Status:
COMPLETED
Herceptin and GM-CSF for Metastatic Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bayer
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Primary Objectives: 1. To determine the patient's tumor response rate that this protocol will produce. 2. To determine the 1 year progression-free survival that this protocol will produce. Secondary...
Detailed Description
GM-CSF stimulates the immune system and may increase the effectiveness of Herceptin. Before you can start treatment on this study, you will have what are called "screening tests." These tests will he...
Eligibility Criteria
Inclusion
- Histological confirmation of invasive carcinoma of the breast.
- HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).
- Stage IV breast cancer with measurable disease.
- Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.
- Zubrod performance status 0 or 1.
- Adequate hematological parameters (White Blood cells-WBC \> 3,000/mm3, platelet count \> 100,000/mm3), adequate renal function (serum creatinine \< 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) \< 3 x normal).
Exclusion
- Active Brain metastasis.
- No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).
- More than 2 Herceptin containing regimens in metastatic breast cancer.
- Known history of HIV positive.
- Chronic active hepatitis or cirrhosis.
- Symptomatic pulmonary disease.
- Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00429104
Start Date
August 1 2002
End Date
November 1 2009
Last Update
December 6 2012
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030