Status:
TERMINATED
Trial of ZD1839 (Iressa) and Tamoxifen in Breast Cancer Patients
Lead Sponsor:
Baylor Breast Care Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The researchers want to learn whether ZD1839 can improve the activity of tamoxifen, a drug that participants will receive for the treatment of the type of breast cancer being studied. Tamoxifen medici...
Detailed Description
Epidermal growth factor receptor (EGFR) is expressed or over-expressed in many human solid tumors and plays an important role in progression to invasion and metastases. The EGFR tyrosine kinase is act...
Eligibility Criteria
Inclusion
- All patients must be female and must have signed an informed consent form.
- Primary breast cancers must be human epidermal growth factor receptor (HER2) overexpressing (2+ or 3+, or both, as determined by immunohistochemistry \[IHC\]), and estrogen receptor (ER) positive. Primary breast cancers must be of clinical and/or radiologic size \>4 cm, with or without gross metastatic disease according to the International Union against Cancer (UICC) modified World Health Organization (WHO) criteria.
- Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
- Adequate bone marrow function:
- Hematocrit \>30%,
- total neutrophil count must be \>1.5 x 10\^9/L, and
- platelet count \>100 x 10\^9/L.
- Renal function tests:
- creatinine within 1.5 times the institution's upper limit of normal (ULN).
- Liver function tests:
- Total serum bilirubin within ULN,
- liver transaminases within 2.5 x ULN,
- alkaline phosphatase within 5 x ULN.
- Performance status (WHO scale) \<2.
- Age \> 18 years.
Exclusion
- Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
- Women who are lactating or breastfeeding.
- Severe underlying chronic illness or disease.
- Patients on other investigational drugs while on study will be excluded.
- Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
- No previous or current malignancies at other sites within the preceding 5 years, with the exception of adequately treated, cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
- Any evidence of ongoing interstitial lung disease.
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00206492
Start Date
July 1 2003
End Date
October 1 2006
Last Update
August 1 2017
Active Locations (1)
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1
Baylor Breast Center
Houston, Texas, United States, 77030