Phase 2
N=18
Herceptin and GM-CSF for Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00429104 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Tumor Response (Stable Disease) — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Herceptin (Drug); GM-CSF (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Tumor Response (Stable Disease) |
5 | — |
| SECONDARY Duration of Stable Disease |
15.8 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00429104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.