NCT00146549

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Aug 2001

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

6 years

First QC Date

September 2, 2005

Last Update Submit

October 30, 2009

Conditions

Breast CancerStage IV Breast Cancer

Keywords

HER2-positive Breast cancerHER2 overexpressingtrastuzumabHerceptinvinorelbineNavelbineTaxoteretaxol

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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.

Interventions

TrastuzumabDRUG
VinorelbineDRUG
PaclitaxelDRUG
DocetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabVinorelbinePaclitaxelDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Harold Burstein, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

August 1, 2001

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

US(2)