NCT00136539

Brief Summary

The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_2 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

March 1, 1999

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

7.7 years

First QC Date

August 26, 2005

Last Update Submit

February 15, 2013

Conditions

Breast Cancer

Keywords

Breast CancerEarly Stage Breast CancerHER2-positiveHER2-positive breast cancerHerceptinTaxolStage II Breast CancerStage III Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery

Secondary Outcomes (1)

  • To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy

    3 years

Interventions

HerceptinDRUG

Given intravenously once weekly for 12 weeks prior to surgery.

TaxolDRUG

Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.

AdriamycinDRUG

Given every three weeks for 12 weeks after surgery.

CytoxanDRUG

Given every three weeks for 12 weeks after surgery.

Eligibility Criteria

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

You may qualify if:

  • Patients must have Stage II or III histologically diagnosed breast cancer
  • Primary invasive breast cancers that overexpress the HER2/neu oncogene
  • Age older than 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of \< 1
  • White blood cell (WBC) \> 4000/mm3
  • Platelet count \> 100,000/mm3
  • Bilirubin \< 1 x upper limit of normal (ULN)
  • SGOT \< 1 x ULN
  • Creatinine \< 1.5mg/dl
  • Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy

You may not qualify if:

  • Excisional biopsy, sentinel node dissection or axillary node dissection.
  • Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
  • Pregnant or breast-feeding women
  • Uncontrolled infection
  • Active or severe cardiovascular or pulmonary disease
  • Peripheral neuropathy of any etiology that exceeds grade 1
  • Prior history of malignancy treated without curative intent
  • Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

TrastuzumabPaclitaxelDoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Harold Burstein, MD, PhD

    Dana-Farber Cancer Institute

    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 INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

March 1, 1999

Primary Completion

November 1, 2006

Study Completion

March 1, 2012

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(2)