Clinical trial · Interventional
Herceptin and GM-CSF for Metastatic Breast Cancer
Phase II Study of GM-CSF to Overcome Herceptin-Resistant HER-2/Neu-Overexpressing Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
| Herceptin | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HER2+ Metastatic Breast Cancer
- description
- Herceptin 4 mg/kg IV Over 90 Minutes + GM-CSF 250 mcg/m\^2 subcutaneously
- interventionNames
- Drug: Herceptin
- Drug: GM-CSF
Primary outcomes (1)
- measure
- Number of Participants With Tumor Response (Stable Disease)
- timeFrame
- 2 months
- description
- Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.
Secondary outcomes (1)
- measure
- Duration of Stable Disease
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available