Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

Breast Cancer Clinical Trial

Official title:

Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3) Oestrogen Receptor Negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239343
• Other study ID #: 1839IL/0712
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2005
• Last updated: January 25, 2011
• Start date: October 2004
• Est. completion date: May 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.

Exclusion Criteria:

• any prior anticancer therapy including gefitinib (Iressa®), epirubicin (Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer, any evidence of clinically active interstitial lung disease , other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• gefitinib

Locations

Country	Name	City	State
Denmark	Research Site	Århus C
Denmark	Research Stie	Herlev
Denmark	Research Site	København N
Denmark	Research Site	København Ø
Denmark	Research Site	Vejle
Norway	Research Site	Oslo
Norway	Research Site	Trondheim
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the complete pathological response rate in the two study groups at trial closure
Secondary	complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population