Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer
Completed · Phase 2
Conditions studied: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
In brief
Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill breast cancer cells. Phase II trial to study the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic breast cancer that has not responded to previous trastuzumab therapy.
Key facts
- Study ID
- NCT00006228
- Run by
- National Cancer Institute (NCI)
- People needed
- 37
- Starts
- 2000-07-01
- Last updated by the study team
- 2013-10-08
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed breast cancer
- Primary and/or metastatic disease
- HER2 overexpression 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
- Tumors with HER2 2+ overexpression by IHC allowed if confirmed by FISH
- Progressive disease during or within 12 months of receiving prior regimen containing trastuzumab (Herceptin)
- Unidimensionally measurable disease
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- The following are not considered measurable:
- Bone metastases
- Pleural or peritoneal effusion
- Ascites
- Leptomeningeal disease
- Lymphangitic disease
- Inflammatory breast cancer
- Cystic lesions
- CNS lesions
- CNS metastases allowed if all of the following conditions are met:
- Asymptomatic
- At least 3 months since prior surgery and/or cranial irradiation
- At least 3 weeks since prior steroids
- Hormone receptor status:
- Not specified
- Male or female
- Performance status - ECOG 0-2
- Granulocyte count at least 1,000/mm\^3
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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