ANZ 0301 / BCIRG 103 (1839 IL / 0219) : Presurgical Study Evaluating IRESSA

Phase 2

Completed

• Conditions: Invasive Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12607000013460
• Lead Sponsor: AstraZeneca Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 59

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify the molecular alterations which occur in human breast cancer tissue after short term exposure to ZD1839 (IRESSA). Short term exposure to ZD1839 (IRESSA) is defined as a maximum of 45 days (range 14 – 45 days). Molecular alterations occurring due to ZD1839 (IRESSA) exposure will be identified by analyses of tumour tissue samples (core needle or incisional biopsy) and skin punch biopsies collected.[At the time of initial diagnosis (baseline) and again at the time of definitive surgery.];Pharmacokinetic and pharmacodynamic analyses will be conducted on assays of plasma samples collected from the patients.[At baseline, immediately prior to the last dose of ZD1839 (IRESSA), and again 24 hours after the last dose of ZD1839 (IRESSA).]