Status:
COMPLETED
Neoadjuvant GW572016 to Treat Breast Cancer
Lead Sponsor:
Baylor Breast Care Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
We want to learn whether GW572016 is effective in breast cancers that have HER2.
Detailed Description
The EGFR/HER family of transmembrane type I receptor tyrosine kinases are enzymes that play an important role in fundamental cell processes like cell proliferation, differentiation, and survival. Thes...
Eligibility Criteria
Inclusion
- All patients must be female.
- Signed informed consent.
- Locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size \>/- 5 cm, and/or are deemed surgically inoperable, with Stage IIIb, IIIc, or IV 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 (BHCG) 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) less than 2 and life expectancy greater than 6 months.
- Age greater than 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 core-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.
- Taking any GW572016-prohibited medication (see GW572016 Prohibited Medications List in protocol) within 7 days of first dose of study medications.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00206427
Start Date
August 1 2004
End Date
February 1 2012
Last Update
September 29 2021
Active Locations (3)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
University of New Mexico
Albuquerque, New Mexico, United States, 87131
3
Baylor Breast Center
Houston, Texas, United States, 77030