Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer

July 28, 2016 updated by: Jonsson Comprehensive Cancer Center

A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study Phase- Phase II Study Type- Interventional Study Design-

This is an open label, non-randomized phase II study in patients with non-metastatic HER-2 positive breast cancer by FISH diagnosed in 2004 or thereafter. Potential patients will sign a written ICF prior to completing a questionnaire designed to determine what factors may affect a patient's acceptance of Herceptin® treatment. After answering the questionnaire, patients will be given the following options:

  1. to receive one year of trastuzumab treatment and annual follow-up for 5 years
  2. to decline trastuzumab treatment but serve as a comparison group member for monitoring safety and effectiveness of trastuzumab and to have annual follow-up for 5 years

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Revlon/UCLA Breast Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Confirmed non-metastatic infiltrating carcinoma of the breast.
  2. HER-2 amplified (FISH +) determination in 2004 or thereafter.
  3. ECOG performance status 0-2.
  4. Patients 18 years of age or older.
  5. HER-2 status is determined by FISH test.

  6. 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.
  7. Signed informed consent has been obtained.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
To evaluate signs and symptoms of cardiotoxicity.

Secondary Outcome Measures

Outcome Measure
Annual assessment of recurrent disease.
Overall survival and disease specific survival.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Helena R Chang, M.D, Ph.D., Revlon/UCLA Breast Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 06-05-104
  • H3754s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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