Herceptin and GM-CSF for Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Bayer
• Treatments: Sargramostim; Trastuzumab

Criteria

Inclusion Criteria:

1. Histological confirmation of invasive carcinoma of the breast.

2. HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).

3. Stage IV breast cancer with measurable disease.

4. Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.

5. Zubrod performance status 0 or 1.

6. 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 Criteria:

1. Active Brain metastasis.

2. No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).

3. More than 2 Herceptin containing regimens in metastatic breast cancer.

4. Known history of HIV positive.

5. Chronic active hepatitis or cirrhosis.

6. Symptomatic pulmonary disease.

7. Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.