Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer

October 30, 2009 updated by: Dana-Farber Cancer Institute

A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer

The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • All patients will receive trastuzumab then be randomized into one of two arms. Arm A: Trastuzumab in combination with weekly vinorelbine and Arm B: Trastuzumab in combination with a weekly taxane-based regimen, either paclitaxel or docetaxel, chosen at the discretion of the investigator.
  • Treatment is administered on an outpatient basis. Trastuzumab is administered weekly. There is a one-time loading dose for the first week of the first cycle. For that initial treatment, only, the trastuzumab dose is 4mg/kg. The dose for all subsequent weekly trastuzumab treatments is 2mg/kg.
  • Arm A: vinorelbine is administered every week and the dose is adjusted based on the absolute neutrophil count for that week. Vinorelbine is given after trastuzumab.
  • Arm B: Either paclitaxel given weekly (dose bases on absolute neutrophil count) or docetaxel given on weeks 1,2,3,5,6,7 of each 8-week cycle (dose based upon absolute neutrophil count). Patients on paclitaxel will also receive dexamethasone, diphenhydramine and ranitidine to help prevent allergic or hypersensitivity reactions. Patients on docetaxel will receive dexamethasone to help reduce fluid retention or edema.
  • Every 8 weeks the patients cancer will be re-evaluated to see if the treatment is working. If the treatment appears to be working, treatment will continue. Standard radiological testing (x-rays, CT scan, radioactive drug scans, or MRI's) will be used to follow the disease treatment.
  • Heart function will be measured after 16 weeks to be sure it is safe to continue treatment.
  • Every 8 weeks, patients' will be asked to complete a brief written survey that asks about symptoms and side effects.
  • Patients' will remain on the treatment as long as there is no disease progression or unacceptable side effects.

Study Type

Interventional

Enrollment

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast cancer, with stage IV disease
  • Tumors must be HER2 overexpressing
  • Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
  • 18 years of age or older
  • Life expectancy of greater than 6 months
  • ECOG performance status of 0-2
  • ANC count > 1,500/mm3
  • Platelets > 100,000/mm3
  • Total bilirubin < 1.5 mg/dl
  • AST/ALT < 115 U/I
  • Creatinine < 2.0 mg/dl
  • Glucose < 200 mg/dl
  • LVEF > 50%

Exclusion Criteria:

  • Prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer
  • Concurrent hormonal therapy, chemotherapy, or radiation treatments
  • Pregnant or lactating women
  • Known brain metastases or leptomeningeal carcinomatosis
  • History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to the agents in this study
  • Pre-existing neuropathy from any cause in excess of grade 1
  • Uncontrolled intercurrent illness
  • History of other non-breast cancer malignancy except for carcinoma in situ of the cervix or non-melanoma skin cancer
  • Patients taking macrolide antibiotics, ketoconazole, or AZT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.

Secondary Outcome Measures

Outcome Measure
Characterization of the time to disease progression and time to treatment failure for patients receiving trastuzumab with either vinorelbine or taxane-based chemotherapy
Characterization of side effects for both treatments
analysis of quality of life for patients receiving either treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
GlaxoSmithKline
Brigham and Women's Hospital
North Shore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

November 1, 2009

Last Update Submitted That Met QC Criteria

October 30, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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