRE 46GIA 11180H2369n
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.

  18 Months

Interventions

Docetaxel DRUG

Docetaxel

Vinorelbine DRUG

Vinorelbine

Trastuzumab DRUG

Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Aventis Pharmaceuticals: collaborator
• GlaxoSmithKline: collaborator

Related 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 Cancer. 2009 Feb;9(1):23-8. doi: 10.3816/CBC.2009.n.004.

  PMID: 19299236 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Vinorelbine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John D. Hainsworth, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2001
• Primary Completion: April 1, 2005
• Study Completion: September 1, 2009
• Last Updated: December 10, 2015

Record last verified: 2015-12