NCT00429104

Brief Summary

Primary Objectives:

  1. 1.To determine the patient's tumor response rate that this protocol will produce.
  2. 2.To determine the 1 year progression-free survival that this protocol will produce.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

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, 2002

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 15, 2011

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

7.3 years

First QC Date

January 29, 2007

Results QC Date

March 25, 2011

Last Update Submit

December 4, 2012

Conditions

Breast Cancer

Keywords

Breast CancerCarcinoma of the BreastHER-2/neu OverexpressionHerceptinTrastuzumabGM-CSFSargramostimLeukine

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Tumor Response (Stable Disease)

    Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.

    2 months

Secondary Outcomes (1)

  • Duration of Stable Disease

    6 Years

Study Arms (1)

HER2+ Metastatic Breast Cancer

EXPERIMENTAL

Herceptin 4 mg/kg IV Over 90 Minutes + GM-CSF 250 mcg/m\^2 subcutaneously

Drug: HerceptinDrug: GM-CSF

Interventions

HerceptinDRUG

4 mg/kg IV Over 90 Minutes

Also known as: Trastuzumab
HER2+ Metastatic Breast Cancer
GM-CSFDRUG

250 mcg/m\^2 Subcutaneously

Also known as: Sargramostim, Leukine
HER2+ Metastatic Breast Cancer

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histological confirmation of invasive carcinoma of the breast.
  • HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).
  • Stage IV breast cancer with measurable disease.
  • Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.
  • Zubrod performance status 0 or 1.
  • Adequate hematological parameters (White Blood cells-WBC \> 3,000/mm3, platelet count \> 100,000/mm3), adequate renal function (serum creatinine \< 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) \< 3 x normal).

You may not qualify if:

  • Active Brain metastasis.
  • No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).
  • More than 2 Herceptin containing regimens in metastatic breast cancer.
  • Known history of HIV positive.
  • Chronic active hepatitis or cirrhosis.
  • Symptomatic pulmonary disease.
  • Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabGranulocyte-Macrophage Colony-Stimulating Factorsargramostim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Results Point of Contact

Title
Naoto Ueno, MD.PhD./Professor
Organization
University of Texas MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org
713-792-8754

Study Officials

  • Naoto Ueno, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

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

January 29, 2007

First Posted

January 31, 2007

Study Start

August 1, 2002

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 6, 2012

Results First Posted

April 15, 2011

Record last verified: 2012-12

Locations

US(1)