Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of New Mexico
See above.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. All patients must be female.
2. Signed informed consent.
3. Only subjects with Stage IIIa, IIIb, IIIc, or IV disease should be enrolled in this trial. Locally advanced breast cancers of clinical and or radiologic size greater than or equal to 3 cm, or primary breast cancers with concomitant gross metastatic disease.
4. HER2 overexpressing tumors defined as HercepTest score of 3+, or \> 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of \>5 (in Dr. Allred's laboratory) or gene amplified.
5. Negative serum pregnancy test (beta-HCG) within 7 days of starting study, if of child-bearing potential.
6. Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.
7. Performance status (WHO scale) \<2 and life expectancy \>6 months.
8. Age \>18 years.
9. No brain or leptomeningeal disease.
10. No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
You may not be if
1. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
2. Severe underlying chronic illness or disease.
3. Cardiomyopathy or baseline LVEF \<50%.
4. Other investigational drugs while on study.
5. Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
6. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
Clareo Health | INST 0514C- Biologic Correlative Study: Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients
