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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

the complete pathological response rate in the two study groups at trial closure

Principal Investigator

AstraZeneca Oncology Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Denmark: Danish Medicines Agency

Study ID:

1839IL/0712

NCT ID:

NCT00239343

Start Date:

October 2004

Completion Date:

May 2007

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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