NCT00427427

Brief Summary

The purpose of the study is to determine what factors affect a patient's decision to accept delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or radiation therapy. Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004 or thereafter and who have completed surgery and primary treatment earlier will be potentially eligible. Patients will be asked to complete a questionnaire about their breast cancer and reasons why they may or may not accept Herceptin® treatment. Patients will be given the option to (1) receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to receive Herceptin® but agree to annual doctor visits for 5 years.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

August 1, 2016

Status Verified

October 1, 2007

First QC Date

January 25, 2007

Last Update Submit

July 28, 2016

Conditions

Breast Cancer

Keywords

non-metastatic breast cancerHER-2 positive breast cancerHerceptin (trastuzumab)delayed adjuvant therapyacceptability ratenon-metastatic, HER-2 positive breast cancer

Outcome Measures

Primary Outcomes (2)

  • To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.

  • To evaluate signs and symptoms of cardiotoxicity.

Secondary Outcomes (2)

  • Annual assessment of recurrent disease.

  • Overall survival and disease specific survival.

Interventions

TrastuzumabDRUG

Eligibility Criteria

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

You may qualify if:

  • Confirmed non-metastatic infiltrating carcinoma of the breast.
  • HER-2 amplified (FISH +) determination in 2004 or thereafter.
  • ECOG performance status 0-2.
  • Patients 18 years of age or older.
  • HER-2 status is determined by FISH test.
  • The following criteria are applicable to the trastuzumab treatment group:
  • Normal LVEF as determined by ECHO or MUGA. If baseline LVEF \> 75%, then LVEF shall be repeated to determine if falsely elevated.
  • Adequate bone marrow function as indicated by the following: ANC \>1500/mL, Platelets \>/=100,000/mL, Hemoglobin \>9 g/dL
  • Adequate renal function,as indicated by serum creatinine \</= 1.5 x ULN
  • Adequate liver function, as indicated by total bilirubin \</= 1.5 x ULN
  • AST and ALT \< 2 x ULN unless related to primary disease.
  • If female of childbearing potential, pregnancy test (blood or urine) is negative and she agrees to use effective birth control method for the duration of the study.
  • Signed informed consent has been obtained.

You may not qualify if:

  • Non-confirmed HER-2 positive by FISH infiltrating carcinoma of the breast.
  • Evidence of metastatic disease.
  • Previous trastuzumab treatment.
  • Concurrent anticancer treatment other than hormonal agents (tamoxifen, aromatase inhibitors) or radiotherapy.
  • Patient with history of or active cardiac disease, including cardiomyopathy, congestive heart failure, prior myocardial infarction, or arrhythmia.
  • Symptomatic intrinsic lung disease resulting in dyspnea at rest.
  • Concurrent life-limiting disease with a life expectancy of less than one year.
  • Pregnancy, nursing women, and fertile women who do not practice birth control.
  • Inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Revlon/UCLA Breast Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Helena R Chang, M.D, Ph.D.

    Revlon/UCLA Breast Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

January 1, 2007

Study Completion

October 1, 2007

Last Updated

August 1, 2016

Record last verified: 2007-10

Locations

US(1)