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

This study has been terminated.
(lack of accrual)
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00427427
First received: January 25, 2007
Last updated: October 25, 2007
Last verified: October 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Trastuzumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
  • To evaluate signs and symptoms of cardiotoxicity.

Secondary Outcome Measures:
  • Annual assessment of recurrent disease.
  • Overall survival and disease specific survival.

Estimated Enrollment: 75
Study Start Date: January 2007
Study Completion Date: October 2007
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427427

Locations
United States, California
Revlon/UCLA Breast Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Helena R Chang, M.D, Ph.D. Revlon/UCLA Breast Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00427427     History of Changes
Other Study ID Numbers: IRB# 06-05-104, H3754s
Study First Received: January 25, 2007
Last Updated: October 25, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
non-metastatic breast cancer
HER-2 positive breast cancer
Herceptin (trastuzumab)
 delayed adjuvant therapy
acceptability rate
non-metastatic, HER-2 positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
 Trastuzumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013