A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer

University Hospital of Crete

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: ZD1839

Study type

Interventional

Funder types

Other

Identifiers

NCT00428896

MICRO

Details and patient eligibility

About

Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients

Enrollment

24 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of written informed consent
Histologically or cytologically confirmed breast cancer
Metastatic breast cancer (stage IIIB and IV)
Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. There should be at least one month between end of chemotherapy treatment and trial entry.
ER+ve patients should have received adjuvant hormonal treatment
Detection of CK-19 mRNA positive cells in the blood by real time PCR despite the previous administration of chemotherapy and if appropriate hormonal therapy
Aged 18 years and over
Paraffin-embedded tissue available for tumour histology (EGFR testing, ER, PgR, Her-2-neu testing)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
Patients willing to undergo regular detection of circulating occult tumour cells in the blood by immunocytochemistry and/or RT-PCR
Life expectancy of at least 12 weeks

Exclusion criteria

Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
Known severe hypersensitivity to ZD1839 or any of the excipients of this product
Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR)
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 3 times the ULRR.
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
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