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

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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
- Adequate liver function, as indicated by total bilirubin
- 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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.

Principal Investigator

Helena R Chang, M.D, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Revlon/UCLA Breast Center


United States: Institutional Review Board

Study ID:

IRB# 06-05-104



Start Date:

January 2007

Completion Date:

October 2007

Related Keywords:

  • Breast Cancer
  • non-metastatic breast cancer
  • HER-2 positive breast cancer
  • Herceptin (trastuzumab)
  • delayed adjuvant therapy
  • acceptability rate
  • non-metastatic, HER-2 positive breast cancer
  • Breast Neoplasms



Revlon/UCLA Breast Center Los Angeles, California  90095