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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00428896
• Date of registration: 29/01/2007
• Prospective Registration: No
• Primary sponsor: University Hospital of Crete
• Public title: A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer
• Scientific title: A Pilot Feasibility Study to Evaluate the Efficacy of ZD1839 (IRESSA) in Eliminating Chemo- and Hormone- Resistant Cytokeratin-Positive Tumour Cells Circulating in the Blood of Women With Breast Cancer
• Date of first enrolment: April 2005
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00428896
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Greece

Contacts

• Name: Vassilis Georgoulias, MD
• Affiliation: University Hospital of Crete, Dep of Medical Oncology

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: ZD1839

Primary Outcome(s)

Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs [Time Frame: Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment]

Secondary Outcome(s)

To assess the safety of ZD1839 administration in this patient population [Time Frame: Toxicity assessment every month]

To assess Progression Free Survival by means of CK-19 mRNA detection [Time Frame: 1 year]

To assess duration of response by means of CK-19 mRNA detection [Time Frame: 6 months]

Secondary ID(s)

MICRO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors