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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427427
Recruitment Status : Terminated (lack of accrual)
First Posted : January 29, 2007
Last Update Posted : August 1, 2016
Information provided by:
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer
Study Start Date : January 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427427

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United States, California
Revlon/UCLA Breast Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
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Principal Investigator: Helena R Chang, M.D, Ph.D. Revlon/UCLA Breast Center

Layout table for additonal information Identifier: NCT00427427     History of Changes
Other Study ID Numbers: IRB# 06-05-104
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: October 2007

Keywords provided by Jonsson Comprehensive Cancer Center:
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents