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

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00427427

Run by

Jonsson Comprehensive Cancer Center

People needed

75

Starts

2007-01-01

Expected to finish

2007-10-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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