None listed
Conditions
Interventions
Eligible patients will be registered to receive the tyrosine kinase inhibitor, ZD1839 (gefitinib; IRESSA) for a minimum of 14 days to a maximum of 45 days; commencing within the 8 days following registration and ceasing 24 hours prior to the time of definitive surgery. No more than 28 days should elapse between the initial breast cancer diagnosis and the first dose of ZD1839 (IRESSA). Each patient should receive a minimum of 10 consecutive days of treatment with ZD1839 (IRESSA) prior to the d
Eligible patients will be registered to receive the tyrosine kinase inhibitor, ZD1839 (gefitinib; IRESSA) for a minimum of 14 days to a maximum of 45 days; commencing within the 8 days following registration and ceasing 24 hours prior to the time of definitive surgery. No more than 28 days should elapse between the initial breast cancer diagnosis and the first dose of ZD1839 (IRESSA). Each patient should receive a minimum of 10 consecutive days of treatment with ZD1839 (IRESSA) prior to the definitive surgery date. During the treatment period, ZD1839 (IRESSA) will be administered orally, once daily, in a 250 mg dose. Follow up of patients will continue beyond definitive surgery with the last planned clinic visit scheduled for 30 days after the last administration of ZD1839 (IRESSA). In the event that related adverse events or serious adverse events are ongoing at the last planned visit, patient follow up will continue as clinically indicated until the event/s resolve or, in the Investigator’s opinion, are unlikely to resolve due to the nature of the condition and/or the patient’s underlying disease.
Sponsors
AstraZeneca Pharmaceuticals
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. 2. Histologically proven invasive breast cancer (adenocarcinoma) through either a core needle biopsy or an incisional biopsy. An excisional biopsy will not be allowed. 3. Tumour must be confined to either the breast or to the breast and ipsilateral axilla. Patients must have a tumour size of >= 2 cm (T1 with T=2cm, T2 - T3). Patient can have either clinically positive (N1) or clinically negative axillary nodes (N0). 4. Patient must provide tumour tissue from four (4) core needle biopsies (or the equivalent with respect to tumour volume acquired from an incisional biopsy) for the molecular analyses being performed by the designated UCLA laboratory. 5. Patient must provide normal skin tissue from two punch biopsies for analyses being performed by the designated UCLA laboratory. 6. Patient must provide a baseline plasma sample for the pharmacokinetic analysis. 7. Age >=18 years. 8. Karnofsky Performance status index >= 80%. 9. Laboratory requirements: (within 28 days prior to registration)a. Hematology:i. Neutrophils >= 1.5 x 109/L ii. Platelets >= 100 x 109/L iii. Hemoglobin >= 10 g/dLb. Hepatic function: i. Total bilirubin <= 1 UNL (patients with a well documented history of Gilbert's Syndrome are eligible)ii. ASAT (SGOT) and ALAT (SGPT) <= 2.5 UNLiii. Alkaline phosphatase <= 5 UNLc. Renal function:i. Creatinine <= 175 µmol/L (2 mg/dL)10. Not more than 28 days from the time of the initial diagnosis and 8 days from registration to the first dose of ZD1839 shall elapse. 11. Patients must be accessible for treatment and the 30-day follow-up. 12. Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
Exclusion criteria
1. Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy). 2. Prior or concurrent ipsilateral radiation therapy for invasive or non-invasive breast cancer. 3. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment. 4. Any T1 (with the exception of T1 with T=2 cm) or T4 or N2 or known N3 or M1 breast cancer.5. Other serious illness or medical condition:a. Concurrent congestive heart failure or unstable angina pectoris, uncontrolled hypertension or high-risk uncontrolled arrhythmias, b. History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent,c. Active uncontrolled infection, d. Pre-existing or concurrent interstitial lung disease. 6. Past or current history of neoplasm other than breast carcinoma, except fora. curatively treated non-melanoma skin cancer, b. in situ carcinoma of the cervix, or c. other cancer curatively treated and with no evidence of disease for at least 5 years.7. Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped at least 4 weeks prior to registration. 8. Concurrent treatment with other experimental drugs or treatment with investigational drugs within 30 days of registration. 9. Prior hormonal therapy with any hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. 10. Currently receiving drugs with known significant CYP 3A4 inhibitory effects (such as ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil, ritonavir, indinavir).11. Concurrent administration with inducers of CYP 3A4 may result in a lower exposure to ZD1839 and are therefore not allowed (eg. phenytoin, carbamazepine, rifampicin, barbiturates, or St. John’s Wort).12. Known allergy reactions to ZD1839 or excipients used in the study.
Outcome results
None listed