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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428896
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : July 21, 2008
Information provided by:
University Hospital of Crete

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ZD1839 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: 1
Drug: ZD1839
ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
Other Name: Iressa

Primary Outcome Measures :
  1. 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 Measures :
  1. To assess duration of response by means of CK-19 mRNA detection [ Time Frame: 6 months ]
  2. To assess Progression Free Survival by means of CK-19 mRNA detection [ Time Frame: 1 year ]
  3. To assess the safety of ZD1839 administration in this patient population [ Time Frame: Toxicity assessment every month ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00428896

University Hospital of Crete
Heraklion, Crete, Greece, 71110
Sponsors and Collaborators
University Hospital of Crete
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: V.Georgoulias, University Hospital of Crete Identifier: NCT00428896     History of Changes
Other Study ID Numbers: MICRO
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2008

Keywords provided by University Hospital of Crete:
Breast cancer
iressa circulating tumor cells

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action