NCT00148668

Brief Summary

The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

4 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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 25, 2013

Completed
Last Updated

April 9, 2013

Status Verified

March 1, 2013

Enrollment Period

5.1 years

First QC Date

September 7, 2005

Results QC Date

December 19, 2012

Last Update Submit

March 29, 2013

Conditions

Breast Cancer

Keywords

HER-2 Positive Breast CancerherceptinnavelbinetaxoterecarboplatinEarly stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer

    Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery

    12 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Herceptin/navelbine

Drug: HerceptinDrug: Navelbine

Arm 2

ACTIVE COMPARATOR

Taxotere/carboplatin/herceptin

Drug: HerceptinDrug: TaxotereDrug: Carboplatin

Interventions

HerceptinDRUG

One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.

Also known as: Trastuzumab
Arm 1Arm 2
NavelbineDRUG

Weekly injections given starting week 3 and ending week 14

Also known as: vinorelbine
Arm 1
TaxotereDRUG

Given every three weeks starting week 3 and ending on week 14

Also known as: docetaxel
Arm 2
CarboplatinDRUG

Given every three weeks starting week 3 and ending on week 14

Also known as: paraplatin
Arm 2

Eligibility Criteria

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

You may qualify if:

  • Patients with stage II or III breast cancer
  • HER-2 positive tumors
  • Older than 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
  • ANC \> 1,500/mm3
  • Hemoglobin \> 9gm/dl
  • Platelets \> 100,000mm3
  • Creatinine \< 2mg/dl
  • Glucose \< 200mg/dl
  • Bilirubin \< 1.5 x ULN

You may not qualify if:

  • Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
  • Pregnant or breast-feeding women
  • Serious illness, or medical or psychiatric condition
  • Uncontrolled infections
  • Active or severe cardiovascular or pulmonary disease
  • Patients with left ventricular ejection fraction \< 50%
  • Peripheral neuropathy of any etiology that exceeds grade 1
  • Prior history of malignancy
  • Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabVinorelbineDocetaxelCarboplatin

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 ChemicalsDiterpenesTerpenesCoordination Complexes

Results Point of Contact

Title
Dr Eric Winer
Organization
Dana-Farber Cancer Institute
eric_winer@dfci.harvard.edu
617-632-2335

Study Officials

  • Eric Winer, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Division of Women's Cancers

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

December 1, 2003

Primary Completion

January 1, 2009

Study Completion

August 1, 2011

Last Updated

April 9, 2013

Results First Posted

January 25, 2013

Record last verified: 2013-03

Locations

US(4)