Back to resultsDelayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring non-metastatic breast cancer, HER-2 positive breast cancer, Herceptin (trastuzumab), delayed adjuvant therapy, acceptability rate, non-metastatic, HER-2 positive breast cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Revlon/UCLA Breast Center
Outcomes
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.
Full Information
NCT ID
NCT00427427
First Posted
January 25, 2007
Last Updated
July 28, 2016
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00427427
Brief Title
Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
Official Title
A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
lack of accrual
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
5. Study Description
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.
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:
to receive one year of trastuzumab treatment and annual follow-up for 5 years
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
non-metastatic breast cancer, HER-2 positive breast cancer, Herceptin (trastuzumab), delayed adjuvant therapy, acceptability rate, non-metastatic, HER-2 positive breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Primary Outcome Measure Information:
Title
To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
Title
To evaluate signs and symptoms of cardiotoxicity.
Secondary Outcome Measure Information:
Title
Annual assessment of recurrent disease.
Title
Overall survival and disease specific survival.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena R Chang, M.D, Ph.D.
Organizational Affiliation
Revlon/UCLA Breast Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Revlon/UCLA Breast Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
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