Herceptin and GM-CSF for Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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 Objective: 1\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF).

Key facts

Study ID

NCT00429104

Run by

M.D. Anderson Cancer Center

People needed

18

Starts

2002-08-01

Expected to finish

2009-11-01

Last updated by the study team

2012-12-06

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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