PS-341 in Treating Women With Metastatic Breast Cancer
Completed · Phase 2
Conditions studied: Recurrent Breast Cancer, Stage IV Breast Cancer
In brief
PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer
Key facts
- Study ID
- NCT00025584
- Run by
- National Cancer Institute (NCI)
- People needed
- 35
- Starts
- 2001-08-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed invasive breast cancer
- Clinical and/or radiological evidence of stage IV disease
- Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- No bone metastases as only measurable site
- Pleural or peritoneal effusions not acceptable as measurable disease
- No known brain metastases
- Hormone receptor status:
- Estrogen receptor-negative
- Estrogen receptor-positive
- Female
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin normal
- AST or ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No acute ischemia or significant conduction abnormality by EKG
- No symptomatic congestive heart failure
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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