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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428896
• Other study ID #: MICRO
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2007
• Last updated: July 18, 2008
• Start date: April 2005
• Est. completion date: March 2008

Study information

• Verified date: July 2008
• Source: University Hospital of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ZD1839
ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months

Locations

Country	Name	City	State
Greece	University Hospital of Crete	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs		Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment	No
Secondary	To assess duration of response by means of CK-19 mRNA detection		6 months	No
Secondary	To assess Progression Free Survival by means of CK-19 mRNA detection		1 year	No
Secondary	To assess the safety of ZD1839 administration in this patient population		Toxicity assessment every month	Yes