Status:
WITHDRAWN
INST 0514C- Biologic Correlative Study: Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients
Lead Sponsor:
University of New Mexico
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE1
PHASE2
Brief Summary
Neoadjuvant chemotherapy has become the standard of care for breast cancer patients with large tumors in order to render them operable for mastectomy or, in some cases, for lumpectomy and radiation th...
Detailed Description
See above.
Eligibility Criteria
Inclusion
- All patients must be female.
- Signed informed consent.
- 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.
- 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.
- Negative serum pregnancy test (beta-HCG) within 7 days of starting study, if of child-bearing potential.
- Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.
- Performance status (WHO scale) \<2 and life expectancy \>6 months.
- Age \>18 years.
- No brain or leptomeningeal disease.
- 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.
Exclusion
- Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
- Severe underlying chronic illness or disease.
- Cardiomyopathy or baseline LVEF \<50%.
- Other investigational drugs while on study.
- Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00455039
Start Date
July 31 2023
End Date
July 31 2023
Last Update
August 14 2023
Active Locations (1)
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1
UNM CRTC
Albuquerque, New Mexico, United States, 87106